A traditional Chinese medicine composition for improving symptoms related to chronic gastritis with spleen and stomach dampness and toxin, a preparation method and application thereof

Abstract

The present application relates to the technical field of traditional Chinese medicine composition and preparation, and particularly relates to a traditional Chinese medicine composition for improving symptoms related to chronic gastritis with damp-heat in the spleen and stomach and toxin, a preparation method and application.The composition is made of fried Huanglian, Wuzhuyu, Baihuasheshecao, Xiangchaecai, calcined Wannaozi, calcined Muli, Hehuanpi, fried Mayi and Zhigancao.The preparation method comprises the following steps of first decocting mineral medicine, decocting all medicines together, filtering, re-decocting, combining and concentrating, and sub-packaging.The present application can be used for preparing a medicine for improving symptoms related to chronic gastritis with damp-heat in the spleen and stomach and toxin and reducing the risk of recurrence.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine compositions and preparations, and in particular to a traditional Chinese medicine composition, preparation method and application for improving symptoms related to damp-heat syndrome of spleen and stomach in chronic gastritis. Background Technology

[0002] Chronic gastritis is a common chronic inflammatory disease of the digestive system, mainly characterized by long-term, repeated damage and inflammation of the gastric mucosa. Patients often experience symptoms such as upper abdominal pain or discomfort, abdominal distension, burning sensation, acid reflux, belching, and loss of appetite. The disease has a long course, and symptoms are prone to recurrence, significantly impacting patients' quality of life. Some cases of chronic gastritis are also associated with pathological progressions such as chronic atrophic gastritis, intestinal metaplasia, and precancerous lesions of the stomach. Therefore, stable control, symptom improvement, and recurrence prevention of chronic gastritis are of significant clinical importance. Chronic gastritis is a common digestive system disease with nonspecific clinical symptoms. Common symptoms include upper abdominal pain, acid reflux, belching, burning sensation, loss of appetite, and abdominal distension. Traditional Chinese medicine treatment has certain advantages in alleviating symptoms and reducing the recurrence rate.

[0003] Currently, Western medicine treatments for chronic gastritis typically employ methods such as acid suppression, gastric mucosa protection, gastric motility enhancement, Helicobacter pylori eradication, and anti-bile reflux, which can alleviate symptoms like acid reflux, stomach pain, and bloating to some extent. However, for some patients with prolonged disease courses, recurrent symptoms, and obvious TCM syndrome manifestations, there are still problems such as a high relapse rate after discontinuation of medication, insufficient overall syndrome improvement, and poor long-term medication adherence. Traditional Chinese medicine considers chronic gastritis to fall under the categories of "stomach pain," "abdominal distension," and "heartburn," with its primary location in the stomach and close relationship to the spleen and liver. Factors such as dietary indiscretion, emotional distress, overwork, and internal damp-heat accumulation can lead to dysfunction of the spleen and stomach's ascending and descending functions, resulting in the internal generation of pathological products such as dampness, heat, blood stasis, and toxins, thus forming the pathological characteristics of a protracted course and recurrent attacks.

[0004] There are already various traditional Chinese medicine compositions in the prior art for treating chronic gastritis or chronic atrophic gastritis. For example, Chinese patent application publication CN113713073A discloses a traditional Chinese medicine composition for treating chronic atrophic gastritis of the spleen and stomach damp-heat type. It is made from raw materials such as Coptis chinensis, Scutellaria baicalensis, Poria cocos, Citrus reticulata peel, Atractylodes lancea, Gallus gallus domesticus gizzard lining, Citrus aurantium, Angelica dahurica, Scutellaria barbata, Hedyotis diffusa, Coix lacryma-jobi, Panax notoginseng, Curcuma zedoaria, eggshell membrane, Rheum palmatum (processed with wine), and Lophatherum gracile. It mainly targets chronic atrophic gastritis of the spleen and stomach damp-heat type by clearing heat and dampness, promoting blood circulation and eliminating stagnation. Although the plan involves heat-clearing, dampness-resolving, and detoxifying drugs such as Coptis chinensis, Poria cocos, and Hedyotis diffusa, it has a large number of ingredients and its treatment approach mainly revolves around chronic atrophic gastritis of the spleen and stomach damp-heat type. It does not address the characteristics of chronic gastritis syndrome, such as "damp-heat with toxicity, latent toxins, and prolonged symptoms with easy recurrence," and does not establish a simplified formula that combines heat-clearing and detoxifying, pungent and bitter herbs to open up and descend, soften hardness and neutralize acid, strengthen the spleen and stomach, and calm the mind and regulate the middle jiao.

[0005] For example, Chinese patent application CN106237307A discloses a traditional Chinese medicine composition and preparation method for treating chronic atrophic gastritis, which involves herbs such as Coptis chinensis, Hedyotis diffusa, Evodia rutaecarpa, malt, and Poria cocos, suggesting that some of these herbs can be used in the treatment of chronic atrophic gastritis. Although this approach is related to the direction of traditional Chinese medicine treatment for chronic gastritis in this field, it does not disclose the overall technical concept of combining roasted Coptis chinensis and Evodia rutaecarpa as a pungent and bitter-descending herb group, Hedyotis diffusa and Evodia rutaecarpa as a heat-clearing and detoxifying herb group, calcined oyster shell and calcined oyster shell as a softening and acid-neutralizing herb group, and further combining Poria cocos, Albizia julibrissin bark, roasted malt, and prepared licorice root to simultaneously strengthen the spleen and stomach, regulate emotions, improve mental fatigue, and reduce the risk of recurrence.

[0006] In summary, existing traditional Chinese medicine (TCM) compositions for chronic gastritis mostly focus on clearing heat and dampness, strengthening the spleen and regulating qi, promoting blood circulation and removing blood stasis, or eliminating stagnation and nodules. They lack sufficient understanding of the specific pathogenesis of "spleen and stomach damp-heat with toxicity" in chronic gastritis, especially regarding the lack of targeted solutions for problems such as recurrent symptoms, prolonged illness, and easy relapse after discontinuation of medication caused by latent toxic pathogens. Furthermore, existing formulas rarely address the multi-dimensional symptoms of epigastric discomfort and burning pain, loose stools, heaviness in the body, stomach discomfort, abdominal distension, bitter taste in the mouth, halitosis, poor appetite, and mental fatigue. Therefore, it is still necessary to develop a TCM composition with clear compatibility, simple ingredients, and the ability to clear stomach toxicity, harmonize the stomach and relieve nausea, neutralize acid and protect the stomach, and strengthen the spleen and regulate the middle jiao in patients with chronic gastritis suffering from spleen and stomach damp-heat with toxicity. This would improve the efficacy in treating chronic gastritis-related symptoms and TCM syndromes, and reduce the risk of relapse after discontinuation of medication. Summary of the Invention

[0007] The purpose of this invention is to provide a traditional Chinese medicine composition for improving symptoms related to spleen and stomach damp-heat syndrome in chronic gastritis, in order to solve the problems of insufficient targeting of existing traditional Chinese medicine compositions for chronic gastritis with spleen and stomach damp-heat syndrome, limited improvement effect on symptoms caused by latent toxins and easy relapse after drug withdrawal, so that the traditional Chinese medicine composition can form a synergistic combination around clearing stomach and detoxifying, pungent opening and bitter descending, softening hardness and neutralizing acid, strengthening spleen and stomach, calming mind and regulating the middle jiao, and can be used to prepare a drug that improves symptoms related to spleen and stomach damp-heat syndrome in chronic gastritis and reduces the risk of relapse.

[0008] Firstly, in order to achieve the above-mentioned objectives, the present invention adopts the following technical solution:

[0009] A traditional Chinese medicine composition for improving symptoms related to damp-heat syndrome with toxicity in the spleen and stomach in chronic gastritis, wherein the traditional Chinese medicine composition is made from the following raw materials in parts by weight:

[0010] 4-8 parts of stir-fried Coptis chinensis, 1-5 parts of Evodia rutaecarpa, 20-40 parts of Hedyotis diffusa, 20-40 parts of fragrant tea leaves, 20-40 parts of calcined oyster shell, 20-40 parts of calcined oyster shell, 10-20 parts of Poria cocos, 10-20 parts of Albizia julibrissin bark, 10-20 parts of stir-fried malt, and 4-8 parts of prepared licorice root.

[0011] The weight ratio of stir-fried Coptis chinensis to Evodia rutaecarpa is 1.5-2.5:1, and the ratio of the total weight of Hedyotis diffusa and Evodia rutaecarpa and the total weight of calcined oyster shell to calcined oyster shell is 0.8-1.2:1.

[0012] Preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight:

[0013] 5-7 parts of stir-fried Coptis chinensis, 2-4 parts of Evodia rutaecarpa, 28-32 parts of Hedyotis diffusa, 28-32 parts of Evodia rutaecarpa, 28-32 parts of calcined oyster shell, 28-32 parts of calcined oyster shell, 14-16 parts of Poria cocos, 14-16 parts of Albizia julibrissin bark, 14-16 parts of stir-fried malt, and 5-7 parts of prepared licorice root.

[0014] Among them, the weight ratio of stir-fried Coptis chinensis to Evodia rutaecarpa is 1.8-2.2:1, the weight ratio of Hedyotis diffusa to Evodia rutaecarpa is 0.9-1.1:1, the weight ratio of calcined oyster shell to calcined oyster shell is 0.9-1.1:1, and the weight ratio of Poria cocos, Albizia julibrissin bark to stir-fried malt is 0.9-1.1:0.9-1.1:0.9-1.1.

[0015] Preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight:

[0016] 6 parts of stir-fried Coptis chinensis, 3 parts of Evodia rutaecarpa, 30 parts of Hedyotis diffusa, 30 parts of fragrant tea vegetable, 30 parts of calcined oyster shell, 30 parts of calcined oyster shell, 15 parts of Poria cocos, 15 parts of Albizia julibrissin bark, 15 parts of stir-fried malt, and 6 parts of prepared licorice root.

[0017] Preferably, the calcined oyster shell and calcined oyster shell have a particle size of 10-80 mesh, and are simmered for 10-30 minutes before cooking.

[0018] Preferably, the traditional Chinese medicine composition is a decoction, concentrated liquid, extract, dry extract powder, granules, capsules, tablets, pills, mixture, oral liquid or powder.

[0019] Secondly, the present invention also provides a method for preparing the aforementioned traditional Chinese medicine composition, comprising the following steps:

[0020] S1. Weigh out the following ingredients according to the specified proportions: stir-fried Coptis chinensis, Evodia rutaecarpa, Hedyotis diffusa, Rhizoma Citri Reticulatae, calcined Ostreae Concha, calcined Ostrea gigas, Poria cocos, Albizia julibrissin bark, stir-fried malt, and prepared licorice root.

[0021] S2. First decoct calcined oyster shell and calcined oyster shell with water to obtain the first decoction system;

[0022] S3. Add stir-fried Coptis chinensis, Evodia rutaecarpa, Hedyotis diffusa, Rhizoma Cimicifugae, Poria cocos, Albizia julibrissin, stir-fried malt and prepared licorice to the first decoction system, continue to decoct, and filter to obtain the first filtrate.

[0023] S4. Add water to the filter residue again and boil it, then filter to obtain the second filtrate;

[0024] S5. Combine the first and second filtrates, concentrate, and obtain the aqueous extract or decoction of the traditional Chinese medicine composition.

[0025] Preferably, in step S2, the amount of water added is 6-12 times the total weight of calcined oyster shell and calcined oyster shell, and the decoction time is 10-30 minutes.

[0026] And / or, in step S3, continue simmering for 30-90 minutes;

[0027] And / or, in step S4, the second simmering time is 20-60 minutes;

[0028] And / or, in step S5, the combined filtrate is concentrated to 350-450 mL per dose and divided into two bags, each containing 175-225 mL.

[0029] Thirdly, the present invention also provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicine for improving symptoms related to spleen and stomach damp-heat syndrome in chronic gastritis, wherein the related symptoms include one or more of the following: recurrent epigastric fullness or burning pain, loose stools, heaviness of the body, stomach discomfort, abdominal distension, bitter taste in the mouth and bad breath, poor appetite or mental fatigue.

[0030] As a preferred symptom, the primary symptoms are recurrent epigastric discomfort or burning pain, loose stools, and general heaviness; the secondary symptoms are stomach discomfort, acid reflux and belching, abdominal distension, bitter taste in the mouth and bad breath, poor appetite and lethargy; combined with a red or purplish-red tongue, a yellow and greasy tongue coating, pale purple and dark sublingual veins, and a slippery or rapid pulse.

[0031] Preferably, the drug is used to prepare a drug that improves the severity of upper gastrointestinal symptoms, TCM syndrome scores, subjective discomfort, psychological stress, or the risk of symptom recurrence after drug withdrawal in patients with chronic atrophic gastritis or chronic non-atrophic gastritis with spleen and stomach damp-heat and toxicity syndrome.

[0032] This invention combines stir-fried Coptis chinensis with Evodia rutaecarpa to form a pungent and bitter formula that clears heat and harmonizes the stomach; combines Hedyotis diffusa with Evodia rutaecarpa to form a formula that clears heat, detoxifies, and resolves carbuncles and nodules; and combines calcined Ostrea gigas with calcined Ostrea gigas to form a formula that softens hardness, neutralizes acid, protects the stomach, and relieves pain. It is further supplemented with Poria cocos, Albizia julibrissin bark, stir-fried malt, and prepared licorice root to strengthen the spleen and stomach, regulate emotions, and alleviate urgency and harmonize the middle jiao. Therefore, the entire formula not only improves epigastric symptoms such as burning pain, stomach upset, acid reflux, belching, and abdominal distension in patients with chronic gastritis, but also improves related symptoms of damp-heat and toxicity in the spleen and stomach, such as loose stools, heaviness in the body, bitter taste in the mouth, halitosis, poor appetite, and mental fatigue. In the clinical study, the experimental group was treated with Qingwei Huadu Decoction, while the control group was treated with omeprazole enteric-coated capsules combined with mosapride citrate dispersible tablets. Both groups underwent 8 weeks of treatment. Evaluation was conducted using multidimensional indicators such as PAGI-SYM, SF-36, VAS, CPSS, and TCM syndrome scores. Results showed that the composition of this invention significantly reduced the severity of upper gastrointestinal symptoms, alleviated subjective discomfort, improved psychological stress, and enhanced quality of life. The overall effective rate of TCM syndromes reached 91.38%, superior to the 70.69% of the control group. The recurrence rate 4 weeks after drug withdrawal was 9.43%, lower than the 44.74% of the control group. No serious adverse reactions were observed during treatment, indicating that this invention has definite efficacy, comprehensive syndrome improvement, low recurrence rate, and good safety. Attached Figure Description

[0033] Figure 1. Completion status of the two groups of patients.

[0034] Figure 2. Comparison of gender between the two groups of patients.

[0035] Figure 3. Comparison of average age between the two groups of patients.

[0036] Figure 4. Comparison of age distribution between the two groups of patients.

[0037] Figure 5 Comparison of the average disease duration between the two groups of patients ( (±s) graph.

[0038] Figure 6. Comparison of disease course distribution between the two groups of patients.

[0039] Figure 7. Comparison of CG classification between the two groups of patients.

[0040] Figure 8. Comparison of the causes of disease in the two groups of patients.

[0041] Figure 9. Comparison of PAGI-SYM scores between the two groups before and after treatment.

[0042] Figure 10. Comparison of PAGI-SYM scores within the two groups before and after treatment.

[0043] Figure 11. Comparison of quality of life scores before and after treatment in the two groups.

[0044] Figure 12. Comparison of VAS scores between the two groups before and after treatment.

[0045] Figure 13. Comparison of VAS scores within the two groups before and after treatment.

