Traditional chinese medicine composition for treating atopic dermatitis

Abstract

Disclosed is a traditional Chinese medicine composition for treating skin diseases. The traditional Chinese medicine composition is prepared from Coptis chinensis, Rehmanniae Radix (raw), Gardenia jasminoides, hawthorn fruits, Massa Medicata Fermentata, Uncaria rhynchophylla, Portulaca oleracea, Atractylodes lancea, Lonicera japonica, Paeonia lactiflora, ‌Folium Isatidis‌, Hordei Fructus Germinatus, Dictamnus dasycarpus, Ostreae Concha (raw), Scutellaria baicalensis, Lophatherum gracile, Aurantii Fructus Immaturus, Raphani Semen, and Arecae Semen. The traditional Chinese medicine composition takes the core treatment principle of "tonifying the kidney, clearing heart-heat, removing food stagnation and promoting digestion". The skin diseases comprise atopic dermatitis, eczema, dermatitis, allergic dermatitis, and psoriasis. The atopic dermatitis is diagnosed as the accumulated heat syndrome of the heart and spleen.

Description

A traditional Chinese medicine composition for treating atopic dermatitis TECHNICAL FIELD

[0001] The present application belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating dermatosis. BACKGROUND

[0002] Atopic dermatitis (AD) is a common chronic inflammatory skin disease, and its basic clinical features are dry skin, obvious itching, and eczematous skin lesions, which have a serious impact on the quality of life of patients. AD has different characteristics in different age stages, and can be divided into the following four stages: infant stage, childhood stage, adolescent and adult stage, and old age stage. Infant stage (from birth to 2 years old): usually showing erythema and scales on both sides of the cheeks. The rash can spread to the scalp, neck, forehead and other parts. There can be severe exudation, and secondary changes due to scratching and rubbing. Childhood stage (2 years old to 12 years old): it can be delayed from the previous stage or directly from this stage, and is often found in the elbow fossa and popliteal fossa, wrist flexor side, eyelid, neck and other parts, usually as a mossy hard patch, with scratch marks, scab and other symptoms; adolescent and adult stage (12 years old to 60 years old): in adolescent patients, the rash is often typically found in the antecubital fossa and popliteal fossa, anterior and lateral neck, and around the eyes. Overall, the skin is significantly dry, mossy and pruritic papular rash is common. Old age stage (over 60 years old): more in elderly male patients, the rash is often more severe than in the previous stages, and even generalized, with erythroderma (Lü T, Wang H. Recognition and management of atopic dermatitis in the elderly [J]. Chinese Journal of Dermatovenereology, 2019, 33(08): 949-54). Damaged skin barrier will lead to more transdermal water loss and transdermal penetration of microorganisms and allergens, which may eventually trigger an inflammatory cascade (Baurecht H, Rühlemann M C, Rodríguez E, et al. Epidermal lipid composition, barrier integrity, and eczematous inflammation are associated with skin microbiome configuration [J]. Journal of Allergy and Clinical Immunology, 2018, 141(5): 1668-1676.e16.).

[0003] The severity of AD lesions can be quantified using a number of scoring tools, the main ones being the Eczema Area and Severity Index (EASI) and the Scoring Atopic Dermatitis (SCORAD) scales, both widely used in clinical diagnosis and clinical trials (Chopra R, Vakharia P P, Sacotte R, et al. Severity strata for Eczema Area and Severity Index (EASI), modified EASI, Scoring Atopic Dermatitis (SCORAD), objective SCORAD, Atopic Dermatitis Severity Index and body surface area in adolescents and adults with atopic dermatitis [J]. British Journal of Dermatology, 2017, 177(5): 1316-1321.). The EASI score assesses the severity of redness, thickness, scratch marks and lichenified lesions and the percentage of skin involvement in four body regions (head, trunk, arms and legs). In comparison to the EASI score, the SCORAD score combines an objective evaluation by the physician of the extent and severity of eczema lesions, calculated according to the severity of the affected skin area, redness, exudation, crusting, lichenified lesions and dryness, assessing the severity of the head and neck, arms and legs, anterior trunk, back and genitalia, respectively (Charman C R, Venn A J, Williams H, et al. Measuring Atopic Eczema Severity Visually: Which Variables Are Most Important to Patients? [J]. Archives of Dermatology, 2005, 141(9).). The score also includes 2 subjective assessments by the patient, one for sleep loss and the other for pruritus.

[0004] Atopic dermatitis (AD) is a chronic and relapsing disease that requires long-term treatment. The guideline of China suggests that the treatment should be adopted according to the severity of the disease (Chinese Medical Association Dermatology Branch Immunology Group, Atopic Dermatitis Collaboration Research Center. China's atopic dermatitis diagnosis and treatment guidelines (2020 version) [J]. Chinese Journal of Dermatology, 2020, (02): 81-8.). Mild atopic dermatitis mainly uses topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), topical phosphodiesterase-4 (PDE-4) inhibitors, etc. For moderate to severe atopic dermatitis that seriously affects the health of patients, simple topical drugs often cannot effectively control the disease, and systemic treatment is needed. Traditional systemic treatment drugs include cyclosporine, methotrexate, azathioprine, etc. In recent years, the clinical application of biological agents and Janus inhibitors has provided more effective and relatively safe options for the systemic treatment of moderate to severe AD patients. However, although there are many treatment methods for AD, many traditional methods cannot achieve satisfactory efficacy or cannot be used for a long time due to safety reasons. The common adverse reactions of cyclosporine include renal dysfunction, headache, hypertension, and hyperlipidemia, etc.; methotrexate has adverse reactions such as ulcerative stomatitis, leukopenia, hepatotoxicity, and myelosuppression; azathioprine may cause hemoglobin and leukocyte reduction and liver function damage. Dupilumab does not have enough efficacy for some patients, and other patients lose response over time (may be due to the formation of drug neutralizing antibodies) (HENDRICKS A J, LIO PA, SHI V Y. Management Recommendations for Dupilumab Partial and Non-durable Responders in Atopic Dermatitis [J]. American Journal of Clinical Dermatology, 2019, 20(4): 565-9.). In addition, its administration method is subcutaneous injection, and some patients refuse to use it because they do not want to be injected. Janus inhibitors are expensive, have strict age restrictions, and long-term use is associated with the risk of infection, cardiovascular disease, and tumors. Therefore, for AD patients, an oral treatment method with good benefits and low risk is needed.