[0046] Figure 14. Comparison of CPSS scores between the two groups before and after treatment.

[0047] Figure 15. Comparison of CPSS scores within the two groups before and after treatment.

[0048] Figure 16. Comparison of total TCM syndrome scores between the two groups before and after treatment.

[0049] Figure 17. Comparison of total TCM syndrome scores within the two groups before and after treatment.

[0050] Figure 18. Comparison of TCM syndrome scores before and after treatment in the experimental group.

[0051] Figure 19 Comparison of TCM syndrome scores before and after treatment in the control group.

[0052] Figure 20 Comparison of TCM syndrome scores between the two groups of patients before treatment.

[0053] Figure 21 Comparison of TCM syndrome scores between the two groups of patients after treatment.

[0054] Figure 22 Comparison of TCM syndrome efficacy between the two groups of patients.

[0055] Figure 23 Comparison of recurrence rates between the two groups of patients. Detailed Implementation

[0056] The present invention will be further described in detail below with reference to embodiments, comparative examples, and accompanying drawings. It should be understood that the following embodiments are for illustrative purposes only and are not intended to limit the scope of protection of the present invention; any equivalent substitutions, conventional formulation modifications, or minor adjustments to process parameters made within the scope of the medicinal ingredients, weight ranges, preparation methods, and uses defined by the present invention shall fall within the scope of protection of the present invention.

[0057] The stomach-clearing and detoxifying traditional Chinese medicine composition of the present invention uses stir-fried Coptis chinensis, Evodia rutaecarpa, Hedyotis diffusa, Rhizoma Citri Reticulatae, calcined Ostrea gigas, calcined Ostrea gigas, Poria cocos, Albizia julibrissin bark, stir-fried malt and prepared licorice as raw materials. Among them, stir-fried Coptis chinensis is bitter and cold, clearing the stomach, while Evodia rutaecarpa is pungent and hot, relieving nausea. When the two are combined in a specific ratio, they form a basic drug group that clears heat and harmonizes the stomach. Hedyotis diffusa and Evodia rutaecarpa together form a heat-clearing and detoxifying drug group. The former is more focused on clearing heat and detoxifying, promoting diuresis and resolving lumps, while the latter has the functions of clearing heat and detoxifying, promoting blood circulation and harmonizing the stomach, and relieving stagnation and pain. This allows for targeted intervention in the pathogenesis of "damp-heat with toxicity and toxicity and blood stasis". Calcined oyster shell and calcined oyster shell are both calcined mineral drugs. When combined, they can neutralize acid and protect the membrane, soften hard masses and resolve lumps, and relieve stomach discomfort and acid reflux. Poria cocos strengthens the spleen and eliminates dampness, stir-fried malt harmonizes the stomach and promotes digestion, Albizia julibrissin bark calms the mind and relieves depression, and roasted licorice harmonizes the drugs and relieves pain. The combination of these four drugs can improve poor appetite, heaviness of the body, mental fatigue, and stress-related stomach discomfort. Through the synergistic combination of the above-mentioned drug groups, the present invention forms an overall technical solution of "clearing the stomach and detoxifying, pungent and bitter to lower, softening hardness and neutralizing acid, strengthening the spleen and regulating the middle, calming the mind and harmonizing the stomach".

[0058] I. Active pharmaceutical ingredients and general preparation methods

[0059] All raw materials used in this invention can be prepared Chinese medicinal herbs that meet the requirements of the Chinese Pharmacopoeia or the quality control requirements of hospital-prepared Chinese medicinal herbs. Calcined oyster shell and calcined oyster shell are preferably made of 10-80 mesh particles or coarse powder to facilitate the extraction of active ingredients. Fried Coptis chinensis, Evodia rutaecarpa, Hedyotis diffusa, Rhizoma Cimicifugae, Poria cocos, Albizia julibrissin, fried malt, and prepared licorice root are prepared using conventional specifications. In preparation, calcined oyster shell and calcined oyster shell are first placed in a decoction container, and 6 to 12 times the amount of drinking water or purified water is added. After soaking for 10 to 30 minutes, the mixture is decocted for 10 to 30 minutes. Then, the remaining herbs are added, and the mixture is decocted for another 30 to 90 minutes. The mixture is then filtered to obtain the first filtrate. The residue is added to water and decocted again for 20 to 60 minutes, and then filtered to obtain the second filtrate. The first and second filtrates are combined and concentrated to 350 mL to 450 mL per dose, preferably to 400 mL. The concentrate is then divided into two bags, each containing approximately 200 mL.

[0060] When preparing granules, the combined filtrate can be concentrated under reduced pressure to a clear extract with a relative density of 1.10 to 1.25. Dextrin, maltodextrin, or soluble starch can be added as excipients, mixed thoroughly, and then spray-dried or vacuum-dried. Granulation, sizing, and packaging are then performed to obtain the stomach-clearing and detoxifying granules. When preparing capsules or tablets, the above-mentioned dry extract powder can be mixed with pharmaceutically acceptable excipients such as microcrystalline cellulose, starch, silica, or magnesium stearate, and then formulated into capsules or tablets using conventional methods. Those skilled in the art can choose from mixtures, oral liquids, granules, capsules, tablets, pills, or powders according to the route of administration without requiring inventive effort.

[0061] II. Implementation Examples

[0062] Example 1: Preparation and Clinical Observation of Decoction of Qingwei Huadu Decoction

[0063] This embodiment is a preferred embodiment of the present invention. The raw materials are weighed according to the following prescription: 6g of stir-fried Coptis chinensis, 3g of Evodia rutaecarpa, 30g of Hedyotis diffusa, 30g of Aristolochia debilis, 30g of calcined oyster shell, 30g of calcined oyster shell, 15g of Poria cocos, 15g of Albizia julibrissin bark, 15g of stir-fried malt, and 6g of prepared licorice root. The total weight of the above herbs is 180g, wherein the weight ratio of stir-fried Coptis chinensis to Evodia rutaecarpa is 2:1, the weight ratio of Hedyotis diffusa to Aristolochia debilis is 1:1, the weight ratio of calcined oyster shell to calcined oyster shell is 1:1, and the weight ratio of Poria cocos, Albizia julibrissin bark, and stir-fried malt is 1:1:1.

[0064] In preparation, calcined oyster shell and calcined oyster shell are added to a decoction machine with 900mL of water and decocted for 20 minutes. Then, stir-fried Coptis chinensis, Evodia rutaecarpa, Hedyotis diffusa, Rhizoma Cimicifugae, Poria cocos, Albizia julibrissin bark, stir-fried malt, and prepared Glycyrrhiza uralensis are added, and water is added to a total volume of approximately 1800mL. The decoction is then decocted for 50 minutes and filtered to obtain the first filtrate. The residue is then added to 1200mL of water and decocted for another 35 minutes, followed by filtration to obtain the second filtrate. The two filtrates are combined and concentrated at low temperature to 400mL, then packaged into two 200mL packets. The dosage is 200mL, taken warm, one hour after breakfast and dinner, twice daily for eight weeks.

[0065] Example 2: Preparation of a low-dose stomach-clearing and detoxifying decoction

[0066] The raw materials are weighed according to the following prescription: 5g of stir-fried Coptis chinensis, 2.5g of Evodia rutaecarpa, 28g of Hedyotis diffusa, 28g of Aristolochia debilis, 28g of calcined oyster shell, 28g of calcined oyster shell, 14g of Poria cocos, 14g of Albizia julibrissin bark, 14g of stir-fried malt, and 5g of prepared licorice root. This prescription is within the lower weight range defined by this invention, while still maintaining the core compatibility relationship of approximately 2:1 between stir-fried Coptis chinensis and Evodia rutaecarpa, approximately 1:1 between Hedyotis diffusa and Aristolochia debilis, and approximately 1:1 between calcined oyster shell and calcined oyster shell.

[0067] In preparation, calcined oyster shell and calcined oyster shell are added to a decoction container, along with 800 mL of water, and decocted for 15 minutes. The remaining herbs are then added, and water is added to bring the total volume to 1600 mL. The mixture is decocted for 45 minutes and then filtered. The residue is then added to 1000 mL of water and decocted for another 30 minutes, followed by filtration. The filtrates are combined and concentrated to approximately 380 mL, then packaged into two bags. The resulting decoction is brownish-yellow to brownish-brown in color, with a slightly fragrant odor and a bitter, slightly pungent taste.

[0068] Example 3: Preparation of High-Dose Stomach-Clearing and Detoxifying Decoction

[0069] The raw materials are weighed according to the following prescription: 7g of stir-fried Coptis chinensis, 3.5g of Evodia rutaecarpa, 32g of Hedyotis diffusa, 32g of Aristolochia debilis, 32g of calcined Ostrea gigas, 32g of calcined Ostrea gigas, 16g of Poria cocos, 16g of Albizia julibrissin bark, 16g of stir-fried Hordeum vulgare, and 7g of prepared Glycyrrhiza uralensis. This prescription is within the relatively high weight range defined by this invention, but still maintains the proportional relationship between the core drug components.

[0070] During preparation, calcined oyster shell and calcined oyster shell are decocted in 1000mL of water for 25 minutes; then the remaining drugs are added, water is added to 2000mL, and the mixture is decocted for 60 minutes and filtered; the residue is added to 1300mL of water and decocted for another 40 minutes and filtered; the filtrates are combined, concentrated to 420mL, and packaged into two bags.

[0071] Example 4: Preparation of Stomach-Clearing and Detoxifying Granules

[0072] The ingredients were increased tenfold according to the prescription ratio of Example 1, namely, 60g of stir-fried Coptis chinensis, 30g of Evodia rutaecarpa, 300g of Hedyotis diffusa, 300g of Aristolochia debilis, 300g of calcined oyster shell, 300g of calcined oyster shell, 150g of Poria cocos, 150g of Albizia julibrissin bark, 150g of stir-fried malt, and 60g of prepared licorice root. The calcined oyster shell and calcined oyster shell were decocted for 20 minutes first, then the remaining herbs were added and decocted together. After filtration, the decoction was repeated once, and the filtrates were combined and concentrated under reduced pressure to a clear extract with a relative density of 1.15 to 1.20. An appropriate amount of maltodextrin and soluble starch were added to the clear extract, mixed evenly, and spray-dried to obtain a dry extract powder. This powder was then granulated using either wet or dry methods, sized, and packaged. Each packet contained 90g of the raw herbs. Two packets were taken daily with warm water.

[0073] III. Research Data and Methods

[0074] (a) Research data

[0075] 1. Research Subjects

[0076] The subjects in this study were all from the outpatient and inpatient departments of the Department of Gastroenterology at Zhejiang Provincial Tongde Hospital. The study period was from December 2024 to February 2026. All included patients met the diagnostic criteria for chronic gastritis (spleen and stomach damp-heat with toxicity).

[0077] 2. Diagnostic criteria and syndrome differentiation criteria

[0078] (1) Western medicine diagnostic criteria

[0079] Referring to the "Guidelines for the Diagnosis and Treatment of Chronic Gastritis in China (2022, Shanghai)," the following Western medical diagnostic criteria for chronic gastritis are proposed:

[0080] ① Clinical manifestations: Chronic gastritis lacks clear, specific, and typical symptoms. Some patients may be asymptomatic, while those with symptoms mainly present with persistent or recurrent pain, discomfort, bloating, and burning pain in the upper middle abdomen. It may also be accompanied by functional dyspepsia-related symptoms such as loss of appetite, belching, acid reflux, and nausea. During physical examination, most of these patients do not have obvious positive signs; a few may present with mild tenderness in the upper abdomen.

[0081] ② Endoscopic diagnostic criteria: The mucosal appearance under gastroscopy is an important basis for the clinical diagnosis of chronic gastritis. Under endoscopy, CNAG often shows inflammatory reactions such as hyperemia and edema of the gastric mucosa. Typically, it presents as scattered or diffuse erythema. In some cases, punctate hemorrhages or exudates may also be seen. Mucosal folds may also appear enlarged due to edema. The endoscopic features of CAG show that the mucosa is often red and white, but white is dominant. As glands decrease, the mucosa gradually thins, and the folds tend to flatten or even disappear. In some areas, the underlying vascular patterns can be clearly seen. In some cases with a longer disease course, the gastric mucosal surface may also show fine granular changes or form nodular elevations of varying sizes. This "granular hyperplasia" or "nodular change" is often a structural remodeling of the gastric mucosa during repeated injury and repair, and is also an important identifying feature of atrophic gastritis.

[0082] ③ Pathological diagnostic criteria: Pathological diagnosis requires the collection of tissue specimens from the antrum, angle, or body of the stomach. Additional biopsies are needed for suspicious lesions. A histological examination report must be completed to determine the degree of chronic gastritis inflammation. According to my country's pathological diagnostic criteria for chronic gastritis and the intuitive simulation scoring method of the New Sydney system, the degree of inflammation can be divided into four levels: none (0), mild (+), moderate (++), and severe (+++).

[0083] Diagnosis confirmed: A diagnosis can be made if the patient meets the clinical manifestations of chronic gastritis and the endoscopic or pathological results within 6 months prior to enrollment meet the diagnostic criteria for chronic gastritis.

[0084] (2) Traditional Chinese Medicine diagnostic criteria

[0085] Based on the "Expert Consensus on the Diagnosis and Treatment of Chronic Gastritis with Traditional Chinese Medicine (2023)," the "Technical Guidelines for Clinical Efficacy Evaluation of New Traditional Chinese Medicine Drugs for Chronic Gastritis (Trial)," and the inventor's clinical experience, the following TCM diagnostic criteria for chronic gastritis (spleen and stomach damp-heat with toxicity syndrome) are proposed:

[0086] Main symptoms: ① recurrent epigastric fullness or burning pain; ② loose stools; ③ general heaviness in the body.

[0087] Secondary symptoms: ① stomach discomfort; ② acid reflux and belching; ③ abdominal distension; ④ bitter taste and bad breath; ⑤ poor appetite; ⑥ mental fatigue.

[0088] Tongue appearance: The tongue is red or purplish-red, with a yellow and greasy coating, and the sublingual veins are pale purple and dark.

[0089] Pulse characteristics: Slippery or rapid.

[0090] Diagnosis can be made if the patient presents with two primary symptoms (of which ① is mandatory) and two or more secondary symptoms, combined with tongue and pulse diagnosis.

[0091] 3. Inclusion criteria

[0092] (1) Meets the clinical diagnostic criteria for chronic gastritis in Western medicine.

[0093] (2) Meets the TCM diagnostic criteria for chronic gastritis (spleen and stomach damp-heat with toxicity syndrome).

[0094] (3) Age between 18 and 80 years old.

[0095] (4) The patient has normal cognitive function and can cooperate in completing the relevant assessment scale.

[0096] (5) The patient voluntarily participated in this clinical study and it was approved by the ethics committee.

[0097] 4. Exclusion Criteria

[0098] (1) Those who have Hp infection but have not been cleared.

[0099] (2) Patients with gastric bleeding, or whose pathology shows suspected malignancy or dysplasia.

[0100] (3) Patients with serious diseases of vital organs such as heart, lung, liver and kidney, or blood system diseases or serious mental illnesses.

[0101] (4) Patients under 18 years of age and over 80 years of age.

[0102] (5) Known or suspected allergy to the test drug, or allergic constitution.

[0103] (6) Use of drugs with similar mechanisms of action within 2 weeks, or use of drugs that antagonize the mechanism of action of the enrolled drug regimen.

[0104] (7) Pregnant or lactating women.

[0105] (8) Those who have participated in other clinical trials within 3 months prior to enrollment.

[0106] (9) Patients with poor compliance or cognitive impairment may have serious impacts on the normal collection of data in this experimental study.

[0107] (10) Other circumstances in which the researchers deem it unsuitable for participation in this trial.

[0108] 5. Rejection criteria and dropout criteria

[0109] (1) If a research subject does not actually meet the inclusion criteria but is mistakenly included, or is unable to cooperate in completing the entire trial process, fails to comply with the requirements for use of the investigational drug and the relevant provisions of the trial protocol, or participates in other drug-related clinical trials during the trial period, such research subjects shall be excluded.

[0110] (2) All subjects whose research data is incomplete and therefore cannot be used for subsequent statistical analysis, who have serious adverse reactions or special physiological changes during the trial and are deemed unsuitable to continue participating in the trial, and who have been lost to follow-up or have voluntarily withdrawn from the trial are considered dropout cases.

[0111] 6. Criteria for Termination

[0112] (1) The subject experiences a serious adverse event related to the study drug.

[0113] (2) After comprehensive evaluation by the researchers, it was determined that it was possible to continue the experiment.

[0114] (3) The subject may request to terminate the relevant treatment early due to various factors.

[0115] 7. Ethical requirements

[0116] This application has been approved by the relevant ethical review authorities (Zhejiang Tongde Lun Shen 2024 Yan No. 037), and all subjects have been fully informed of the potential risks associated with this application.

[0117] (II) Research Methods

[0118] 1. Sample size estimation

[0119] This clinical study employed a randomized controlled design, strictly adhering to the principles of randomized controlled trials. The efficacy rate after treatment in both the experimental and control groups was used as the primary evaluation indicator. The sample size was estimated using the following formula:

[0120] ;

[0121] Based on the statistical sample size estimation requirements, we set α = 0.05, and the statistical power is 90%. =1.96, =1.28. Based on previous literature reports and preliminary clinical observations, the estimated effective rate is 90% in the experimental group and 60% in the control group, i.e. =0.9, =0.6. Substituting into the formula, the required sample size for each group is n=58 cases. Referring to the relevant requirements of the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" and taking into account clinical practice, the expected dropout rate for this application is 10%. The final calculation determines n1=n2=64 cases, and a total of 128 subjects are planned to be collected in both groups.

[0122] 2. Grouping method

[0123] This application selects cases collected from December 2024 to November 2025 as the research subjects. The included cases are numbered sequentially according to the order of enrollment, and a random number table is generated using SPSS 26.0 software. The cases are then grouped according to the parity of the random numbers.

[0124] 3. Treatment Plan

[0125] (1) Experimental group

[0126] The treatment involved a modified Qingwei Huadu Decoction, prepared by Zhejiang Provincial Tongde Hospital. Each dose was decocted into two 200mL bags, to be taken warm one hour after breakfast and dinner, for eight consecutive weeks. The basic ingredients of the formula were: 6g of stir-fried Coptis chinensis, 3g of Evodia rutaecarpa, 30g of Hedyotis diffusa, 30g of Fragrant Tea Vegetable, 30g of calcined Ostrea gigas, 30g of calcined Ostrea gigas, 15g of Poria cocos, 15g of Albizia julibrissin bark, 15g of stir-fried Hordeum vulgare, and 6g of prepared Glycyrrhiza uralensis.

[0127] (2) Control group

[0128] Omeprazole enteric-coated capsules (10mg / tablet, Kang Enbei Biopharmaceutical, National Drug Approval Number: H20056062), single dose 10mg, once daily, orally before meals; Mosapride citrate dispersible tablets (5mg / tablet, Lunan Better Pharmaceutical, National Drug Approval Number: H19990317), single dose 5mg, three times daily, orally before meals, for 8 consecutive weeks.

[0129] 4. Observation Indicators

[0130] (1) General observation indicators

[0131] Upon enrollment, baseline information was recorded, including gender, age, disease duration, CG classification, smoking status, alcohol consumption, lifestyle habits, and dietary habits. Pre-enrollment symptoms and prior diagnoses and treatments (past medical history and medications) were also recorded. Statistical analysis was performed to compare the two groups for statistical differences in pre-treatment gender, age, disease duration, CG classification, smoking status, alcohol consumption, lifestyle habits, and dietary habits.

[0132] (2) Upper gastrointestinal symptom severity assessment scale

[0133] The Patient Assessment of Upper Gastrointestinal Disorders-Symptoms Severity Index (PAGI-SYM) was used to quantitatively assess the clinical symptoms of patients before and after treatment. This scale covers 20 symptom items, primarily focusing on upper gastrointestinal symptoms. Each item is categorized into six levels based on symptom severity: none, very mild, mild, moderate, moderate, and severe, with corresponding scoring scales of 0, 1, 2, 3, 4, and 5 points. The total score of the scale was calculated to comprehensively determine the severity of clinical symptoms of chronic gastritis. Both groups of subjects were assessed before treatment and again 8 weeks after treatment. Statistical analysis was conducted by comparing the scores before and after treatment, and graphs were created.

[0134] (3) Health Survey Summary Form

[0135] To comprehensively assess patients' overall quality of life before and after treatment, this application used the MOS36-item short form health survey (SF-36). This scale comprehensively assesses eight dimensions: physical functioning (PF), role-physical functioning (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional functioning (RE), and mental health (MH). Higher scores indicate better health. Scoring involved first calculating the raw scores for each dimension, then converting them to standardized scores using a formula ranging from 0 to 100. The formula was: Standardized Score = (Raw Score – Lowest Possible Score) × 100 / (Highest Possible Score – Lowest Possible Score). Assessments were conducted before treatment and 8 weeks after treatment. Statistical analysis was performed by comparing patients' SF-36 scores before and after treatment, and corresponding charts were generated.

[0136] (4) Visual simulation scoring

[0137] The visual analogue scale (VAS) was used to assess the subjective severity of patients' conditions. VAS is a visual analogue-based rating method that uses 11 numbers from 0 to 10 to reflect the severity of subjective symptoms, with 0 representing no discomfort and 10 representing severe discomfort. During the statistical analysis, patients were asked to choose the number that best reflected their own severity. Specifically, there were four levels: 0 for no discomfort; 1-3 for mild discomfort, not affecting sleep; 4-6 for moderate discomfort, affecting sleep but tolerable; and 7-10 for severe discomfort, causing difficulty falling asleep. Assessments were conducted before treatment and 8 weeks after treatment, and before-and-after comparisons were performed. Statistical analysis was completed, and charts were generated.

[0138] (5) Stress Perception Scale

[0139] The Chinese Perceived Stress Scale (CPSS) was used to quantitatively assess patients' psychological stress levels before and after treatment. This application used the Chinese version of the scale translated and introduced by Chinese scholars Yang Tingzhong and Huang Hanteng in 2003, which contains 14 evaluation items. A 5-point Likert scale (0-4 points) was used, with items 4, 5, 6, 7, 9, 10, and 13 being reverse-scored. A higher final score indicated a more significant level of stress. The scoring criteria were: a score <28 was considered normal, 29-42 was considered relatively high stress, and 43-56 was considered excessive stress.

[0140] (6) Traditional Chinese Medicine Syndrome Scale

[0141] A Traditional Chinese Medicine (TCM) syndrome scale was developed based on the "Technical Guidelines for Clinical Efficacy Evaluation of New Traditional Chinese Medicine Drugs for Chronic Gastritis (Trial Implementation)" and the inventor's clinical experience. The scale scores each clinical symptom according to its severity, classifying all symptoms into four levels: none, mild, moderate, and severe. Primary symptoms are assigned scores of 0, 2, 4, and 6 points, while secondary symptoms are assigned scores of 0, 1, 2, and 3 points. Patients' clinical symptoms were quantitatively scored before treatment and 8 weeks after treatment. The scores for each TCM syndrome and the total score were calculated. Comparisons of individual TCM syndrome scores and the total score before and after treatment were performed, and statistical analysis was conducted to create charts and graphs.

[0142] (7) Assessment of recurrence

[0143] For patients deemed effective after treatment, a follow-up was conducted 4 weeks after the end of treatment, via telephone or in-person visit. During the follow-up, a Traditional Chinese Medicine syndrome scale was used to reassess the patient's symptoms, and data on the recurrence of chronic gastritis-related symptoms were collected for statistical analysis to calculate the recurrence rate.

[0144] (8) Safety observation index assessment

[0145] General vital signs of both groups of subjects were monitored before and after treatment, including blood pressure, respiration, and heart rate. Simultaneously, to comprehensively assess the safety of the investigational drug, relevant laboratory data were collected from subjects before treatment and 8 weeks after treatment, including complete blood count, urinalysis, stool analysis, coagulation function tests, liver and kidney function tests, and electrocardiograms. Adverse events or suspected symptoms occurring during treatment were recorded in detail, including their timing, characteristics, and corresponding management measures. The correlation between these events and the investigational drug was analyzed in conjunction with the medication use.

[0146] 5. Evaluation Criteria

[0147] (1) Evaluation criteria for TCM syndrome differentiation and treatment efficacy

[0148] This application employs the nimodipine method to quantitatively evaluate the efficacy of TCM syndromes. The efficacy index is calculated based on changes in scores before and after treatment, using the formula: Efficacy Index = (Pre-treatment score - Post-treatment score) / Pre-treatment score × 100%. Based on the efficacy index, clinical outcomes are categorized into four levels:

[0149] ① Cured: The efficacy index is not less than 95%, and the symptoms and signs have basically disappeared.

[0150] ②Significant effect: 70% ≤ efficacy index < 95%, with significant improvement in symptoms and signs.

[0151] ③ Effective: 30% ≤ efficacy index < 70%, symptoms and signs show some improvement.

[0152] ④ Ineffective: The efficacy index is less than 30%, and there is no improvement in symptoms and signs, or the symptoms and signs are aggravated.

[0153] Overall effective rate = (number of cured cases + number of cases with significant effect + number of effective cases) / total number of cases × 100%.

[0154] Recurrence rate evaluation criteria

[0155] During the follow-up phase, the total scores of the two groups of subjects were statistically analyzed, and the recurrence index was calculated to assess the recurrence rate. If the recurrence index exceeded 30%, it was considered to have met the recurrence criteria. Based on this, the recurrence rates of the two groups were further analyzed.

[0156] ①Relapse index = (total follow-up score - total score after treatment) / total follow-up score × 100%.

[0157] ② Recurrence rate = Number of recurrences / Number of follow-up cases × 100%.

[0158] (3) Safety evaluation standards

[0159] Referring to the relevant provisions in the 2002 edition of the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial Implementation)," the safety of investigational drugs is classified into the following four levels:

[0160] ① Grade I: Good safety profile, with no adverse reactions observed throughout the treatment.

[0161] ② Grade II: The safety profile is good. Even if adverse reactions occur, no special intervention is required, and subsequent drug administration can continue.

[0162] ③ Level III: Safety issues exist; adverse drug reactions occurred during the trial, but the trial can continue after treatment.

[0163] ④ Grade IV: Clinical trials must be terminated immediately due to serious adverse reactions.

[0164] 6. Statistical methods

[0165] All statistical analyses in this application were performed using SPSS 26.0 statistical software. The selection of statistical methods was based on the data distribution characteristics and data type. For normally distributed continuous data, the t-test was used; for categorical data, the chi-square test was used; and for data that did not meet the normal distribution or were ordinal data, the rank-sum test was used. Data description followed the distribution law: normally distributed continuous data were expressed as mean ± standard deviation (...). For data expressed as mean ± standard deviation (s), non-normally distributed data are presented using the median combined with quartiles, i.e., M(P25, P75). This application sets the significance level at α = 0.05. If P < 0.05, the difference between groups is considered statistically significant; if P > 0.05, the difference is considered not statistically significant.

[0166] IV. Research Results

[0167] (a) Case completion status

[0168] This application enrolled 128 participants from December 2024 to November 2025, who were randomly divided into an experimental group and a control group, with 64 participants in each group. In the experimental group, 3 patients dropped out due to symptom relief and refusal to continue medication, 1 patient dropped out due to discontinuing traditional Chinese medicine while traveling abroad, 1 patient was excluded for self-medicating with additional Western medicine, and 1 patient was excluded for not adhering to the prescribed dosage of traditional Chinese medicine. In the control group, 2 patients were excluded for non-compliance with questionnaire completion, 1 patient was excluded for adding other medications, and 3 patients dropped out due to personal refusal. A total of 116 cases were completed, with 58 cases in each of the experimental and control groups, resulting in an overall dropout rate of 9.38%. (See Table 1 for details.) Figure 1 )

[0169] Table 1 Completion status of the two groups of patients

[0170] (II) Comparison of General Data

[0171] 1. Gender comparison

[0172] Of the 116 participants ultimately included in this application, 59 were male and 57 were female. The experimental group consisted of 30 males and 28 females (male-to-female ratio 1.07:1), while the control group consisted of 29 males and 29 females (male-to-female ratio 1:1). Statistical analysis showed no significant difference in gender composition between the two groups (P > 0.05), indicating comparability. (See Table 2 for details.) Figure 2 )

[0173] Table 2 Comparison of gender between the two groups of patients

[0174] Note: The chi-square test was used to compare the sex ratios between the two patient groups.

[0175] 2. Age comparison

[0176] The oldest patient included in this application was 76 years old, and the youngest was 23 years old. The age distribution of the experimental group ranged from 29 to 75 years, with a mean age of (54.88±10.77) years. Specifically, there was 1 patient aged 20-29, 3 patients aged 30-39, 14 patients aged 40-49, 20 patients aged 50-59, 13 patients aged 60-69, and 7 patients aged 70-79. The age distribution of the control group ranged from 23 to 76 years, with a mean age of (55.38±14.6) years. Specifically, there were 3 patients aged 20-29, 7 patients aged 30-39, 9 patients aged 40-49, 15 patients aged 50-59, 10 patients aged 60-69, and 14 patients aged 70-79. The age distribution and mean age of the two groups showed no statistically significant difference (P>0.05), indicating comparability between the groups. (See Table 3 for details.) Figure 3 , Figure 4 )

[0177] Table 3 Comparison of ages between the two groups of patients ( ±s)

[0178] Note: Independent samples t-test was used to compare the mean age between the two groups of patients.

[0179] 3. Comparison of disease course

[0180] The disease duration of patients included in this application ranged from 0.3 to 10 years. The disease duration in the experimental group ranged from 0.3 to 10 years, with a mean duration of (2.75 ± 1.86) years. The disease duration in the control group ranged from 0.4 to 7.5 years, with a mean duration of (2.51 ± 1.80) years. No significant differences were found between the two groups in terms of disease duration distribution and mean disease duration at baseline (P > 0.05), indicating comparability between the groups. (See Table 4 for details.) Figure 5 , Figure 6 )

[0181] Table 4 Comparison of disease course between the two groups of patients ( ±s)

[0182] Note: Independent samples t-test was used to compare the mean disease duration between the two groups of patients.

[0183] 4. Comparison of the two CG classification cases

[0184] This application included 69 patients with chronic adenocarcinoma (CAG) and 47 patients with non-cancerous angina (CNAG). The experimental group consisted of 37 CAG patients and 21 CNAG patients, a ratio of 1.76:1; the control group consisted of 32 CAG patients and 26 CNAG patients, a ratio of 1.23:1. There was no statistically significant difference in CG subtype composition between the experimental and control groups (P > 0.05), indicating comparability between the groups. (See Table 5 for details.) Figure 7 )

[0185] Table 5 Comparison of CG subtypes between the two groups of patients

[0186] Note: Chi-square test was used to compare CG classifications between the two patient groups.

[0187] 5. Comparison of inducing factors for the disease

[0188] Among the subjects included in this study, the experimental group consisted of 20 smokers, 23 drinkers, 31 with irregular sleep patterns, 17 with a preference for rich and fatty foods, and 10 with other contributing factors; the control group consisted of 21 smokers, 22 drinkers, 33 with irregular sleep patterns, 17 with a preference for rich and fatty foods, and 9 with other contributing factors. There were no statistically significant differences in the distribution of each contributing factor between the experimental and control groups (P > 0.05), indicating comparability between the groups. (See Table 6 for details.) Figure 8 )

[0189] Table 6 Comparison of the precipitating factors in the two groups of patients

[0190] Note: The chi-square test was used to compare the precipitating factors between the two groups of patients.