[0005] Traditional Chinese medicine has a long history in the treatment of atopic dermatitis, but there is no such name as "atopic dermatitis" in the relevant literature of traditional Chinese medicine. It is classified and recorded as "milk tinea", "milk tinea", "four wind" and other names according to similar clinical features (Liu L, Pi J M, Li W X. Pathogenesis of atopic dermatitis and regulation of traditional Chinese medicine [J]. Time treasure of traditional Chinese medicine, 2022, 33(6): 1418-1420.). Traditional Chinese medicine believes that the main pathogenesis of AD is that the body is not resistant to the environment, and there is heat in the five internal organs, the spleen fails to transport and the heart fire is excessive, the external wind, dampness and heat evil invade the skin, and the internal and external fight each other, resulting in the disease (Chen Y H. Clinical research progress of traditional Chinese medicine in the treatment of atopic dermatitis [J]. Chinese traditional Chinese medicine modern distance education, 2023, 21(2): 200-202.). In recent years, the incidence of atopic dermatitis has been increasing, and the State Administration of Traditional Chinese Medicine points out that the treatment of this disease is similar to acute, subacute and chronic eczema, and the treatment should be based on syndrome differentiation (State Administration of Traditional Chinese Medicine. Standard for diagnosis and treatment of TCM [S]. Nanjing: Nanjing University Press, 1994: 73-75.). But in the actual clinic, the phenomenon of various types of atopic dermatitis is common, and single treatment can not get the ideal effect, so modern traditional Chinese medicine summarizes the clinical experience based on ancient literature, and combines syndrome differentiation and individual treatment to treat the disease from different aspects. SUMMARY

[0006] The application is further optimized on the basis of Zishuiqingxin drink, taking "nourishing the kidney and clearing the heart, removing accumulation and promoting stagnation" as the core principle, and providing a traditional Chinese medicine composition for treating skin diseases with less medicine, good taste, fast effect, high safety and better effect, which provides a treatment scheme for patients with atopic dermatitis with heart-spleen heat syndrome. Based on this, the application is completed.

[0007] In a first aspect, the application provides a traditional Chinese medicine composition, which is composed of the following weight parts of traditional Chinese medicine:

[0008] The monarch drug is selected from one or more of Huanglian 5-20 parts, Shengdi 5-50 parts and / or Zhizi 2-30 parts;

[0009] The ministerial drug is selected from one or more of Shanzha 5-30 parts and / or Shengqu 5-30 parts;

[0010] The auxiliary drug is selected from one or more of Gouteng 5-20 parts, Mazi Xian 10-90 parts, Cangzhu 5-30 parts, Jinyinhua 5-60 parts, Shaoyao 5-30 parts, Daqingye 5-30 parts, Maiya 5-30 parts, Baixianpi 5-30 parts, Shengmuli 5-45 parts, Huangqi 2-20 parts and / or Danzhu Ye 2-20 parts;

[0011] The assistant drug is selected from one or more of Zhike 2-30 parts, Laiwei 2-15 parts and / or Binlang 2-10 parts.

[0012] Preferably, the traditional Chinese medicine composition is made of the following weight parts of traditional Chinese medicine:

[0013] The monarch drug is selected from one or more of Huanglian 5-12 parts, Shengdi 5-30 parts and / or Zhizi 2-20 parts;

[0014] The minister drug is selected from one or more of Shanzha 5-20 parts and / or Shengqu 5-20 parts;

[0015] The assistant drug is selected from one or more of Gouteng 5-15 parts, Mashiyan 10-60 parts, Cangzhu 5-20 parts, Jinyinhua 5-40 parts, Shaoyao 5-20 parts, Daqingye 5-25 parts, Maiya 5-20 parts, Baixianpi 5-20 parts, Shengmuli 5-30 parts, Huangqi 2-12 parts and / or Danzhu ye 2-15 parts;

[0016] The messenger drug is selected from one or more of Zhike 2-20 parts, Laiqizi 2-10 parts and / or Binlang 2-8 parts.

[0017] More preferably, the traditional Chinese medicine composition is made of the following weight parts of traditional Chinese medicine:

[0018] The monarch drug is selected from one or more of Huanglian 5-10 parts, Shengdi 5-25 parts and / or Zhizi 2-10 parts;

[0019] The minister drug is selected from one or more of Shanzha 5-15 parts and / or Shengqu 5-15 parts;

[0020] The assistant drug is selected from one or more of Gouteng 5-10 parts, Mashiyan 10-30 parts, Cangzhu 5-15 parts, Jinyinhua 5-30 parts, Shaoyao 5-15 parts, Daqingye 5-20 parts, Maiya 5-15 parts, Baixianpi 5-15 parts, Shengmuli 5-20 parts, Huangqi 2-10 parts and / or Danzhu ye 2-10 parts;

[0021] The messenger drug is selected from one or more of Zhike 2-10 parts, Laiqizi 2-8 parts and / or Binlang 2-6 parts.

[0022] In some specific embodiments of the present application, the traditional Chinese medicine composition is made of the following weight parts of traditional Chinese medicine: Shengdi 5-50 parts and Zhizi 2-20 parts, Shanzha 5-30 parts, Shengqu 5-20 parts, Huangqi 2-20 parts, Danzhu ye 2-20 parts, Zhike 2-30 parts, Gouteng 5-20 parts, Mashiyan 10-90 parts and Jinyinhua 5-60 parts.