[0191] (III) Comparison of Observation Indicators

[0192] 1. Comparison of PAGI-SYM scores

[0193] (1) Comparison of PAGI-SYM scores between the two groups before and after treatment

[0194] The PAGI-SYM scores of both groups before and after treatment were normal and homogeneous in variance. An independent samples t-test was used for inter-group comparisons. Before treatment, the total score in the experimental group was (29.41±3.61) points, and in the control group it was (29.17±2.62) points. There was no statistically significant difference in PAGI-SYM scores between the two groups (P>0.05), indicating comparable baseline levels. After 8 weeks of treatment, the total score in the experimental group was (10.81±4.12) points, and in the control group it was (19.55±3.11) points. The experimental group score was significantly lower than the control group score, with a statistically significant difference (P<0.05). (See Table 7 for details.) Figure 9 )

[0195] Table 7 Comparison of PAGI-SYM scores between the two groups before and after treatment ( ±s)

[0196] Note: Independent samples t-test was used to compare PAGI-SYM scores between the two groups before and after treatment.

[0197] (2) Comparison of PAGI-SYM scores between the two groups before and after treatment

[0198] The PAGI-SYM scores of the two groups of patients before and after treatment were compared within each group. The data met the criteria for a paired-samples t-test, which was then performed. The results showed that the scores in both groups were significantly lower after treatment than before treatment, and the differences were statistically significant (P < 0.05). (See Table 8 for details.) Figure 10 )

[0199] Table 8 Comparison of PAGI-SYM scores within the two groups before and after treatment ( ±s)

[0200] Note: Paired-samples t-test was used to compare PAGI-SYM scores within both groups before and after treatment.

[0201] 2. SF-36 rating comparison

[0202] Scores on all eight dimensions of the SF-36 scale were compared and analyzed. All data were found to be normally distributed and homogeneous in variance. Paired-samples t-tests were used for within-group comparisons, and independent-samples t-tests were used for between-group comparisons. Before treatment, there were no statistically significant differences in scores on the eight dimensions (PF, RP, BP, GH, VT, SF, RE, MH) between the two groups (P > 0.05). Baseline data were balanced at enrollment, and the groups were comparable. After 8 weeks of treatment, scores on all eight dimensions in both groups showed significant improvement compared to before treatment (P < 0.05). After treatment, the experimental group scored significantly better than the control group on all eight dimensions (P < 0.05). (See Table 9 for details) Figure 11 )

[0203] Table 9 Comparison of quality of life scores before and after treatment in the two groups ( ±s)

[0204] Table 10 (Continued) Comparison of quality of life scores before and after treatment in the two groups ( ±s)

[0205] Note: Independent samples t-test was used to compare SF-36 scores between the two groups before and after treatment; paired samples t-test was used to compare SF-36 scores within each group before and after treatment.

[0206] 3. Comparison of VAS scores

[0207] (1) Comparison of VAS scores between the two groups before and after treatment

[0208] Statistical analysis was performed on the VAS scores of the two groups of patients before and after treatment. The data were found to be normally distributed and homogeneous in variance. An independent samples t-test was used for inter-group comparisons. Before treatment, there was no significant difference in VAS scores between the two groups (P > 0.05), and their baseline levels were comparable. After treatment, the score in the experimental group was significantly lower than that in the control group, and the difference was statistically significant (P < 0.05). (See Table 10 for details.) Figure 12 )

[0209] Table 11 Comparison of VAS scores between the two groups before and after treatment ( ±s)

[0210] Note: Independent samples t-test was used to compare VAS scores between the two groups before and after treatment.

[0211] (2) Comparison of VAS scores between the two groups before and after treatment

[0212] Within-group comparisons were performed on the VAS scores of the two groups before and after treatment. The data met the criteria for a paired-samples t-test, and the results were analyzed using this test. The results showed that compared with pre-treatment scores, the VAS scores of both groups decreased significantly after treatment, with statistically significant differences (P < 0.05). (See Table 11 for details.) Figure 13 )

[0213] Table 12 Comparison of VAS scores within the two groups before and after treatment ( ±s)

[0214] Note: Paired-samples t-test was used to compare VAS scores within each group before and after treatment.

[0215] 4. Comparison of CPSS scores

[0216] (1) Comparison of CPSS scores between the two groups before and after treatment

[0217] Statistical analysis was performed on the CPSS scores of the two groups of patients before and after treatment. The data met the requirements of normal distribution and homogeneity of variance. Independent samples t-test was used for inter-group comparisons. Before treatment, there was no significant difference in CPSS scores between the two groups (P>0.05), and the baseline levels were comparable. After treatment, the score of the experimental group was significantly lower than that of the control group, and the difference was statistically significant (P<0.05). (See Table 12 for details) Figure 14 )

[0218] Table 13 Comparison of CPSS scores between the two groups before and after treatment ( ±s)

[0219] Note: Independent samples t-test was used to compare CPSS scores between the two groups before and after treatment.

[0220] (2) Comparison of CPSS scores between the two groups before and after treatment

[0221] Within-group comparisons were performed on the CPSS scores of the two groups before and after treatment. Data met the criteria for a paired-samples t-test, which was then used for analysis. Results showed that the CPSS scores in both groups decreased significantly after treatment compared to before treatment, with statistically significant differences (P < 0.05). (See Table 13 for details.) Figure 15 )

[0222] Table 14 Comparison of CPSS scores between the two groups before and after treatment ( ±s)

[0223] Note: Paired-samples t-test was used to compare CPSS scores within both groups before and after treatment.

[0224] 5. Comparison of TCM syndrome scores

[0225] (1) Comparison of total TCM syndrome scores between the two groups before and after treatment

[0226] Statistical analysis was performed on the total TCM syndrome scores of the two groups of patients before and after treatment. The data met the requirements of normal distribution and homogeneity of variance. Independent samples t-test was used for inter-group comparisons. Before treatment, there was no statistically significant difference in the total TCM syndrome scores between the two groups (P>0.05), and the baselines were comparable. After treatment, the scores of the experimental group were significantly lower than those of the control group, and the difference was statistically significant (P<0.05). (See Table 14 for details) Figure 16 )

[0227] Table 15 Comparison of total TCM syndrome scores between the two groups before and after treatment ( ±s)

[0228] Note: Independent samples t-test was used to compare the total scores of TCM syndromes between the two groups of patients before and after treatment.

[0229] (2) Comparison of total TCM syndrome scores within the two groups before and after treatment

[0230] The total TCM syndrome scores of the two groups of patients before and after treatment were compared within each group. Data meeting the criteria for paired-samples t-test were analyzed using this test. Results showed that the total TCM syndrome scores of both groups were significantly lower after treatment than before treatment, with statistically significant differences (P < 0.05). (See Table 15 for details.) Figure 17 )

[0231] Table 16 Comparison of total TCM syndrome scores within the two groups before and after treatment ( ±s)

[0232] Note: The total scores of TCM syndromes within each group before and after treatment were compared using a paired-samples t-test.

[0233] (3) Comparison of TCM syndrome scores before and after treatment in the two groups

[0234] The scores of various TCM syndromes before and after treatment were analyzed in both groups of patients. Since the data did not conform to a normal distribution, the rank-sum test was used for comparative analysis. Before treatment, the scores of the two groups of patients for nine syndromes—epigastric discomfort and burning pain, loose stools, heaviness of the body, stomach discomfort, bitter taste in the mouth and halitosis, poor appetite, fatigue, acid reflux and belching, and abdominal distension—were compared. There were no statistically significant differences in any of these scores (P > 0.05), indicating that the baselines were comparable. Comparing the scores of various symptoms within the two groups before and after treatment, the experimental group showed significant efficacy in improving patients' epigastric pain, loose stools, heaviness of the body, stomach upset, acid reflux and belching, abdominal distension, bitter taste and halitosis, poor appetite and mental fatigue (P<0.05). The control group showed no significant improvement in bitter taste and halitosis and mental fatigue (P>0.05), but showed significant efficacy in improving epigastric pain, loose stools, heaviness of the body, stomach upset, acid reflux and belching, abdominal distension and poor appetite (P<0.05). Comparing the scores of various symptoms between the two groups after treatment, the experimental group showed significantly better efficacy in improving symptoms such as epigastric discomfort and burning pain, loose stools, heaviness in the body, stomach upset, abdominal distension, bitter taste in the mouth, halitosis, poor appetite, and drowsiness (P < 0.05). However, the efficacy in improving acid reflux and belching was the same as the control group (P > 0.05). (See Table 16 and Figure 18 for details.) Figure 21 )

[0235] Table 17 Comparison of TCM syndrome scores before and after treatment in the two groups of patients (M (P25, P75))

[0236] Note: The rank-sum test was used to compare the scores of various TCM syndromes before and after treatment in the two groups of patients.

[0237] 6. Comparison of overall efficacy of traditional Chinese medicine

[0238] After 8 weeks of treatment, the total effective rate of TCM syndrome differentiation in the experimental group was 91.38%, while that in the control group was 70.69%. The difference in the total effective rate between the two groups was statistically significant (P < 0.05). (See Table 17 for details) Figure 22 )

[0239] Table 18 Comparison of TCM syndrome efficacy between the two groups of patients

[0240] Note: The chi-square test was used to compare the improvement rates of TCM syndromes between the two groups of patients.

[0241] 7. Comparison of recurrence rates

[0242] Four weeks after the end of treatment, patients who responded to treatment in both the experimental and control groups were followed up. In the experimental group, 53 patients responded, and all 53 were successfully followed up, with 5 relapsed after 4 weeks. In the control group, 41 patients responded, but 3 patients could not be contacted, resulting in 38 successful follow-ups, with 17 relapsed after 4 weeks. The relapse rate difference between the two groups was statistically significant (P < 0.05). (See Table 18 for details.) Figure 23 )

[0243] Table 19 Comparison of recurrence rates between the two groups of patients

[0244] Note: The recurrence rate of the two groups of patients was compared using the chi-square test.

[0245] 8. Comparison of safety and adverse reactions

[0246] During the 8-week clinical observation period, all subjects had stable vital signs, and no significant abnormalities were found in the results of safety indicators such as routine blood tests, coagulation function, liver and kidney function, and electrocardiogram. No adverse events were observed.

[0247] V. Analysis and Discussion

[0248] (a) Understanding of chronic gastritis in this application

[0249] 1. Etiology and pathogenesis of chronic gastritis with damp-heat and toxicity in the spleen and stomach

[0250] The etiology and pathogenesis of chronic gastritis are complex and diverse, but are closely related to spleen and stomach dysfunction, external pathogenic invasion, and internal accumulation of pathogenic factors. Through long-term clinical observation, the inventors have found that some patients with chronic gastritis exhibit distinctive clinical manifestations, often including epigastric fullness and burning pain, bitter taste in the mouth, foul odor, acid reflux and belching, poor appetite and nausea, constipation, fatigue, a red or purplish-red tongue with a yellow and greasy coating, pale purple and dark sublingual veins, and a slippery or rapid pulse. These conditions are often protracted and difficult to cure, with frequent relapses. While conventional methods of clearing heat and resolving dampness can temporarily alleviate the symptoms, the root cause remains elusive. Through systematic differentiation and analysis, the inventors believe that the core pathogenesis is spleen and stomach disharmony and damp-heat with toxicity, summarizing this syndrome as spleen and stomach damp-heat with toxicity syndrome, with spleen and stomach disharmony as the root cause, damp-heat accumulation as the manifestation, and latent toxic pathogens as the key mechanism.

[0251] From an etiological perspective, this disease is mostly caused by the interaction of external pathogens and internal injuries, which then lead to the generation of damp-heat. Regarding external pathogens, untimely or regional damp-heat and turbid evils directly invade the middle jiao, suppressing spleen yang and obstructing stomach qi; this is the initial state of "dampness suppressing heat" as described in the *Treatise on Warm Diseases*. The primary cause of internal injury is improper diet. Long-term indulgence in rich, fatty, spicy, and fried foods, or excessive alcohol consumption, easily generates damp-heat, obstructing the spleen and stomach; this is the mechanism of "damp-heat qi unable to be transformed" as described by Danxi. Secondly, emotional imbalance is a major factor; worry injures the spleen, and anger injures the liver. When the liver fails to regulate qi, it rebels and invades the stomach, causing disorder in the ascending and descending functions of the middle jiao, abnormal distribution of body fluids, internal generation of dampness and turbidity, which then transforms into heat, forming a situation of "earth obstructing wood" or "liver and stomach stagnation with heat." Furthermore, insufficient constitution or overwork leading to internal injury, resulting in a weak spleen and stomach, impaired function of the middle jiao (middle burner), and failure to transform food and water into essential nutrients, can lead to dampness and turbidity, which, if prolonged, can transform into heat. Dampness is heavy, turbid, and sticky, easily obstructing the flow of qi, while heat is rising and scorching, easily damaging body fluids. When dampness and heat combine, they become sticky and difficult to resolve, obstructing the middle jiao, resulting in symptoms such as burning pain and fullness in the stomach, heartburn and acid reflux, dry mouth and bitter taste, poor appetite and nausea, a red tongue with a yellow and greasy coating, and a slippery and rapid pulse—all signs of damp-heat obstruction in the middle jiao.

[0252] If the pathogenesis is limited to damp-heat, methods such as clearing heat and resolving dampness, regulating qi and harmonizing the stomach are often effective. However, the stubbornness and recurrence of this condition lie in the deeper pathological element of "toxin" that arises from the damp-heat. The generation and latent nature of toxins are the core driving factors behind the protracted and difficult-to-cure nature of this disease, its complex symptoms, its recurrent attacks, and its tendency to transform into precancerous lesions of the stomach. When damp-heat lingers for a long time, it refines body fluids into turbidity, burns the collaterals into blood stasis, and the turbidity and blood stasis congeal and accumulate without resolution, thus generating "toxin." This is what the *Synopsis of Prescriptions of the Golden Chamber* refers to as: "Toxin is the accumulation and unresolved evil qi." Toxins are both pathogenic factors and pathological products, formed by the accumulation and transformation of various evils. Professor Lu Zheng's "Treatise on Toxic Syndromes" further categorizes it as "secondary toxic evils," which are often caused by pathological products such as qi stagnation, blood stasis, phlegm accumulation, and dampness obstruction. Under the long-term effects of "stagnation, stasis, heat, and putrefaction," intangible evils accumulate into tangible toxins, which are characterized by turbidity, stagnation, damage to collaterals, injury to the body's vital energy, and mutability.

[0253] In the evolution of chronic gastritis, the generation of toxins mainly follows these pathways: First, damp-heat breeds toxins. Damp-heat stagnates between the spleen and stomach membranes, like a fermenting stagnation, leading to obstruction of Qi. With no way out, the toxin accumulates over time, transforming from "damp-heat" into "damp-heat toxins." This toxin combines the turbidity and stickiness of dampness with the scorching and excitatory nature of heat, damaging the stomach's network and ruining its structure far more effectively than simple damp-heat. Second, blood stasis transforms into toxins. "Initially, the disease affects Qi; with prolonged illness, it enters the network." Damp-heat obstructs Qi, affecting the blood and causing obstruction of the stomach's network. Stagnant blood further congests Qi, hindering the generation of new blood, leading to local malnourishment, stagnation, and the transformation of stagnation into heat. The combination of heat and stasis generates "stasis toxins." Ye Tianshi's *Clinical Guide to Medical Cases* states, "Prolonged pain inevitably enters the collaterals, hindering the flow of qi and blood." The mutual binding of blood stasis and toxins, penetrating deep into the blood vessels, is a crucial pathological mechanism underlying organic lesions such as gastric mucosal atrophy, intestinal metaplasia, and dysplasia, and is also a significant reason for the prolonged and recurring symptoms. Thirdly, phlegm and turbidity congeal toxins. The spleen is the source of phlegm; damp heat impairs the spleen's function of transportation and transformation, leading to the accumulation of dampness and the formation of phlegm. Phlegm and dampness combine with heat, becoming sticky and difficult to resolve, eventually congealing into "phlegm toxins," adhering to the stomach and intestines, exacerbating mucosal erosion, hyperplasia, and polyp formation. Fourthly, emotional distress and food stagnation breed toxins. Excessive emotional distress leads to liver qi stagnation; prolonged qi stagnation can transform into fire or generate "stagnation toxins." Improper diet, food stagnation, putrefaction, and foul odor can also produce "food stagnation toxins."