[0023] In some embodiments of the present application, the traditional Chinese medicine composition is composed of the following traditional Chinese medicines by weight: 5-50 parts of raw Rehmannia, 2-20 parts of Capejasmine, 5-30 parts of hawthorn, 5-20 parts of Chinese herb, 2-20 parts of Scutellaria, 2-20 parts of lophatherum gracile, 2-30 parts of Citrus aurantium, 5-20 parts of Uncaria, 10-90 parts of Portulaca oleracea, 5-60 parts of honeysuckle, 5-20 parts of Dictamnus dasycarpus and 2-10 parts of Areca catechu.

[0024] In some embodiments of the present application, the traditional Chinese medicine composition is composed of the following traditional Chinese medicines by weight: 5-50 parts of raw Rehmannia, 2-20 parts of Capejasmine, 5-30 parts of hawthorn, 5-20 parts of Chinese herb, 2-20 parts of Scutellaria, 2-20 parts of lophatherum gracile, 2-30 parts of Citrus aurantium, 5-20 parts of Uncaria and 10-90 parts of Portulaca oleracea.

[0025] In some embodiments of the present application, the traditional Chinese medicine composition is composed of the following traditional Chinese medicines by weight: 5-50 parts of raw Rehmannia, 2-20 parts of Capejasmine, 5-30 parts of hawthorn, 5-20 parts of Chinese herb, 2-20 parts of Scutellaria, 5-30 parts of Largeleaf Hedy s, 5-30 parts of Malt, 5-20 parts of Raphanus and 5-20 parts of Dictamnus dasycarpus.

[0026] In some embodiments of the present application, the traditional Chinese medicine composition is composed of the following traditional Chinese medicines by weight: 5-50 parts of raw Rehmannia, 2-20 parts of Capejasmine, 5-30 parts of hawthorn, 5-20 parts of Chinese herb, 2-20 parts of Scutellaria, 5-30 parts of Largeleaf Hedy s, 5-30 parts of Malt, 5-20 parts of Raphanus, 5-30 parts of Paeonia and 5-20 parts of Dictamnus dasycarpus.

[0027] In some embodiments of the present application, the traditional Chinese medicine composition is composed of the following Chinese medicines by weight: 5-50 parts of raw Rehmannia, 2 -20 parts of Capejasmine, 5-30 parts of hawthorn, 20 parts of Chinese herb, 2-20 parts of Scutellaria, 5 -30 parts of Largeleaf Hedy s, 5-30 parts of Malt, 20 parts of Raphanus, 5-30 parts of raw oyster and 5-20 parts of Uncaria.

[0028] In some embodiments of the present application, the traditional Chinese medicine composition is composed of the following medicines by weight: 5-50 parts of raw Rehmannia, 2-15 parts of Coptis, 5-30 parts of hawthorn, 5-20 parts of Chinese medicine, 5-30 parts of Atractylodes, 1-5 parts of Largeleaf Hedy s, 5-20 parts of Raphanus, 5-20 parts of Dictamnus dasycarpus and 5-30 parts of honeysuckle.

[0029] In some embodiments of the present application, the traditional Chinese medicine composition is composed of the traditional Chinese medicines by weight: 5-50 parts of raw Rehmannia, 5-30 parts of Coptis, 5-30 parts of hawthorn, 5 -20 parts of Chinese herb, 5-30 parts of Atractylodes, 1-5 parts of Large-leaf Hedy s, 5-20 parts of Raphanus, 5-20 of Dictamnus dasycarpus and 5-30 parts of raw oyster.

[0030] In a second aspect, the present application provides a traditional Chinese medicine preparation made of the traditional Chinese medicine composition of the first aspect, wherein the traditional Chinese medicine preparation is one or more of a paste, a pill, a pill, a decoction, a granule, a capsule, a powder and / or a tablet.

[0031] Further, the traditional Chinese medicine preparation is a decoction, and a preparation method of the decoction comprises the following steps:

[0032] S01: preparing traditional Chinese medicine raw materials according to a required ratio;

[0033] S02: soaking the traditional Chinese medicine raw materials prepared in S01;

[0034] S03: boiling the raw materials and the soaking liquid together for several times;

[0035] S04: combining and concentrating the medicinal liquid obtained by boiling for several times to obtain a concentrated medicinal liquid, which is the decoction of the present application.

[0036] Further, in step S02, the weight of the soaking liquid added for the first time is 8 times the total weight of the raw materials, and the soaking time is 20-30 minutes; the weight of the soaking liquid added for the second time is 6 times the total weight of the raw materials.

[0037] Further, in step S03, the boiling is first carried out with a strong fire to boil the raw materials and the soaking liquid, and then the strong fire is changed to a weak fire to continue boiling for 20-30 minutes, and the boiling is carried out for a total of 2 times.

[0038] Further, the traditional Chinese medicine preparation comprises pharmaceutically acceptable excipients required for the corresponding preparation.

[0039] Still further, the excipients are medicinal excipients that have the effects of enhancing the efficacy of the main drugs, reducing the toxicity and / or alleviating the side effects.

[0040] In a third aspect, the present application provides use of the traditional Chinese medicine composition of the first aspect in the preparation of a medicament for treating a skin disease.

[0041] Further, the skin disease includes atopic dermatitis, eczema, dermatitis, allergic dermatitis and psoriasis.

[0042] Preferably, the skin disease is atopic dermatitis.

[0043] More preferably, the skin disease is atopic dermatitis with heat accumulation in the heart and spleen.

[0044] The medicinal properties and effects of each traditional Chinese medicine in the present application are as follows:

[0045] Radix Rehmanniae: sweet in taste and cold in nature, and it is attributed to the heart, liver and kidney channels. It has the effects of clearing heat and cooling blood, nourishing yin and generating fluid. It is used for heat entering the blood, warm toxin causing rashes, hemoptysis and hematochezia, heat damaging yin, dry tongue, thirst, constipation, yin deficiency causing fever, bone and heat, and internal heat causing polydipsia.

[0046] Gardenia: Bitter in taste and cold in nature. It enters the heart, lung, and triple burner meridians. It has the effects of purging fire and relieving irritability, clearing heat and promoting diuresis, cooling blood and detoxifying; externally, it reduces swelling and relieves pain. It is used for feverish irritability, damp-heat jaundice, painful urination, hematemesis and epistaxis due to blood heat, red and swollen eyes, and carbuncles caused by fire toxins; externally, it is used to treat sprains and contusions.