[0254] The various internally generated toxins and damp-heat turbidity mutually nourish and merge, forming a complex pathological state of "damp-heat with toxins." These damp-heat toxins lurk in the stomach's lining and collaterals, causing the condition to be insidious and persistent, with symptoms fluctuating in severity and recurring. Ordinary heat-clearing and dampness-removing drugs are unable to reach the affected area and completely eliminate the toxins. Even worse, their corrosive and damaging effects directly destroy the stomach's fine structure and function, depleting stomach yin and qi, causing the gastric mucosa to lose nourishment and repair, impairing its vitality, and gradually evolving from superficial gastritis to atrophy, intestinal metaplasia, dysplasia, and even cancer. The *Medical Essentials: Accumulations* states, "The formation of accumulations is due to insufficient vital energy, which then allows pathogenic factors to take hold." Damp-heat toxins represent a deepened and solidified form of this "pathogenic factors taking hold."

[0255] Therefore, early identification and timely intervention of pathogenic toxins are crucial for the treatment and prognosis of chronic gastritis. The latent presence of pathogenic toxins is both a consequence of the early pathological process and a core driving factor leading to a protracted and difficult-to-cure stage of the disease and a poor outcome. In the early stages of the disease, when damp-heat is just beginning and pathogenic toxins are not yet prevalent, early application of detoxification methods based on clearing dampness and heat can quickly eliminate pathogenic toxins, block the progression of the disease, and often results in significant therapeutic effects, a shorter treatment course, and a lower recurrence rate. If the disease progresses to the middle stage, with prolonged accumulation of damp-heat, it not only depletes the spleen and stomach's vital energy, leading to disharmony of the spleen and stomach and gradual depletion of vital energy, but also easily generates secondary pathogenic factors such as qi stagnation, food retention, phlegm obstruction, and blood stasis. The intertwining of these pathogenic factors generates latent pathogenic toxins. At this point, the application of detoxification methods becomes key to blocking the progression of the disease and preventing its prolongation.

[0256] 2. Exploring the Core Value of Detoxification Methods in the Treatment of Chronic Gastritis

[0257] Detoxification is key to halting the progression of the disease and reversing cancerous changes. Toxic pathogens are the product of the accumulation and unresolved pathological factors such as damp-heat, blood stasis, and phlegm. They are the core factor contributing to the lingering and recurring nature of the disease, and the driving force propelling chronic gastritis from simple inflammation to atrophy, intestinal metaplasia, dysplasia, and even cancer. The essence of toxic pathogens is a "difficult-to-resolve," "deeply lurking," and "destructive" pathological state. When toxic pathogens are cleared, the pathological products they adhere to, such as phlegm, dampness, and blood stasis, lose their core of stagnation and become easier to differentiate and dissipate. Therefore, while conventional methods of clearing heat and dampness, regulating qi, and harmonizing the stomach can alleviate some symptoms, they are often insufficient to address already formed "toxic pathogens." The Qingwei Huadu Decoction uses detoxifying herbs such as Hedyotis diffusa and Fragrant Tea Vegetable, which are specifically targeted at this critical turning point in the pathogenesis. Its significance goes far beyond simple anti-inflammatory treatment. It directly eliminates or disintegrates the "toxic evil" that has already formed, cuts off its natural pathological process of "eroding the collaterals and damaging the body", and prevents recurrence. It is a concrete practice of the idea of ​​"treating disease before it occurs".

[0258] Detoxification is a prerequisite for unblocking qi and blood and repairing the stomach collaterals. Internally lurking toxins obstruct qi flow and damage blood vessels, leading to stomach collateral stagnation, mucosal malnourishment, and the progression of chronic illness into the collaterals. Clearing toxins from the stomach collaterals not only eliminates their persistent damaging effects but also removes obstacles to the repair and regeneration of the gastric mucosa. Detoxifying agents often enter the blood, promoting blood circulation and removing blood stasis, clearing heat toxins from the blood and unblocking stagnant collaterals. While Ye Tianshi's theory of "chronic illness entering the collaterals" often involved using pungent and moistening agents to unblock the collaterals or using insect-based remedies, the detoxification method invented by the inventor of this method actually removes the "toxins" from the collaterals at a deeper level, allowing qi and blood to nourish the stomach collaterals and creating the necessary microenvironment for the repair and regeneration of damaged mucosa.

[0259] Detoxification is fundamental to eliminating latent pathogens and preventing recurrence. The latent nature of toxins is a key reason why chronic gastritis is difficult to cure and prone to relapse. These toxins lie deep within the gastric lining and vessels, like oil mixed with flour, difficult to clear quickly. Conventional treatments may temporarily suppress the symptoms of damp-heat, but if the latent toxins are not eliminated, they will re-emerge due to factors such as improper diet, emotional imbalance, or external pathogens, combining with newly formed toxins to cause a relapse. The application of detoxification methods targets this latent root cause, aiming to search for and clear the toxins deeply hidden within the gastric lining and vessels, eradicating the root of the disease, thereby improving the clinical cure rate and reducing long-term recurrence.

[0260] 3. Explanation of the formula for Qingwei Huadu Decoction

[0261] The Qingwei Huadu Decoction is an empirical formula created by the inventor for chronic gastritis with damp-heat and toxicity in the spleen and stomach. The formula uses stir-fried Coptis chinensis as the chief herb, which clears heat, dries dampness, harmonizes the stomach, and detoxifies. Hedyotis diffusa and sage are the assistant herbs, clearing heat, detoxifying, and removing phlegm, blood stasis, and toxins. Calcined oyster shell removes phlegm and dampness, protects the stomach, neutralizes acid, and relieves pain; calcined oyster shell astringes, consolidates, and relieves pain, clears phlegm and dampness in the stomach, and also has a calming effect; Evodia rutaecarpa warms and transforms cold and dampness, and when combined with Coptis chinensis, it counteracts its coldness; Poria cocos strengthens the spleen, transforms dampness, and aids digestion, eliminating the source of phlegm and dampness; Albizia julibrissin bark harmonizes the stomach, calms the mind, and astringes sores; stir-fried malt soothes the liver, regulates the flow of qi, harmonizes the middle jiao, and strengthens the spleen; roasted licorice root strengthens the spleen and stomach and detoxifies, serving as the adjuvant herbs. This formula follows the principle of "clearing heat without hindering dampness, resolving dampness without promoting heat, and detoxifying without harming the body's vital energy." It eliminates pathogens without harming the body's vital energy and supports the body's vital energy without lingering on pathogens. The whole formula works together to strengthen the spleen and clear the stomach, resolve dampness and detoxify, so that damp heat and turbid toxins are eliminated and excreted, and the stomach qi returns to its normal downward flow. Thus, symptoms can be alleviated and the progression of the disease can be prevented.

[0262] Fried Coptis chinensis is bitter and cold in nature, and enters the heart, spleen, stomach, liver, gallbladder, and large intestine meridians. Its bitterness dries dampness, and its coldness clears heat, making it particularly effective at clearing damp-heat and fire toxins from the middle jiao (middle burner). It also resolves stagnant qi and turbid toxins, making it an essential medicine for treating damp-heat fullness, vomiting, and diarrhea. After being fried, its cold nature is slightly reduced, further enhancing its bitter, drying, and consolidating power, specifically targeting the middle jiao. In this formula, Coptis chinensis is the chief herb, directly suppressing damp-heat evil in the spleen and stomach, clearing stomach fire, and resolving heat toxins. This relieves the symptoms of burning pain in the stomach, bitter taste in the mouth, and red tongue, while also eliminating the source of toxin formation. It is an essential medicine for treating damp-heat accumulating in the stomach and scorching the blood vessels, leading to toxin formation.

[0263] Evodia rutaecarpa, with a bitter and pungent taste and hot nature, enters the liver, spleen, stomach, and kidney meridians. This herb excels at warming the middle jiao and drying dampness, relieving nausea and vomiting. Although it is hot and dry in nature, when combined with Coptis chinensis, it utilizes the principle of "left-hand metal" (a concept in Traditional Chinese Medicine), using pungent herbs to open and bitter herbs to descend. This not only counteracts the bitter coldness of Coptis chinensis, preventing it from harming the middle jiao, but also guides heat downwards, soothing the liver qi. When the liver qi flows smoothly, the stomach qi naturally harmonizes, thereby harmonizing the stomach, relieving nausea and vomiting, and clearing stagnation. The combination of these two herbs regulates the balance of cold and heat, restoring the ascending and descending functions of the middle jiao.

[0264] Hedyotis diffusa, slightly bitter and sweet in taste, cold in nature, and enters the stomach, large intestine, and small intestine meridians. This herb excels at clearing heat and detoxifying, promoting diuresis and relieving strangury, and eliminating carbuncles and nodules. Its cold nature clears away the heat toxins generated from prolonged damp-heat stagnation in the spleen and stomach, while its sweet and bland taste promotes diuresis, allowing the pathogens to be expelled through urination. In formulas, it is used as an assistant herb to assist Coptis chinensis in differentiating damp-heat toxins, specifically clearing damp-heat and heat toxins accumulated in the spleen and stomach, and facilitating the expulsion of dampness. It is used for cases of damp-heat with toxicity, characterized by redness, swelling, erosion, or even intestinal metaplasia of the gastric mucosa, effectively clearing away turbid toxins and preventing malignant transformation.

[0265] Fragrant tea herb, bitter and slightly pungent in taste, cool in nature, and enters the liver, stomach, and lung meridians. This herb has the effects of clearing heat and detoxifying, promoting blood circulation and reducing swelling, and promoting diuresis and harmonizing the stomach. It can "clear heat and toxins, eliminate dampness and stagnation, and relieve pain." Its heat-clearing and detoxifying effects are similar to those of Oldenlandia diffusa, but it also enters the blood level, dispersing blood stasis and reducing swelling, detoxifying and promoting circulation. Its slightly pungent nature also has the ability to disperse stagnation. Its pungent and bitter properties can clear damp-heat in the middle jiao and disperse blood stasis, making it particularly suitable for stomach distension, fullness, and discomfort caused by the mutual accumulation of damp-heat and blood stasis. This herb can not only synergistically clear heat, resolve dampness, and detoxify, but also promote blood circulation to dredge the stomach meridians, improve local qi and blood stagnation, eliminate phlegm and blood stasis, and relieve fixed stabbing or burning pain in the stomach, reflecting the principle of treating the meridians while detoxifying. In this formula, it is used as an assistant herb to enhance the effects of clearing damp-heat, detoxifying, and promoting circulation.

[0266] Calcined oyster shell, salty in taste and neutral in nature, enters the lung, stomach, and liver meridians. When calcined, it neutralizes stomach acid, relieves pain, resolves phlegm, and softens hardened masses. It can neutralize stomach acid, alleviate acid reflux, and dissolve lumps caused by phlegm and blood stasis, while also protecting the lining and promoting tissue regeneration. In this formula, it is not used primarily for its phlegm-resolving and mass-dissolving effects, but rather for its specialized ability to neutralize stomach acid and protect the lining, directly targeting the main symptoms of stomach discomfort, acid reflux, and vomiting; it is a key medicine for treating the symptoms.

[0267] Calcined oyster shell, salty and astringent in taste, slightly cold in nature, enters the liver, gallbladder, and kidney meridians. After calcination, its astringent and consolidating properties are greatly enhanced, making it excellent at neutralizing acid and relieving pain, astringing and consolidating, and also softening and dispersing nodules. Its heavy weight has a calming effect; its salty taste softens, and its slightly cold nature clears heat. In this formula, it is used synergistically with calcined oyster shell to enhance its acid-neutralizing, gastric mucosal-protecting, stomach-soothing, and lumpy-dispersing effects. Simultaneously, its slightly cold nature assists in clearing heat, its calming effect addresses emotional well-being, and its astringent properties help repair damaged gastric mucosa.

[0268] Albizia bark, sweet in taste and neutral in nature, enters the heart, liver, and lung meridians. It excels at relieving depression, calming the mind, promoting blood circulation, and reducing swelling. Chronic gastritis is often closely related to emotional distress and liver qi invading the stomach; prolonged damp-heat and toxic stagnation can also disturb the mind. The addition of Albizia bark to this formula serves several purposes: first, it relieves liver stagnation and regulates emotions, alleviating the weakening effect of the "wood" element on the "earth" element, thus helping the spleen and stomach's qi to return to its normal rising and falling state; second, its blood-activating effect helps to clear the stomach meridians; and third, it calms the mind and improves accompanying symptoms such as anxiety and insomnia, embodying the concept of "treating both body and mind."

[0269] Roasted malt is sweet in taste and neutral in nature, entering the spleen, stomach, and liver meridians. It excels at aiding digestion, resolving food stagnation, regulating qi, and harmonizing the middle jiao, especially effective in eliminating food stagnation caused by rice, noodles, potatoes, and taro. Roasting enhances its aroma and strengthens its ability to invigorate the spleen and stimulate appetite, while maintaining its neutral nature. In this formula, it serves two purposes: firstly, it addresses poor appetite by eliminating food stagnation and promoting digestion; secondly, amidst a large group of cooling and clearing herbs, it subtly promotes digestion, preventing stagnation in the stomach and maintaining the proper functioning of the middle jiao, embodying the principle of "treating the stomach without forgetting to regulate the spleen."

[0270] Poria cocos, sweet and bland in taste, neutral in nature, enters the heart, lung, spleen, and kidney meridians. This herb, sweet and bland in taste, promotes diuresis and eliminates dampness, strengthens the spleen, calms the mind, and eliminates urination. Its spleen-strengthening effect helps the spleen and stomach restore their function of transporting and transforming dampness, thus eliminating the source of dampness regeneration; its dampness-eliminating effect guides damp-heat in the middle jiao (middle burner) slowly out through urination, providing an outlet for the pathogen, as the saying goes, "Treatment for dampness without promoting urination is not the proper treatment." This herb strengthens the spleen, eliminates dampness, calms the mind, and soothes the nerves. Its mild diuretic properties guide damp-heat downwards, while its spleen-strengthening and qi-tonifying effects consolidate the middle jiao, allowing the spleen and stomach to recover naturally after dampness is eliminated, leaving no place for toxins to reside. In this formula, it strengthens the spleen, eliminates dampness, calms the mind, and stabilizes the spirit, ensuring that the clearing of damp-heat does not harm the spleen, and that it detoxifies, harmonizes the stomach, and calms the mind.

[0271] Prepared licorice root, sweet in taste and neutral in nature, enters the heart, lung, spleen, and stomach meridians. This formula utilizes several of its properties: First, its sweet and mild nature harmonizes the middle jiao, relieving spasms and pain, specifically targeting stomach cramps and pain; second, it harmonizes other herbs, mitigating the extreme properties of Coptis chinensis and Evodia rutaecarpa, and balancing the cold, hot, bitter, and pungent nature of the herbs, ensuring their combined effect without hindrance; third, it tonifies qi and strengthens the middle jiao, protecting the spleen and stomach's vital energy while clearing and purging, ensuring that the elimination of pathogens does not harm the body's constitution; fourth, it also possesses heat-clearing and detoxifying properties, aiding in the detoxification process. The entire formula leverages its sweet and neutral properties to harmonize the cold, hot, ascending, and descending nature of the herbs, achieving a balanced and moderate effect in clearing and detoxifying.