[0047] Hawthorn: Sour and sweet in taste, slightly warm in nature. It enters the spleen, stomach, and liver meridians. It has the effects of promoting digestion and strengthening the stomach, regulating qi and dispersing blood stasis, and resolving turbidity and lowering lipids. It is used for food stagnation due to excessive meat consumption, abdominal distension, diarrhea and abdominal pain, amenorrhea due to blood stasis, postpartum blood stasis, stabbing pain in the heart and abdomen, chest pain, hernia pain, and hyperlipidemia.

[0048] Shenqu (Medicated Leaven): Sweet and pungent in taste, warm in nature. It enters the spleen and stomach meridians. It has the effects of strengthening the spleen and stomach, promoting digestion and regulating the middle jiao (digestive system). It treats food stagnation, chest tightness and abdominal distension, vomiting and diarrhea, postpartum abdominal pain due to blood stasis, and abdominal distension and hard masses in children.

[0049] Scutellaria baicalensis: Bitter in taste and cold in nature. It enters the lung, gallbladder, spleen, large intestine, and small intestine meridians. It has the effects of clearing heat and drying dampness, purging fire and detoxifying, stopping bleeding, and calming the fetus. It is used for damp-heat syndrome, summer-heat syndrome, chest tightness and nausea, damp-heat fullness, diarrhea, jaundice, lung-heat cough, high fever and thirst, hematemesis and epistaxis due to blood heat, carbuncles and boils, and threatened abortion.

[0050] Lophatherum gracile: Sweet and bland in taste, cold in nature. It enters the heart, stomach, and small intestine meridians. It has the effects of clearing heat and purging fire, relieving irritability and quenching thirst, and promoting urination. It is used for feverish thirst, scanty and painful urination, and sores in the mouth and tongue.

[0051] Fructus Aurantii Immaturus: Bitter, pungent, and sour in taste, and slightly cold in nature. It enters the spleen and stomach meridians. It has the effects of regulating qi and relieving chest tightness, promoting circulation and relieving bloating. It is used for qi stagnation in the chest and hypochondrium, abdominal distension and pain, indigestion, phlegm retention, and organ prolapse.

[0052] Uncaria rhynchophylla: Sweet in taste and cool in nature. It enters the liver and pericardium meridians. It has the effects of calming wind and relieving convulsions, clearing heat and soothing the liver. It is used for internal wind in the liver, epilepsy and convulsions, high fever convulsions, colds with convulsions, infantile convulsions, eclampsia in pregnancy, headache and dizziness.

[0053] Purslane: Sour in taste and cold in nature. It enters the liver and large intestine meridians. It has the effects of clearing heat and detoxifying, cooling blood and stopping bleeding, and stopping dysentery. It is used for dysentery caused by heat toxins, carbuncles and boils, eczema, erysipelas, snake and insect bites, hematochezia, hemorrhoidal bleeding, and metrorrhagia.

[0054] Honeysuckle: Sweet in taste and cold in nature. It enters the lung, heart, and stomach meridians. It has the effects of clearing heat and detoxifying, and dispersing wind-heat. It is used for carbuncles, boils, sore throat, erysipelas, dysentery due to heat toxin, wind-heat cold, and febrile diseases.

[0055] Dictamnus dasycarpus root bark: Bitter in taste and cold in nature. It enters the spleen, stomach, and bladder meridians. It has the effects of clearing heat and drying dampness, dispelling wind and detoxifying. It is used for damp-heat sores, weeping eczema, urticaria, scabies, rheumatic arthralgia, jaundice, and dark urine.

[0056] Largeleaf privet leaf: bitter, cold. Heart, stomach. Clearing heat and detoxifying, cooling blood and removing macula. For high fever, coma, macula, mumps, laryngalgia, erysipelas, abscess.

[0057] Atractylodes: bitter, warm. Spleen, stomach, liver. Dry wet spleen, dispel wind and cold, eyesight. For wetness in the middle, abdominal distension, diarrhea, edema, beriberi, rheumatism, colds, night blindness, blurred eyes.

[0058] Raw oyster shell: salty, cold. Liver, gallbladder, kidney. Heavy, calm, hidden yang, yin, soft and hard. For palpitation, insomnia, dizziness, tinnitus, scrofula, phlegm, mass. Fried oyster shell astringent, astringent, analgesic. For night sweats, spermatorrhea, leukorrhagia, stomach pain, acid reflux.

[0059] Coptis: bitter, cold. Heart, spleen, stomach, liver, gallbladder, large intestine. Clearing heat and drying dampness, purging fire and detoxifying. For damp-heat distension, vomiting and acid reflux, diarrhea, jaundice, high fever, coma, heart fire, insomnia, palpitation, blood heat, epistaxis, red eyes, toothache, diabetes, abscess; external treatment of eczema, tinea, ear discharge. Wine Coptis is good at clearing upper jiao heat. For red eyes, mouth sores.

[0060] Peony: bitter, sour, slightly cold. Liver, spleen. It has the effects of calming the liver and cooling the blood, nourishing the blood and regulating the menstrual cycle, and astringing yin and stopping sweating. For blood deficiency, irregular menstruation, night sweats, sweating, hypochondriac pain, abdominal pain, limb spasm, headache and dizziness.

[0061] Radish seed: bitter, sweet, flat. Lungs, spleen, stomach. Digestion and elimination of flatulence, gas and phlegm. For food retention, abdominal pain, constipation, accumulation and diarrhea, phlegm accumulation, wheezing and cough.

[0062] Malt: sweet, flat. Spleen, stomach. Qi digestion, spleen and stomach, back milk and swelling. For food accumulation, abdominal pain, spleen deficiency, milk accumulation, breast pain, women stop lactation, liver and stomach pain. Spleen and stomach, liver and stomach. For spleen deficiency, milk accumulation. Digestion and elimination of food accumulation, women stop lactation. Digestion and elimination of food accumulation, abdominal pain.

[0063] Betel nut: bitter, pungent, warm. Stomach, large intestine. It has the effects of killing worms, eliminating accumulation, descending qi, and reducing water. For roundworm, ascarid, clonorchis sinensis disease, worm accumulation abdominal pain, accumulation and diarrhea, tenesmus, edema, beriberi, malaria.

[0064] The principle of the present application is:

[0065] Atopic dermatitis is identified as heart and spleen heat syndrome, heart fire and spleen deficiency syndrome, wind-damp heat accumulation syndrome, spleen deficiency and dampness accumulation syndrome, spleen deficiency and blood deficiency syndrome, and spleen-kidney yang deficiency syndrome. Traditional Chinese medicine believes that the pathogenesis of AD is mainly due to congenital predisposition and postnatal visceral imbalance, and "heart fire" and "spleen deficiency" run through the whole process of AD. It is said in Spleen and Stomach Theory that "when the spleen and stomach qi is weak, the heart fire is strong …… fire and original qi cannot coexist, one wins and one loses". It is explained that the pathological changes of heart and spleen play a key role in the evolution of AD. The relationship between heart and spleen is relatively close, and the spleen is the source of qi and blood, and the spleen is responsible for transformation, and the normal function of the spleen and stomach affects the absorption of nutrients. Heart is the mother of spleen, heart controls blood vessels, and the nourishment of heart blood is the key to the normal operation of the physiological function of the spleen. Weakness of the function of the spleen and stomach, disorder of transformation, and excessive heart fire lead to insufficient absorption and utilization of nutrients in the human body. The present application is further optimized on the basis of Zishuiqingxin Drink, and has the characteristics of good taste, fast effect, good curative effect and high safety

[0066] The traditional Chinese medicine composition in the application takes nourishing the kidney and clearing the heart, removing accumulation and promoting digestion as the basic treatment method, takes radix rehmanniae, gardenia and rhizoma coptidis as the monarch drug to nourish kidney water and clear heart fire, takes hawthorn and god's recipe as the ministerial drug to clear heat and purge fire, invigorate the spleen and stomach, and remove food retention, takes scutellaria baicalensis, lophatherum gracile, portulaca oleracea, isatis leaf, atractylodes, honeysuckle, malt, uncaria, peony, bai xian pi and raw oyster as the auxiliary drug to guide heart fire downward, clear heat and resolve toxicity, and relieve itching, and takes fructus aurantii and raphanus sativus as the ministerial drug to promote qi and remove stagnation. Beneficial effects

[0067] The traditional Chinese medicine composition in the application has the effects of quickly relieving skin lesions and relieving itching in the treatment of mild and moderate AD patients, has obvious advantages in controlling recurrence, and has good safety.

[0068] At present, there is a lack of oral drugs for treating atopic dermatitis or eczema in children or adolescents in the market, the traditional Chinese medicine composition in the application has obvious curative effect in the treatment of atopic dermatitis, the curative effect is better than that of Zishuiqingxin Drink in the treatment of mild and moderate AD patients, the taste is better, and the children are more likely to accept it, so the application has good application prospect in the market. BRIEF DESCRIPTION OF DRAWINGS

[0069] Fig. 1 is a typical case 1 initial diagnosis physical examination and tongue pulse result.

[0070] Fig. 2 is a typical case 1 second reexamination physical examination and tongue pulse result.

[0071] Fig. 3 is a typical case 2 initial diagnosis physical examination

[0072] Fig. 4 is a typical case 2 first reexamination physical examination

[0073] Fig. 5 is a typical case 2 second reexamination physical examination

[0074] Figure 6 is a typical case 3 initial physical examination

[0075] Figure 7 is a typical case 3 first follow-up physical examination

[0076] Figure 8 is a typical case 3 second follow-up physical examination

[0077] Figure 9 is a typical case 4 initial physical examination

[0078] Figure 10 is a typical case 4 second follow-up physical examination

[0079] Figure 11 is a typical case 5 initial physical examination

[0080] Figure 12 is a typical case 5 first follow-up physical examination

[0081] Figure 13 is a typical case 5 second follow-up physical examination

[0082] Figure 14 is a typical case 6 initial physical examination

[0083] Figure 15 is a typical case 6 initial physical examination

[0084] Figure 16 is a typical case 6 second follow-up physical examination

[0085] Figure 17 is a typical case 7 initial physical examination

[0086] Figure 18 is a typical case 7 first follow-up physical examination

[0087] Figure 19 is a typical case 7 second follow-up physical examination DETAILED DESCRIPTION

[0088] The specific embodiments of the present application will be further described with reference to the drawings. It is to be noted that the description of the embodiments is intended for the purpose of aiding in the understanding of the present application, and is in no way intended to limit the present application. Furthermore, the technical features involved in the embodiments described below can be combined with each other as long as there is no conflict.

[0089] The experimental methods in the following examples are all routine methods unless specifically stated otherwise. The experimental materials used in the following examples are all commercially available unless specifically stated otherwise.

[0090] Terminology

[0091] The "Zi Shui Qing Xin Yin" of this invention is a traditional Chinese medicine composition as described in Chinese Patent CN 115054662 B, which is made from the following traditional Chinese medicines in parts by weight: The principal ingredient consists of the following: 10-30 parts of Rehmannia glutinosa and 5-25 parts of Gardenia jasminoides; the assistant ingredient consists of the following ingredients A or B: where A is: 5-20 parts of Scrophularia ningpoensis and 5-15 parts of Lophatherum gracile; where B is: 5-20 parts of Scrophularia ningpoensis and 5-15 parts of Lophatherum gracile, and one or two selected from 5-15 parts of chicken gizzard lining and 5-10 parts of Areca catechu; the adjuvant ingredient consists of the following ingredients C or D: C consists of: 5-20 parts of Uncaria rhynchophylla, 10-30 parts of Imperata cylindrica, and 5-15 parts of Crataegus pinnatifida; D consists of: 5-20 parts of Uncaria rhynchophylla, 10-30 parts of Imperata cylindrica, 5-15 parts of Crataegus pinnatifida, and one or more of the following: 5-15 parts of Lonicera japonica, 5-15 parts of Hordeum vulgare, 5-15 parts of Lycium chinense root bark, 1-5 parts of Juncus effusus, 5-30 parts of Portulaca oleracea, 5-15 parts of Forsythia suspensa, 5-30 parts of Ostrea gigas, 5-15 parts of Citrus reticulata peel, or 5-15 parts of Poria cocos.