[0272] 4. Modern Pharmacological Research on Qingwei Huadu Decoction

[0273] From the perspective of modern pharmacology, the efficacy of Qingwei Huadu Decoction is not due to the isolated action of a single component, but rather to the deep integration and synergy of its complex chemical components through multiple mechanisms, including antibacterial and anti-inflammatory effects, inhibition of gastric acid, repair of the mucosa, regulation of gastrointestinal motility, anti-abnormal proliferation, and stabilization of the neuroimmune system. This systematically intervenes in the entire pathological process of chronic gastritis, providing a solid scientific basis for the treatment principle of "strengthening the spleen and clearing the stomach, resolving dampness and detoxifying." The brilliance of the entire formula lies in the fact that stir-fried Coptis chinensis, Evodia rutaecarpa, and Hedyotis diffusa constitute the main force in eliminating the cause of the disease; calcined oyster shell, calcined oyster shell, and prepared licorice root form the defensive line of protecting the mucosa and alleviating symptoms; and stir-fried malt, Poria cocos, and Albizia julibrissin provide support from the perspective of regulating overall function. This multi-target, multi-level pharmacological action is precisely the advantage of traditional Chinese medicine decoctions in treating complex diseases.

[0274] Coptis chinensis (Huanglian): Its signature active ingredient, berberine, plays multiple key pharmacological roles. Related studies have confirmed that berberine has a clear inhibitory and killing effect on Helicobacter pylori (Hp), disrupting its biomembrane structure and inhibiting its urease activity, thereby directly eradicating the pathogenic basis of "damp-heat toxins." The anti-inflammatory mechanism of berberine significantly inhibits macrophage activation induced by lipopolysaccharide and downregulates the expression of key pro-inflammatory factors such as tumor necrosis factor-α and interleukin-1β. Its mechanism of action is closely related to the inhibition of the Toll-like receptor 4 / nuclear factor-κB signaling pathway. Furthermore, berberine can exert mild analgesic and gastric acid secretion-regulating effects by modulating transient receptor potential vanillic acid subtype 1 and other channels. It also induces apoptosis in precancerous gastric cells by regulating pathways such as B-cell lymphoma-2 / cysteine-aspartate protease family, providing pharmacological evidence for the prevention of gastritis-induced cancer.

[0275] Evodia rutaecarpa: Modern research has confirmed that the main active components of Evodia rutaecarpa, evodiamine and evodiamine alkaloid, have a bidirectional regulatory effect on gastrointestinal function. They can relieve spasms and improve insufficient motility. This mechanism is related to the regulation of the release of neurotransmitters such as serotonin and nitric oxide in the intestinal tract. This regulatory effect directly targets the core symptoms of epigastric fullness and distension. Its analgesic mechanism is independent of opioid receptors and is mainly achieved by inhibiting the production of cyclooxygenase-2 and prostaglandin E2. Evodiamine has been shown to regulate the phosphatidylinositol 3-kinase / protein kinase B signaling pathway, reducing oxidative stress damage and apoptosis of gastric mucosal cells, and synergistically exerting a protective effect on the gastric mucosa with Coptis chinensis.

[0276] Hedyotis diffusa: Its rich content of flavonoids, iridoids, and polysaccharides forms the material basis for its medicinal effects. Related studies have confirmed that quercetin and kaempferol are potent natural antioxidants and anti-inflammatory agents, capable of scavenging free radicals and inhibiting the expression of cyclooxygenase-2 and inducible nitric oxide synthase, thereby reducing inflammatory infiltration and edema of the gastric mucosa. Its polysaccharide components are powerful immune activators, promoting the function of immune cells such as macrophages and natural killer cells, and enhancing the body's ability to clear abnormal cells. Oleanolic acid and other components can directly induce tumor cell apoptosis and inhibit their invasion, which is of great significance for the prevention and treatment of precancerous lesions such as intestinal metaplasia of the gastric mucosa.

[0277] *Gynostemma pentaphyllum*: Studies have shown that blue calyx extract isolated from *Gynostemma pentaphyllum* can significantly inhibit the production of platelet-activating factor and arachidonic acid-induced thromboxane A2 synthesis, while increasing prostaglandin E2 levels. This regulatory effect on the arachidonic acid metabolic network helps improve gastric mucosal microcirculation and reduce inflammation and pain. Furthermore, *Gynostemma pentaphyllum* extract can selectively induce apoptosis in abnormally proliferating gastric mucosal cells by inducing mitochondrial dysfunction and endoplasmic reticulum stress, thus specifically targeting the development of "toxic damage to the gastric network" into tangible masses.

[0278] Calcined corrugated shell: made from the calcined shells of ark shells, its main component is calcium carbonate, with a content exceeding 90%. After calcination, it can quickly and persistently neutralize stomach acid, raising the pH value in the stomach and creating an alkaline environment for the repair of inflamed mucosa. Calcium carbonate can directly neutralize excess stomach acid, quickly relieving symptoms such as acid reflux and heartburn; this is the modern interpretation of its "acid-neutralizing and pain-relieving" effect. In addition, calcined corrugated shell is brittle, and when crushed into fine particles, it may form a physical protective film on the surface of the gastric mucosa, isolating it from further erosion by stomach acid and bile.

[0279] Calcined oyster shell: Also a calcined shellfish product, it is rich in calcium carbonate, calcium phosphate, and various trace elements. Its acid-neutralizing mechanism is similar to that of calcined corrugated iron. Modern pharmacology has discovered that oyster extract exhibits multiple effects, including anti-gastric ulcer, sedation, and immune enhancement. Its organic components, such as glycosaminoglycans, may actively participate in enhancing the defensive function of the gastric mucosal barrier. Related animal experiments have shown that oyster polysaccharides can significantly increase the secretion of gastric mucus glycoproteins, enhancing the gastric mucosal barrier; its zinc and selenium content are important cofactors of antioxidant enzymes in the body, synergistically scavenging oxygen free radicals and accelerating ulcer healing. Its sedative effect also helps relieve stomach symptoms induced by mental stress.

[0280] Albizia bark: Total saponins from Albizia bark are key to regulating the gut-brain axis and achieving synergistic treatment of the heart and stomach. Modern pharmacological studies have confirmed that triterpenoid saponins and flavonoids in Albizia bark have significant sedative and anti-anxiety effects. It can regulate the hypothalamus-pituitary-adrenal axis, reduce cortisol levels under stress, effectively regulate γ-aminobutyric acid (GABA) and serotonin levels in the brain, and improve mood disorders such as anxiety and insomnia often associated with chronic gastritis, thus breaking the vicious cycle of negative emotions aggravating stomach problems at the neuroendocrine level. Furthermore, Albizia bark extract has also been reported to have certain anti-inflammatory and fibroblast proliferation-promoting effects, which may indirectly benefit the repair of gastric mucosal tissue.

[0281] Roasted malt: Rich in digestive enzymes such as amylase and protease, as well as dietary fiber, it directly aids digestion and reduces the burden on the stomach. Its breakdown products and fiber also promote the growth of beneficial gut bacteria, thus improving the overall gastrointestinal microecology. After roasting, the amylase activity of malt is moderately reduced, while its stomach-strengthening and digestive effects are enhanced. It gently promotes the secretion of gastric juice and pepsin, strengthens gastrointestinal motility, and its rich content of digestive enzymes and B vitamins provides material support for the repair of damaged gastric mucosa and energy metabolism.

[0282] White Poria: Its core components, Poria polysaccharides and triterpenoids, play a key role. Poria polysaccharides are classic biological response modifiers with significant immunomodulatory functions. They can enhance non-specific immunity, regulate specific immune responses, and reduce immune-inflammatory damage to the gastric mucosa.

[0283] Prepared licorice root: Its core active components, glycyrrhizic acid, glycyrrhetinic acid, and glycyrrhizin flavonoids, constitute its multifunctional pharmacological basis. Glycyrrhizic acid and glycyrrhetinic acid have steroid-like anti-inflammatory effects, stabilizing cell membranes and inhibiting phospholipase A2 activity, thereby reducing the production of inflammatory mediators such as prostaglandins and leukotrienes, and synergistically controlling inflammation without the side effects of hormones. Licorice root and its extracts can directly promote the synthesis and secretion of prostaglandin E2 in the gastric mucosa. Prostaglandin E2 can inhibit gastric acid secretion, increase gastric mucosal blood flow, and promote mucus and bicarbonate secretion, acting as an endogenous gastric mucosal protectant. In addition, the "spasmodic and analgesic" effect of licorice root is related to its antispasmodic effect on smooth muscle.

[0284] 5. Basis for selecting the medication regimen in the control group

[0285] The control group received a combination of omeprazole and mosapride, a classic combination therapy for chronic gastritis that is widely used in clinical practice and has ample evidence-based support. In clinical observation, the inventors found that patients with chronic gastritis exhibiting spleen and stomach damp-heat syndrome with toxicity often presented with symptoms related to excessive gastric acid secretion, such as burning pain in the epigastrium and acid reflux, as well as gastrointestinal motility disorders such as abdominal distension and poor appetite. Therefore, they believe that the pathophysiological basis of this syndrome may be closely related to excessive gastric acid secretion and insufficient gastrointestinal motility.

[0286] The level of gastric acid secretion is not determined by the type of gastritis (whether it is atrophic or not), but rather by the location of the lesion and the residual function. In atrophic gastritis (CNAG), where the lesion is confined to the antrum while the gastric body mucosa remains functional, gastric acid secretion is often high. In contrast, in atrophic gastritis, if the atrophy only affects the antrum and the chief cells and parietal cells retain function, their acid secretion can remain normal or even exhibit compensatory hyperactivity. The degree of preservation of gastric body acid secretion function is the key factor determining gastric acid levels. When inflammation is predominantly in the antrum while gastric body function is relatively intact, regardless of whether the pathological classification is non-atrophic or atrophic, patients may exhibit normal or even compensatory hyperactivity of gastric acid secretion, leading to acid-related symptoms such as burning pain and acid reflux. Simultaneously, gastrointestinal motility disorders are widespread in chronic gastritis, manifesting as abdominal distension and loss of appetite.

[0287] Based on this, the selection of the control regimen in this application focuses on two core therapeutic targets: inhibiting excessive gastric acid secretion and improving gastrointestinal motility disorders. Omeprazole, as a PPI, irreversibly inhibits H+ / K+-ATPase in gastric parietal cells, effectively blocking gastric acid secretion and specifically relieving symptoms related to excessive gastric acid, such as burning pain and acid reflux, creating a favorable low-acid environment for gastric mucosal repair. Mosapride, as a selective serotonin 4 receptor agonist, promotes gastrointestinal motility and improves gastric emptying, specifically relieving symptoms of motility disorders such as abdominal distension and poor appetite. The combination of these two drugs precisely covers the two most prominent clinical manifestations in patients with spleen and stomach damp-heat syndrome with toxicity, achieving an organic unity of etiological intervention and symptom control. As a treatment regimen for the Western medicine control group, it is clinically representative and feasible.

[0288] This application sets the treatment course for both groups at 8 weeks, which is based on a comprehensive consideration of the clinical characteristics and symptom recurrence characteristics of this syndrome type found in previous clinical observations. It also takes into account the actual consideration of patient compliance in clinical research, and provides a reasonable time window for objectively evaluating the difference in efficacy between the two intervention programs.

[0289] (II) Analysis of Research Results

[0290] 1. Selection of efficacy evaluation system

[0291] Chronic gastritis, a common digestive system disease, presents with diverse clinical manifestations and a prolonged course, causing not only physical discomfort but also often accompanied by changes in mental and psychological state and a decline in quality of life. Therefore, a scientific, objective, and comprehensive evaluation of the treatment efficacy of chronic gastritis requires the construction of a multi-dimensional and multi-level integrated evaluation system. This application, targeting the characteristics of spleen and stomach damp-heat with toxicity syndrome in chronic gastritis, comprehensively draws upon internationally accepted scales, traditional Chinese medicine syndrome evaluation, and modern psychological assessment tools to construct a composite efficacy evaluation system that includes Western medicine symptoms, traditional Chinese medicine syndromes, psychological state, and quality of life.

[0292] (1) Western medicine efficacy evaluation system

[0293] To objectively quantify the core gastrointestinal symptoms and their severity in patients with chronic gastritis, this application uses the PAGI-SYM scale. This scale is an internationally recognized tool specifically designed for assessing symptoms of upper gastrointestinal diseases, possessing good reliability and validity. It covers multiple core symptom dimensions, including reflux, early satiety, postprandial fullness, upper abdominal pain, nausea, and vomiting, and can quantitatively reflect changes in patients' subjective symptom experience before and after treatment, making it an important indicator for evaluating the efficacy of treatment for chronic gastritis. Simultaneously, to more intuitively capture changes in the intensity of patients' self-experience of core discomfort, this application supplements the application with the VAS scale. As a simple and sensitive measurement tool, the VAS can record the dynamic changes in patients' subjective feelings in real time, serving as a valuable supplement to the aforementioned structured scales and making symptom assessment more immediate and individualized.

[0294] (2) Evaluation system for the efficacy of traditional Chinese medicine

[0295] Regarding the evaluation of TCM efficacy, this application, referring to the "Consensus on TCM Diagnosis and Treatment of Chronic Gastritis (2023)," the "Technical Guidelines for Clinical Efficacy Evaluation of New Chinese Medicine Drugs for Chronic Gastritis (Trial)," and the inventor's clinical experience summary, combined with the syndrome characteristics of spleen and stomach damp-heat with toxicity, has developed a specialized TCM syndrome scale. This scale assigns different weights to primary and secondary symptoms and performs graded scoring, achieving semi-quantitative and standardized evaluation of TCM clinical symptoms. This allows for the scientific measurement of the improvement of TCM syndromes and serves as a key basis for evaluating the targeted nature of TCM interventions.

[0296] (3) Psychological state evaluation system

[0297] The development and progression of chronic gastritis are closely related to psychological factors. Anxiety and stress are often triggering or aggravating factors. Furthermore, persistent and difficult-to-cure symptoms of chronic gastritis and the long-term chronic disease state can lead to or exacerbate emotional disorders and psychological stress in patients. This application introduces the CPSS scale to assess patients' psychological stress levels. This scale effectively assesses the degree of chronic stress experienced by an individual over a period of time, effectively reflecting the patient's overall psychological stress load, and is widely used in the psychological assessment of chronic diseases. Incorporating it into the evaluation system helps to reveal the potential role of Qingwei Huadu Decoction in improving patients' disease-related chronic psychological stress, aligning with the modern treatment concept of treating both mind and body.

[0298] (4) Quality of life evaluation system

[0299] One of the ultimate goals of treatment is to improve the patient's functional status and enhance their quality of life. For quality of life assessment, this application uses the SF-36 scale, which is widely used in the field of chronic diseases. This scale comprehensively assesses the patient's quality of life across eight dimensions: physical functioning, role-based health, bodily pain, general health, energy, social functioning, role-emotional health, and mental health. Through the SF-36 scale, the overall effectiveness of the Qingwei Huadu Decoction intervention in improving the overall functional recovery and life satisfaction of patients with chronic gastritis can be evaluated, reflecting the comprehensive benefits of the treatment.

[0300] 2. General Situation Analysis

[0301] Statistical analysis showed no significant differences in general data such as gender, age, disease duration, and CG classification between the experimental and control groups (P > 0.05), indicating good comparability of baseline data between the two groups and eliminating the interference of confounding factors on the research results, thus providing a basic guarantee for the reliability of the research results.