[0092] Example 1: Traditional Chinese Medicine Composition

[0093] Chinese herbal composition 1: 20g Rehmannia glutinosa, 10g Gardenia jasminoides, 15g Crataegus pinnatifida, 15g Massa fermentata, 6g Scutellaria baicalensis, 6g Lophatherum gracile, 6g Citrus aurantium, 15g Uncaria rhynchophylla, 30g Portulaca oleracea, and 10g Lonicera japonica.

[0094] Chinese herbal composition 2: 15g Rehmannia glutinosa, 10g Gardenia jasminoides, 10g Crataegus pinnatifida, 10g Massa fermentata, 5g Scutellaria baicalensis, 5g Lophatherum gracile, 5g Citrus aurantium, 10g Uncaria rhynchophylla, 30g Portulaca oleracea, 15g Lonicera japonica, 15g Dictamnus dasycarpus, and 6g Areca catechu.

[0095] Traditional Chinese Medicine Composition 3: 30g Rehmannia glutinosa, 10g Gardenia jasminoides, 15g Crataegus pinnatifida, 15g Massa fermentata, 6g Scutellaria baicalensis, 6g Isatis indigotica, 30g Hordeum vulgare, 20g Raphanus sativus, and 15g Dictamnus dasycarpus.

[0096] Chinese herbal composition 4: 30g Rehmannia glutinosa, 10g Gardenia jasminoides, 15g Crataegus pinnatifida, 15g Massa fermentata, 10g Scutellaria baicalensis, 15g Lophatherum gracile, 10g Citrus aurantium, 15g Uncaria rhynchophylla, and 60g Portulaca oleracea.

[0097] Chinese herbal composition 5 consists of 30g Rehmannia glutinosa, 15g Gardenia jasminoides, 15g Crataegus pinnatifida, 15g Massa fermentata, 10g Scutellaria baicalensis, 10g Isatis indigotica, 30g Hordeum vulgare, 20g Raphanus sativus, 10g Paeonia lactiflora, and 15g Dictamnus dasycarpus.

[0098] Chinese herbal composition 6 consists of 30g Rehmannia glutinosa, 15g Gardenia jasminoides, 10g Crataegus pinnatifida, 10g Massa fermentata, 5g Scutellaria baicalensis, 10g Isatis indigotica, 30g Hordeum vulgare, 20g Raphanus sativus, 30g Ostrea gigas, and 20g Uncaria rhynchophylla.

[0099] Chinese herbal composition 7 consists of 30g Rehmannia glutinosa, 6g Coptis chinensis, 30g Crataegus pinnatifida, 20g Massa fermentata, 30g Atractylodes lancea, 5g Isatis indigotica, 20g Raphanus sativus, 10g Dictamnus dasycarpus, and 30g Lonicera japonica.

[0100] Chinese herbal composition 8 consists of 30g Rehmannia glutinosa, 5g Coptis chinensis, 20g Crataegus pinnatifida, 20g Massa fermentata, 20g Atractylodes lancea, 5g Isatis indigotica, 15g Raphanus sativus, 10g Dictamnus dasycarpus, and 30g raw oyster shell.

[0101] Preparation method

[0102] Weigh the required Chinese medicinal materials according to the proportions, put them into a decoction pot, add 8 times the amount of water and soak for 30 minutes, decoct for 25 minutes the first time, add 6 times the amount of water and decoct for 25 minutes the second time, combine the decoctions, concentrate and filter to 400mL (for children, it can be concentrated to 150-200mL).

[0103] Example 2 Clinical Study 1

[0104] 1. Method

[0105] This study employs a prospective, randomized, single-blind, controlled design to conduct a standardized clinical trial to verify the efficacy of an optimized TCM treatment regimen for atopic dermatitis (Siwanfeng) with heart and spleen heat accumulation syndrome.

[0106] 2. Research Subjects

[0107] This study selected patients with atopic dermatitis (Siwanfeng) and heart and spleen heat accumulation syndrome from the outpatient departments of the Department of Dermatology at Huairou District Traditional Chinese Medicine Hospital and Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University as research subjects.

[0108] 3. Diagnostic criteria

[0109] 3.1 Western Medicine Diagnostic Criteria

[0110] Refer to the clinical diagnostic criteria for mild to moderate atopic dermatitis in the "Chinese Guidelines for the Diagnosis and Treatment of Atopic Dermatitis 2020 Edition" and "Chinese Clinical Dermatology".

[0111] The severity of atopic dermatitis was assessed using the SCORAD score: mild (SCORAD score 0-24), moderate (SCORAD score 25-50), and severe (SCORAD score >50).

[0112] 3.2 Traditional Chinese Medicine Diagnostic Criteria

[0113] This document is drafted with reference to the "Expert Consensus on Traditional Chinese Medicine Diagnosis and Treatment of Atopic Dermatitis" (Chinese Journal of Integrated Traditional and Western Medicine Dermatology and Venereology, 2013) and the "Standards for Diagnosis and Efficacy of Diseases in Traditional Chinese Medicine" (National Standard of Traditional Chinese Medicine).

[0114] Heart and spleen heat accumulation syndrome:

[0115] Recurrent erythema, edema, papules, vesicles, or nodules on the face, neck, elbows, popliteal fossa, and trunk, sometimes accompanied by erosion and exudation, and intense itching. Other symptoms include irritability, dry mouth, restless sleep, constipation or bowel movements every few days, a red tongue or a red tongue tip with prickles, a thick or greasy tongue coating, and a slippery pulse.

[0116] 4. Discharge Standards

[0117] 4.1 Inclusion criteria

[0118] ① Meets the above-mentioned clinical diagnostic criteria for moderate atopic dermatitis in Western medicine (25 < SCORAD score ≤ 50);

[0119] ② It meets the diagnostic criteria for the syndrome of heat accumulation in the heart and spleen;

[0120] ③ Age 2-18 years old, gender not limited;

[0121] ④ Good compliance; able to cooperate with the collection of clinical data;

[0122] ⑤ No systemic use of glucocorticoids, immunosuppressants, biologics, or ultraviolet light was observed within the four weeks prior to the study;

[0123] ⑥ No oral antihistamines were taken within one week prior to the study;

[0124] ⑦ No glucocorticoids, calcineurin inhibitors, or phosphodiesterase 4 were used within one week prior to the study;

[0125] ⑧ The individual or their guardian must sign an informed consent form (signed by the guardian on their behalf), voluntarily participate in the trial, and the informed consent process must comply with GCP regulations.

[0126] Those who meet all of the above conditions are eligible for inclusion and will be included in this study.

[0127] 4.2 Exclusion Criteria

[0128] ① Patients with any other skin diseases that may interfere with the evaluation of test results;

[0129] ② Individuals with serious primary diseases of the cardiovascular, cerebrovascular, liver, kidney, and hematopoietic systems, as well as autoimmune diseases, skin tumors, or mental illness;

[0130] ③ Patients with concurrent severe skin or systemic infections;

[0131] ④ Patients with a history of allergy to any component of the research drug;

[0132] ⑤ Patients who cannot receive traditional Chinese medicine decoction treatment;

[0133] ⑥ Patients who are participating in other drug clinical trials.

[0134] If any of the above criteria are met, the patient will be excluded and not included in this study.

[0135] 4.3 Rejection Criteria

[0136] ① Those who were mistakenly included but did not meet the inclusion criteria;

[0137] ②Those who use other drugs or treatment plans during the treatment process, affecting the assessment of efficacy.

[0138] 4.4 Shedding Criteria

[0139] ①Those who entered the trial treatment but ultimately did not complete the clinical observation;

[0140] ② Those who did not have regular follow-up visits during treatment and were lost to follow-up for various reasons during the follow-up period;

[0141] ③ Those who are unwilling to continue clinical trials during the treatment process.

[0142] 4.5 Standard for Complete Suspension

[0143] ① Those who experience serious adverse reactions or allergic reactions during clinical trials;

[0144] ② If, during the research process, it is found that the medication used not only fails to improve symptoms but also further aggravates the condition; or if there are significant errors in the experimental design; or if there are large deviations during the implementation process that make it impossible to evaluate the efficacy of the medication;

[0145] ③ Researchers consider the necessity of terminating the trial from a medical perspective.

[0146] 5. Grouping and Treatment

[0147] 5.1 Grouping

[0148] The subjects were divided into a treatment group and a control group.

[0149] 5.2 Randomization Scheme

[0150] A computer randomly generates random numbers, and researchers collect medications according to the order in which participants are enrolled. After verifying and registering the prescription, the dispensing staff distributes the medication, emphasizes precautions, and the participants sign to receive their medication.

[0151] 5.3 Sampling Method

[0152] The enrolled cases were randomly assigned to the experimental group and the control group in a 1:1 ratio.

[0153] 5.4 Sample Size

[0154] This study was an exploratory study. Based on clinical experience and considering a clinical dropout rate of 20%, the total number of cases in the trial was 66 (33 in the treatment group and 33 in the control group).

[0155] 5.5 Treatment Methods

[0156] Experimental group: Oral administration of Chinese herbal combinations 1 and 2. The combined decoction was concentrated and filtered to 400 mL (150-200 mL for children), and divided into two oral doses, taken half an hour after meals, once in the morning and once in the evening.

[0157] Control group: Administered Eloson cream (Bayer Pharmaceuticals (Shanghai) Co., Ltd., National Drug Approval Number H19991418) topically, applying a thin, even layer to the affected skin. For the first two weeks, Eloson cream was applied once daily; after two weeks, the frequency and amount of application were gradually reduced based on the condition of the skin lesions. Avoid applying the medication to the face and body folds.

[0158] Treatment duration: 4 weeks. Patients will return for follow-up visits every week to record the degree of improvement. Health education will be provided to both groups of children and their families, advising them to avoid spicy, irritating, and cold foods, avoid washing the affected area with hot water, and routinely apply topical moisturizers.

[0159] 5.6 Blinding

[0160] Medication collection: Patients' family members collect their medications at the clinical trial drug window according to their random number. The medications are distributed and registered by designated personnel.

[0161] 6. Evaluation of therapeutic effect

[0162] 6.1 Primary efficacy endpoint – SCORAD score

[0163] The SCORAD score, proposed by the European Atopic Dermatitis Study Group, is currently the most widely used disease severity scale in clinical research and practice. It mainly includes the extent of skin lesions (A), the severity of skin lesions (B), and the patient's subjective symptoms (C). Details are as follows (see Table 1):

[0164] A. Calculation of the extent of skin lesions: Front of the body: head 4.5%, trunk 18%, upper limb (unilateral) 4.5%, lower limb (unilateral) 9%; the calculation method for the back of the body is the same as that for the front; in addition, the vulva is 1%, for a total score of 100 points.

[0165] B. Severity of skin lesions: The severity of skin lesions is divided into four levels: none, mild, moderate, and severe, using a score of 0-3 for estimation. This is mainly assessed by evaluating erythema, papules / edema, crusting, lichenification / thickening, epidermal peeling at the lesion site, and dryness of the skin in non-lesion areas.

[0166] C. Subjective Symptoms (Degree of Itching and Sleep Impact): The average level of itching over the past 3 days and the average degree of sleep impact over the past 3 nights were assessed based on the patient's actual condition, using a visual analog scale (see Appendix 1) for scoring. The specific scoring criteria are as follows: 0 points: no obvious itching; <3 points: itching sensation, but tolerable and does not affect sleep; 4-6 points: moderate itching sensation, still tolerable, but affects sleep; 7-10 points: severe itching sensation, unbearable for the patient, making it difficult to fall asleep.