[0302] (1) Gender analysis

[0303] Regarding gender distribution, the 116 samples ultimately included in this application showed a relatively balanced gender distribution, with 59 male patients and 57 female patients. Subgroup analysis showed that the male-to-female ratio in the experimental group was 1.07:1, while that in the control group was 1:1. There was no statistically significant difference in gender composition between the two groups (P>0.05), maintaining good intergroup balance. This avoids differences in the underlying pathogenesis, symptom characteristics, and intervention responses due to gender differences, ensuring the fairness of the comparison of intervention effects. The balanced gender distribution characteristic of this application can be explained by considering the epidemiological patterns of chronic gastritis. From an epidemiological perspective, existing studies have shown that the male-to-female ratio of chronic gastritis in southern my country is similar, approximately 1:1. The gender composition of the subjects included in this application is highly consistent with the natural incidence characteristics of the disease in this region, suggesting that the study population accurately reflects the current gender distribution of the target disease and possesses good clinical representativeness.

[0304] (2) Age analysis

[0305] Regarding age distribution, the patients included in this application ranged in age from 23 to 76 years. The mean age of the experimental group was (54.88±10.77) years, and the mean age of the control group was (55.38±14.60) years. Statistical analysis showed no significant difference in age distribution between the two groups (P>0.05), indicating a good balance in age distribution. Epidemiological data shows that the incidence of chronic gastritis increases with age, and a previous retrospective study confirmed that patients seeking outpatient care for chronic gastritis are mainly aged 40-69 years. In this application, this age group accounted for 81.03% of the experimental group and 64.91% of the control group, a distribution highly consistent with the clinical epidemiological pattern of chronic gastritis. From the perspective of pathophysiology and traditional Chinese medicine pathogenesis, this age group is more prone to the pathogenesis of damp-heat and toxic accumulation in the spleen and stomach due to factors such as irregular diet, disordered sleep patterns, and natural decline in spleen and stomach function. Therefore, the research results have greater clinical reference value. Furthermore, middle-aged and elderly patients often exhibit physiological characteristics such as reduced gastrointestinal mucosal repair capacity and altered pharmacokinetics, while the onset of disease in younger patients is often closely related to unhealthy lifestyles. This application ensures a balanced age distribution between the two groups and across age groups, effectively eliminating confounding factors such as age-related physiological status, differences in underlying diseases, and drug metabolism capacity from influencing the intervention effect, thus ensuring the scientific rigor and objectivity of the inter-group efficacy comparison.

[0306] (3) Analysis of the course of the disease

[0307] This application included patients with disease durations ranging from 0.3 years to 10 years. The average disease duration in the experimental group was (2.75±1.86) years, and in the control group it was (2.51±1.80) years. An independent samples t-test showed no statistically significant difference in disease duration between the two groups (P>0.05), and the distribution of disease durations across different stages was balanced. The duration of chronic gastritis is closely related to the severity of gastrointestinal mucosal lesions and the persistence of symptoms. The longer the disease duration, the more likely the mucosal damage is to persist and heal, the more likely clinical symptoms are to recur, and the more difficult the intervention becomes. This application ensured that the baseline disease durations of the two groups were consistent, effectively avoiding interference from differences in the underlying gastrointestinal mucosal lesions, the complexity of the pathogenesis, and the severity of the disease caused by variations in disease duration. This ensured the scientific validity and reliability of the comparison of the efficacy of the two intervention regimens for chronic gastritis at different disease durations.

[0308] (4) CG subtyping analysis

[0309] According to the "Technical Guidelines for Clinical Efficacy Evaluation of New Traditional Chinese Medicines for Chronic Gastritis (Trial Implementation)," if patients with both CAG and CNAG are to be included, it is recommended that the proportion of CAG patients be no less than 40%. This application included 116 patients with chronic gastritis, of whom 37 were CAG patients (63.8%) in the experimental group and 32 were CAG patients (55.2%) in the control group, meeting the research criteria. Chi-square test showed no statistically significant difference in the CG subtype distribution between the two groups (P>0.05), indicating that the two groups had a balanced distribution of pathological subtypes and comparable baseline pathological characteristics. Clinical pathological studies have shown significant differences between CAG and CNAG in pathological mechanisms, the degree of gastrointestinal mucosal damage, and clinical prognosis. CAG, due to gastric mucosal gland atrophy and impaired barrier function, exhibits more persistent and refractory clinical symptoms and is accompanied by a higher risk of intestinal metaplasia and dysplasia, requiring more effective interventions and presenting with greater treatment difficulty. The baseline levels of pathological classification in the two groups of patients in this application are balanced, which effectively eliminates the interference of differences in the degree of mucosal damage, the risk of disease progression, and the difference in intervention response caused by differences in pathological classification on the research results. This ensures the scientific rigor and accuracy of the comparison of the efficacy of the two interventions in different pathological types of chronic gastritis. At the same time, it provides a reliable baseline basis for the application of this formula to the spleen and stomach damp-heat syndrome with toxicity in different pathological stages of chronic gastritis.

[0310] (5) Analysis of causal factors

[0311] Regarding the distribution characteristics of precipitating factors, this application compared the core precipitating factors such as smoking, alcohol consumption, work and rest habits, and dietary habits between the two groups of patients. The results showed no statistically significant differences in the composition ratio of each precipitating factor (P>0.05), and the baselines between the groups were well balanced. Both modern medicine and traditional Chinese medicine theories have confirmed that factors such as smoking and alcohol consumption can directly damage the gastric mucosal barrier function; long-term consumption of rich and fatty foods easily leads to dysfunction of spleen and stomach transportation and transformation, and internal accumulation of damp-heat; while irregular work and rest and overwork further cause imbalance of spleen and stomach qi. The above-mentioned precipitating factors are key risk factors for the occurrence and development of chronic gastritis, and are closely related to the core pathogenesis of spleen and stomach damp-heat with toxicity syndrome in this application. The balanced distribution of precipitating factors between the two groups of patients in this application effectively eliminated the interference of heterogeneity in the severity, duration, and intervention response caused by differences in lifestyle habits and precipitating factors on the study outcome, further ensuring the consistency of the baseline characteristics of the two groups and the reliability of the study results.

[0312] Comparative Analysis of PAGI-SYM Scores

[0313] The PAGI-SYM score is a specialized scale for assessing upper gastrointestinal symptoms. It effectively quantifies the severity of core clinical symptoms of chronic gastritis, such as upper abdominal pain, bloating, and belching, and is an important standardized indicator for evaluating the efficacy of interventions for upper gastrointestinal symptoms in clinical practice. The results of this application show that there was no statistically significant difference in the total PAGI-SYM score between the experimental group and the control group before treatment (P>0.05), indicating baseline comparability. After 8 weeks of treatment, the scores in both groups were significantly lower than before treatment (P<0.05), and the score in the experimental group (10.81±4.12) was significantly lower than that in the control group (19.55±3.11) (p<0.05). This result indicates that both intervention programs effectively improved the core clinical symptoms of patients with chronic gastritis, but the Qingwei Huadu Decoction showed superior symptom improvement.

[0314] From a physiological and pathological perspective, the core symptoms of chronic gastritis, such as upper abdominal burning pain, bloating, and heartburn, are closely related to abnormal gastric acid secretion, gastrointestinal motility disorders, and gastric mucosal inflammation. These indicators are the most direct clinical manifestations of chronic gastritis and are also the main targets for symptomatic treatment in modern medicine. The control group received the classic regimen of omeprazole combined with mosapride. Omeprazole, as a proton pump inhibitor, can reduce gastric acid secretion at its source by inhibiting the activity of H+-K+-ATPase in gastric parietal cells, thus quickly relieving the burning pain in the stomach caused by gastric acid irritating the gastric mucosa. Mosapride, as a prokinetic drug, can promote the contraction of gastrointestinal smooth muscle, accelerate gastric emptying, and improve discomfort such as bloating and belching caused by insufficient gastrointestinal motility. Therefore, the scores after treatment with this regimen were significantly improved compared to before treatment. However, this combined approach essentially treats the symptoms of "excessive gastric acid secretion and gastrointestinal motility disorders," providing only temporary relief without addressing the core pathogenesis of chronic gastritis or regulating the patient's overall physiological state. It is therefore insufficient to fundamentally reverse gastric mucosal inflammation and spleen-stomach dysfunction. In contrast, the Qingwei Huadu Decoction targets the core pathogenesis of damp-heat syndrome in the spleen and stomach. The formula contains stir-fried Coptis chinensis and Evodia rutaecarpa, which clear damp-heat from the spleen and stomach while simultaneously harmonizing the spleen and stomach's Qi, quickly relieving symptoms such as burning pain in the stomach. Hedyotis diffusa and Evodia rutaecarpa clear heat, detoxify, cool the blood, and reduce swelling, effectively eliminating toxins and repairing the damaged gastric mucosal barrier, reducing the continuous damage to the gastric mucosa caused by inflammation. Calcined oyster shell and calcined oyster shell, with their sinking properties, neutralize acid, relieve pain, soften and disperse nodules, further alleviating discomfort caused by excessive gastric acid and aiding in gastric mucosal repair. The combined use of these drugs addresses both the symptoms and the root cause. They quickly relieve superficial symptoms such as burning pain in the stomach and abdominal distension by neutralizing acid and regulating qi, while fundamentally improving the inflammatory state of the gastrointestinal mucosa by strengthening the spleen and clearing the stomach, resolving dampness and detoxifying. This regulates the qi mechanism of the spleen and stomach and repairs their function. Therefore, the improvement of the core symptoms of chronic gastritis is more thorough and significant, which is the core reason why the PAGI-SYM score of the experimental group was significantly lower than that of the control group.

[0315] 3. Comparative Analysis of SF-36 Ratings

[0316] The SF-36 scale comprehensively evaluates patients' physical and mental state and social adaptability across eight dimensions: PF, RP, BP, GH, VT, SF, RE, and MH, aligning with the modern medical treatment goal of "improving quality of life as the core of disease treatment." The results of this application show that before treatment, there were no statistically significant differences in the scores of each dimension of the SF-36 between the two groups (P > 0.05), indicating comparable baselines. After treatment, the scores of each dimension in both groups significantly improved compared to before treatment (P < 0.05), and the scores of each dimension in the experimental group were significantly higher than those in the control group (P < 0.05).

[0317] From the perspective of the physiological-psychological-social medical model, patients with chronic gastritis and spleen-stomach damp-heat syndrome suffer from long-term physical symptoms such as burning pain in the stomach, abdominal distension, bitter taste in the mouth, and halitosis. On the one hand, this directly leads to a decline in physiological function, manifested as reduced exercise tolerance, limited daily activities, and recurring physical pain, which in turn affects physiological functions and general health. On the other hand, due to the lingering and recurring symptoms, patients are prone to negative psychological emotions such as anxiety, irritability, and depression, which in turn lead to social avoidance, emotional apathy, and a gradual loss of social confidence, forming a vicious cycle of "physical symptoms - psychological disorders - declining quality of life." This is the core reason why the quality of life of such patients is generally low.

[0318] The control group received a treatment regimen of omeprazole combined with mosapride. While this regimen could alleviate some physical symptoms by inhibiting gastric acid secretion and improving gastrointestinal motility, thus reducing patients' physical discomfort to some extent, it only focused on symptomatic treatment of physical symptoms and did not address the accompanying psychological state and social functioning. The limited symptom improvement resulted in a limited effect on improving quality of life. In contrast, the Qingwei Huadu Decoction, based on strengthening the spleen and clearing the stomach, resolving dampness and detoxifying, also addresses the regulation of spleen and stomach function and emotional relief. It not only significantly improves physical symptoms to eliminate the physiological root causes of declining quality of life, but also alleviates patients' anxiety, irritability, and other negative emotions by strengthening the spleen and clearing the stomach, calming the mind and soothing the nerves, thereby improving energy levels and social functioning. While significantly alleviating clinical physical symptoms, it also more effectively improved patients' psychological state, enhanced their social confidence, and reduced the impact of the disease on their daily life, work, and social interactions. Ultimately, it achieved a virtuous cycle of "improvement of physical symptoms - adjustment of psychological state - comprehensive improvement of quality of life." This is the core mechanism by which the scores of each dimension of the SF-36 scale in the experimental group were significantly higher than those in the control group, further highlighting the overall advantages of Qingwei Huadu Decoction in treating chronic gastritis with spleen and stomach damp-heat and toxicity syndrome.

[0319] 4. Comparative Analysis of VAS Scores

[0320] The VAS score is a classic method for quantifying subjective perception of somatic symptoms. It can directly reflect the severity of symptoms in patients with chronic gastritis, and changes in the score directly correspond to improvements in the patient's subjective perception of physical discomfort, making it an important quantitative indicator for evaluating clinical efficacy. The results of this application show that before treatment, there was no statistically significant difference in VAS scores between the experimental group (5.16±0.57) and the control group (5.12±0.36) (P>0.05), indicating baseline comparability. After treatment, the scores in both groups were significantly lower than before treatment (P<0.05), indicating that both interventions effectively alleviated the patient's physical discomfort. Furthermore, the experimental group (1.76±0.64) had a significantly lower score than the control group (3.50±0.45) (P<0.05), fully demonstrating that the Qingwei Huadu Decoction is significantly more effective than the control group in alleviating the patient's subjective perception of somatic symptoms.

[0321] From the perspective of patients' subjective experience, the VAS score is directly related to patients' quality of life and confidence in treatment. Patients with chronic gastritis often experience recurring physical symptoms such as stomach discomfort and dull pain, which are often accompanied by eating habits and mood swings. Prolonged subjective discomfort can easily lead to negative emotions such as anxiety and irritability, further aggravating the sensitivity of bodily perception. This is a key reason why these patients experience recurring physical symptoms and intense subjective discomfort. Omeprazole's mechanism of action primarily focuses on inhibiting gastric acid secretion, thereby reducing the chemical stimulation of the gastric mucosa by gastric acid and alleviating some acid-related physical symptoms. However, this effect is limited to symptomatic relief and has no significant effect on mucosal inflammation, smooth muscle spasms, and visceral hypersensitivity caused by damp-heat accumulation and toxic obstruction. Therefore, its effect on relieving the overall subjective physical discomfort of patients is limited. Qingwei Huadu Decoction targets the underlying pathogenesis of damp-heat with toxicity, employing the principles of "strengthening the spleen and clearing the stomach, resolving dampness and detoxifying." It inhibits gastric acid secretion, relieves gastrointestinal smooth muscle spasms, reduces mucosal inflammation, and lowers visceral hypersensitivity. Its significant improvement in VAS scores not only reflects objective relief of physical discomfort but also signifies a reduction in subjective suffering and a restoration of control over one's life. When patients experience a decrease in their subjective perception of stomach discomfort, their daily activities, such as eating and sleeping, are less affected, and negative emotions are alleviated. This synergistic improvement in mind and body is difficult to achieve with simple acid-suppressing treatment; therefore, Qingwei Huadu Decoction has a more significant and lasting clinical effect.

[0322] 5. Comparative Analysis of CPSS Scores

[0323] The CPSS scale focuses on an individual's subjective perception of stress, covering dimensions such as stress intensity, stress controllability, and the impact of stress on life. It can indirectly reflect the psychological stress level of patients with chronic gastritis caused by their condition. The results of this application show that there was no statistically significant difference in the total CPSS score between the experimental group and the control group before treatment (P>0.05), indicating baseline comparability. After treatment, the scores of both groups were significantly lower than before treatment (P<0.05), with the experimental group showing a significantly lower score than the control group (P<0.05). Although both groups effectively reduced CPSS scores and alleviated psychological stress and physical symptoms after treatment, the experimental group showed significantly greater improvement than the control group in core indicators reflecting the improvement in patients' perceived stress and overall disease control.

[0324] From a sociological and psychosomatic perspective, patients with chronic gastritis exhibiting spleen and stomach damp-heat syndrome often experience significant psychological stress due to recurring physical symptoms such as stomach pain, bloating, and acid reflux. This persistent stress perception, in turn, exacerbates spleen and stomach qi imbalances and the accumulation of damp-heat toxins through abnormal brain-gut axis regulation, creating a vicious cycle of "physical symptoms - psychological stress." Therefore, the perceived stress assessed by the CPSS is a crucial factor influencing the quality of life and prognosis of patients with chronic gastritis. The recurrent flare-ups of chronic gastritis and the distress caused by physical symptoms lead to persistent psychological stress, which not only triggers negative emotions such as anxiety and irritability but also interferes with normal eating, sleeping, working, and social activities, further aggravating spleen and stomach dysfunction and creating a vicious cycle.

[0325] Omeprazole combined with mosapride focuses only on two single aspects: gastric acid secretion inhibition and gastrointestinal motility regulation. It has no significant effect on core pathological changes such as damp-heat accumulation, spleen and stomach qi stagnation, and mucosal inflammation repair, and also fails to address the psychological stress caused by recurring symptoms. In clinical trials, this symptomatic treatment, while temporarily relieving some superficial physical symptoms such as acid reflux and bloating, has limited effect on improving stress perception, leading to persistent stress and recurring symptoms easily triggered by stress. This results in unstable disease control and ultimately a limited decrease in CPSS scores, making long-term effective disease control difficult. In contrast, Qingwei Huadu Decoction follows the holistic concept and syndrome differentiation principles of Traditional Chinese Medicine, precisely targeting the core pathogenesis of damp-heat with toxicity in the spleen and stomach. It also considers both physical and mental well-being, employing a comprehensive treatment approach of "strengthening the spleen and clearing the stomach, resolving dampness and detoxifying," intervening in the pathological process of the disease and the patient's psychological stress state at multiple targets and stages. It not only quickly relieves clinical physical symptoms such as stomach pain, bloating, and acid reflux through its heat-clearing, dampness-resolving, qi-regulating, and stomach-soothing effects, reducing the psychological impact of physical discomfort, but also fundamentally eliminates damp-heat toxins from the body through its detoxifying, membrane-protecting, spleen-strengthening, and stomach-soothing effects. This regulates the spleen and stomach's qi mechanism, repairs damaged gastrointestinal mucosa, improves the inflammatory state of the gastrointestinal mucosa, and enhances the spleen and stomach's digestive function, thus blocking the pathological basis for recurring symptoms and reducing the psychological stress caused by recurring illness. Simultaneously, the traditional Chinese medicine treatment of "strengthening the spleen and stomach" can indirectly regulate the body's qi and blood circulation, improve emotional state, reduce the patient's perceived stress level, and break the vicious cycle of "physical symptoms - psychological stress." This comprehensive treatment strategy, addressing both the symptoms and the root cause, and the mind and body simultaneously, achieves comprehensive control of the physical symptoms of chronic gastritis with spleen and stomach damp-heat and toxin syndrome, while also effectively improving the patient's perceived stress. Therefore, the improvement in the CPSS score of the experimental group was significantly better than that of the control group.

[0326] 6. Comparative Analysis of the Efficacy of Traditional Chinese Medicine

[0327] This application evaluates the efficacy of the intervention program from three dimensions: total TCM syndrome score, individual TCM syndrome scores, and overall TCM efficacy. The results show that the efficacy of Qingwei Huadu Decoction is significantly better than that of Western medicine treatment, and there is no statistically significant difference in the baseline TCM syndrome scores between the two groups (P>0.05), ensuring the reliability of the efficacy comparison.

[0328] (1) Comparative analysis of the scores of various TCM syndromes

[0329] From the inter-group comparison, after treatment, the experimental group had significantly lower scores than the control group in all eight TCM symptom categories: epigastric discomfort and burning pain, loose stools, heaviness in the body, stomach discomfort, abdominal distension, bitter taste in the mouth and halitosis, poor appetite, and mental fatigue (P < 0.05). Only the score for acid reflux and belching showed no statistically significant difference (P > 0.05). This result suggests that Qingwei Huadu Decoction has a significant ameliorative effect on most typical TCM symptoms of spleen and stomach damp-heat with toxicity syndrome. Its syndrome differentiation and treatment are more in line with the TCM syndrome characteristics of the patients included in this application and can more effectively improve the patients' clinical symptoms. Although acid reflux and belching are related to spleen and stomach damp-heat and qi stagnation, they are also directly related to excessive gastric acid secretion and gastroesophageal reflux. Omeprazole in the control group can effectively inhibit gastric acid secretion and is targeted in relieving acid reflux and belching. Therefore, there was no significant difference between the two groups in this symptom. Symptoms such as epigastric fullness and burning pain, loose stools, bitter taste in the mouth and bad breath are the core symptoms of spleen and stomach damp-heat with toxicity syndrome, which are closely related to the accumulation of damp-heat toxicity and the abnormal functioning of the spleen and stomach. Qingwei Huadu Decoction can effectively correct the above symptoms from the pathogenesis level by strengthening the spleen and clearing the stomach, resolving dampness and detoxifying, and regulating the flow of qi. The control group did not have the corresponding conditioning effect. Therefore, the experimental group has a significant advantage in improving these symptoms.

[0330] Comparative analysis within the groups showed that while the control group exhibited significant efficacy in treating seven symptoms (epigastric discomfort and burning pain, loose stools, heaviness in the body, stomach upset, acid reflux and belching, abdominal distension, and poor appetite) (P<0.05), it showed little improvement in bitter taste in the mouth, halitosis, and fatigue (P>0.05). This result reveals a misalignment between the target of Western medicine and the pathogenesis in Traditional Chinese Medicine (TCM). Bitter taste in the mouth and halitosis are essentially caused by the upward flow of damp-heat and turbid toxins, and Western acid-suppressing treatment cannot neutralize bile reflux or eliminate *Helicobacter pylori* (Hp). Fatigue stems from dampness trapping the spleen and the failure of clear yang to ascend, while acid-suppressing drugs have no direct effect on nutrient absorption, inflammatory factors, or nerve regulation, thus proving ineffective in addressing these two core symptoms. In contrast, the Qingwei Huadu Decoction, through clearing heat and dampness, detoxifying and strengthening the spleen, and regulating qi, can comprehensively correct a series of symptoms such as epigastric discomfort and burning pain and loose stools caused by the accumulation of damp-heat and toxic toxins at the pathogenesis level, demonstrating an irreplaceable advantage in supporting the body's resistance and eliminating pathogenic factors.

[0331] (2) Overall efficacy analysis of traditional Chinese medicine

[0332] After treatment, the total TCM syndrome scores of both groups were significantly lower than before treatment (P<0.05), and the experimental group was significantly lower than the control group (P<0.05), indicating that both intervention programs can effectively improve the overall TCM syndrome of patients with chronic gastritis, but the experimental group showed better overall improvement. The total effective rate of TCM syndrome in the experimental group was 91.38%, significantly higher than 70.69% in the control group (p<0.05). Among them, 36 cases in the experimental group showed significant improvement, accounting for 62.07%, while only 5 cases in the control group showed significant improvement, accounting for 8.62%, indicating that the TCM clinical efficacy of the intervention program in the experimental group was more significant. Qingwei Huadu Decoction targets the pathogenesis of spleen and stomach damp-heat with toxicity syndrome, with "strengthening the spleen and clearing the stomach, resolving dampness and detoxifying" as its core. It eliminates pathogens without harming the body's vital energy, and supports the body's vital energy without retaining pathogens. It can fundamentally improve the syndrome nature of spleen and stomach damp-heat with toxicity syndrome, thus the total syndrome score decreased more significantly.

[0333] 7. Comparative analysis of recurrence rates

[0334] Recurrence rate is an important indicator for evaluating the long-term efficacy of intervention programs. Chronic gastritis is characterized by its protracted and recurrent nature, making long-term efficacy a crucial factor in clinical intervention. This study followed up patients who responded to treatment for 4 weeks. Results showed that 53 patients in the experimental group were successfully followed up, with a recurrence rate of 9.43%, while 38 patients in the control group were successfully followed up, with a recurrence rate of 44.74%. The difference in recurrence rates between the two groups was statistically significant (P < 0.05), suggesting that Qingwei Huadu Decoction can effectively reduce the recurrence rate of chronic gastritis with spleen and stomach damp-heat and toxicity syndrome, and its long-term efficacy is significantly better than that of Western medicine treatment. Omeprazole combined with mosapride is a symptomatic treatment that can only temporarily relieve clinical symptoms, but it does not eliminate the root cause of spleen and stomach damp-heat and toxicity, nor does it regulate the overall function of the spleen and stomach. After discontinuing the medication, symptoms are very likely to recur if stimulated by dietary or lifestyle factors. The Qingwei Huadu Decoction follows the principle of "treating both the symptoms and the root cause." While strengthening the spleen and clearing the stomach, resolving dampness and detoxifying, it is combined with spleen-strengthening and stomach-harmonizing herbs such as Poria cocos, roasted malt, and prepared licorice root to protect the spleen and stomach's vital energy. On the one hand, it can thoroughly remove residual pathogens from the body, eliminating the internal root cause of disease recurrence; on the other hand, by strengthening the spleen and stomach, it improves the digestive and defensive functions of the spleen and stomach, enhancing the patient's tolerance to external triggers such as diet and lifestyle, reducing the possibility of pathogens invading again. Therefore, it can effectively reduce the recurrence rate and achieve long-term control of chronic gastritis.

[0335] 8. Safety Comparison Analysis

[0336] During the 8-week clinical observation period, no adverse events were observed in any of the patients included in this application, indicating that the intervention regimens in both the experimental and control groups had good clinical safety and no obvious toxic side effects. Patients with chronic gastritis often require long-term treatment, and good safety is a prerequisite for the clinical application of the intervention regimen. The drugs used in Qingwei Huadu Decoction are all commonly used traditional Chinese medicines in clinical practice, with strict dosage and reasonable compatibility. Furthermore, modern pharmacological studies have confirmed that the drugs used in Qingwei Huadu Decoction do not significantly damage liver and kidney function. The results of this application confirm that Qingwei Huadu Decoction has good safety in clinical application and no obvious adverse reactions, providing important safety evidence for its clinical promotion and application.

[0337] The foregoing description of embodiments of the present invention, through which those skilled in the art are able to implement or use the present invention, will be readily apparent to those skilled in the art. Various modifications to these embodiments will be readily apparent to those skilled in the art. The general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the present invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novelty disclosed herein.

Claims

1. A traditional Chinese medicine composition for improving symptoms related to damp-heat and toxicity syndrome in the spleen and stomach of chronic gastritis, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 4-8 parts of stir-fried Coptis chinensis, 1-5 parts of Evodia rutaecarpa, 20-40 parts of Hedyotis diffusa, 20-40 parts of fragrant tea leaves, 20-40 parts of calcined oyster shell, 20-40 parts of calcined oyster shell, 10-20 parts of Poria cocos, 10-20 parts of Albizia julibrissin bark, 10-20 parts of stir-fried malt, and 4-8 parts of prepared licorice root. The weight ratio of stir-fried Coptis chinensis to Evodia rutaecarpa is 1.5-2.5:1, and the ratio of the total weight of Hedyotis diffusa and Evodia rutaecarpa and the total weight of calcined oyster shell to calcined oyster shell is 0.8-1.2:

1.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 5-7 parts of stir-fried Coptis chinensis, 2-4 parts of Evodia rutaecarpa, 28-32 parts of Hedyotis diffusa, 28-32 parts of Evodia rutaecarpa, 28-32 parts of calcined oyster shell, 28-32 parts of calcined oyster shell, 14-16 parts of Poria cocos, 14-16 parts of Albizia julibrissin bark, 14-16 parts of stir-fried malt, and 5-7 parts of prepared licorice root. Among them, the weight ratio of stir-fried Coptis chinensis to Evodia rutaecarpa is 1.8-2.2:1, the weight ratio of Hedyotis diffusa to Evodia rutaecarpa is 0.9-1.1:1, the weight ratio of calcined oyster shell to calcined oyster shell is 0.9-1.1:1, and the weight ratio of Poria cocos, Albizia julibrissin bark to stir-fried malt is 0.9-1.1:0.9-1.1:0.9-1.

1.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 6 parts of stir-fried Coptis chinensis, 3 parts of Evodia rutaecarpa, 30 parts of Hedyotis diffusa, 30 parts of fragrant tea vegetable, 30 parts of calcined oyster shell, 30 parts of calcined oyster shell, 15 parts of Poria cocos, 15 parts of Albizia julibrissin bark, 15 parts of stir-fried malt, and 6 parts of prepared licorice root.

4. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The particle size of both the calcined corrugated iron and the calcined oyster shell is 10-80 mesh.

5. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The traditional Chinese medicine composition is a decoction, concentrated liquid, extract, dry extract powder, granules, capsules, tablets, pills, mixture, oral liquid or powder.

6. A method for preparing a traditional Chinese medicine composition according to any one of claims 1-5, characterized in that, Includes the following steps: S1. Weigh out the following ingredients according to the specified proportions: stir-fried Coptis chinensis, Evodia rutaecarpa, Hedyotis diffusa, Rhizoma Citri Reticulatae, calcined Ostreae Concha, calcined Ostrea gigas, Poria cocos, Albizia julibrissin bark, stir-fried malt, and prepared licorice root. S2. First decoct calcined oyster shell and calcined oyster shell with water to obtain the first decoction system; S3. Add stir-fried Coptis chinensis, Evodia rutaecarpa, Hedyotis diffusa, Rhizoma Cimicifugae, Poria cocos, Albizia julibrissin, stir-fried malt and prepared licorice to the first decoction system, continue to decoct, and filter to obtain the first filtrate. S4. Add water to the filter residue again and boil it, then filter to obtain the second filtrate; S5. Combine the first and second filtrates, concentrate, and obtain the aqueous extract or decoction of the traditional Chinese medicine composition.

7. The preparation method according to claim 6, characterized in that, In step S2, the amount of water added is 6-12 times the total weight of calcined oyster shell and calcined oyster shell, and the decoction time is 10-30 minutes. And / or, in step S3, continue simmering for 30-90 minutes; And / or, in step S4, the second simmering time is 20-60 minutes; And / or, in step S5, the combined filtrate is concentrated to 350-450 mL per dose and divided into two bags, each containing 175-225 mL.

8. The use of the traditional Chinese medicine composition according to any one of claims 1-5 in the preparation of a medicament for improving symptoms related to spleen and stomach damp-heat syndrome in chronic gastritis, wherein the related symptoms include one or more of the following: recurrent epigastric fullness or burning pain, loose stools, heaviness of the body, stomach discomfort, abdominal distension, bitter taste in the mouth and halitosis, poor appetite or mental fatigue.

9. The use according to claim 8, characterized in that, The main symptoms are recurrent epigastric discomfort or burning pain, loose stools, and general heaviness; the secondary symptoms are stomach discomfort, acid reflux and belching, abdominal distension, bitter taste in the mouth and bad breath, poor appetite and lethargy; combined with a red or purplish-red tongue, a yellow and greasy tongue coating, pale purple and dark sublingual veins, and a slippery or rapid pulse.

10. The use according to claim 8, characterized in that, The drug is used to prepare a drug that improves the severity of upper gastrointestinal symptoms, TCM syndrome scores, subjective discomfort, psychological stress, or the risk of symptom recurrence after drug withdrawal in patients with chronic atrophic gastritis or chronic non-atrophic gastritis with spleen and stomach damp-heat and toxicity syndrome.

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