[0167] The formula for calculating the SCORAD score is: A / 5 + 7B / 2 + C.

[0168] Table 1 SCORAD Rating Scale

[0169] 6.2 Research Evaluation Indicators

[0170] Combined medication: If other medications are used in combination, they must be recorded in a timely manner. If they affect the trial, they should be excluded.

[0171] Adherence: During clinical trials, the facility maintains a system for counting remaining prescription drugs. After the trial, the investigator is responsible for counting the number of remaining prescription drugs for the subjects under their supervision to monitor the subjects' medication adherence.

[0172] 6.3 Efficacy Evaluation Criteria

[0173] This was drafted in accordance with the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs" (China Medical Science and Technology Press, 2002, 5).

[0174] The calculation formula (nimodipine method) is: Efficacy index = [(pre-treatment SCORAD total score - post-treatment SCORAD total score) / pre-treatment SCORAD total score] × 100%.

[0175] Therapeutic effect evaluation:

[0176] Clinical cure: the rash has basically subsided, the symptoms have disappeared, and the efficacy rate is ≥90%;

[0177] Significant effect: Most of the rash subsided, and symptoms were significantly improved; efficacy rate ≤ 60% < 90%;

[0178] Effective: The rash partially subsided, and the symptoms improved; the efficacy rate was 20% ≤ efficacy rate < 60%.

[0179] Ineffective: The rash does not subside significantly, the symptoms do not improve or even worsen, and the efficacy rate is <20%;

[0180] Overall effective rate = [(number of cured cases + number of cases with significant improvement + number of cases with improvement) / total number of cases] × 100%.

[0181] 7. Research Summary

[0182] All cases that met the trial protocol, had good adherence, did not take prohibited medications during the trial, completed the required information in the CRF, or took 80% to 120% of the amount of investigational drug, underwent statistical analysis of the efficacy data based on the protocol compliance dataset.

[0183] 8. Statistical Analysis and Content

[0184] Statistical analysis will be performed using SPSS 22.0 statistical analysis software. All statistical tests will be two-tailed, and a p-value less than or equal to 0.05 will be considered statistically significant. Chi-square tests will be used for count data, and continuous data will be expressed as mean ± standard deviation (x ± s). Paired-samples t-tests will be used for within-group comparisons, and independent-samples t-tests will be used for between-group comparisons. The rank-sum test will be used for comparing ordinal data. Pearson's correlation test will be used for correlation analysis.

[0185] 9. Research Results

[0186] 9.1 Case Data

[0187] Cases were collected from patients visiting the Dermatology Outpatient Department of Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, between May 2023 and April 2024. After the Patient Case Report Form (CRF) was completed, two different data entry personnel entered and verified the data twice. A total of 66 patients were enrolled, with 5 dropping out due to personal reasons, resulting in 61 cases ultimately included in the statistical analysis. Of these, 31 were in the treatment group and 30 were in the control group.

[0188] 9.2 Baseline Data

[0189] Of the 61 patients, 33 were male and 28 were female, with a mean age of 7.93 ± 3.87 years and a mean disease duration of 4.22 ± 3.65 years. Before treatment, the sex of the treatment group and the control group was determined by a chi-square test. The patients' age and disease duration in both groups followed a normal distribution with homogeneous variances. An independent samples t-test indicated no significant difference between the two groups.

[0190] 9.3 Evaluation of therapeutic effect

[0191] (a) SCORAD score

[0192] The results are shown in Table 2. Comparing the total SCORAD scores before and after treatment, the paired t-test showed that the total SCORAD scores of both the treatment group and the control group decreased before and after treatment, and the difference was statistically significant (P < 0.05). The decrease in the total SCORAD score of the treatment group was more significant. The difference in SCORAD scores between the treatment group and the control group was statistically significant (P < 0.05), suggesting that the patients in the treatment group experienced more significant relief after 4 weeks.

[0193] Table 2. Comparison of SCORAD scores before and after treatment Note: After treatment, the treatment group was significantly different from the control group (P < 0.05).

[0194] (II) Overall efficacy evaluation

[0195] The results are shown in Table 3. The SCORAD index of the two treatment groups was divided into four levels: cured, significantly effective, effective, and ineffective. The chi-square test was used for analysis. The total number of effective cases in the experimental group was 27, with a total effective rate of 87.1%. The total number of effective cases in the control group was 22, with a total effective rate of 63.33%. The difference between the two groups was statistically significant (P < 0.05).

[0196] Table 3. Comparison of SCORAD scores before and after treatment

[0197] 9.4 Adverse Reactions

[0198] No adverse reactions were observed in either the treatment group or the control group.

[0199] 10. Conclusion

[0200] This clinical study demonstrates that the herbal composition of this invention can rapidly reduce skin lesions and relieve itching in the treatment of mild to moderate atopic dermatitis (AD) patients, and shows significant advantages in controlling recurrence. Furthermore, the herbal composition of this invention exhibits good safety. Currently, there is a lack of oral medications for treating atopic dermatitis or eczema in children or adolescents. This research confirms the significant efficacy of the herbal composition of this invention in treating atopic dermatitis. In mild to moderate AD patients, its efficacy is superior to Zishui Qingxin Yin (a traditional Chinese medicine), and it has a better taste, making it more easily accepted by children, thus showing promising application prospects in the market.

[0201] Example 3 Clinical Study 2

[0202] 1. Method

[0203] This study employs a prospective, randomized, single-blind, controlled design to conduct a standardized clinical trial to verify the efficacy of an optimized TCM treatment regimen for atopic dermatitis (Siwanfeng) with heart and spleen heat accumulation syndrome.

[0204] 2. Research Subjects

[0205] This study selected patients with atopic dermatitis (Siwanfeng) and heart and spleen heat accumulation syndrome from the dermatology outpatient clinic of Beijing Hospital of Traditional Chinese Medicine, affiliated with Capital Medical University, as the research subjects.

[0206] 3. Diagnostic criteria

[0207] 3.1 Western Medicine Diagnostic Criteria

[0208] Refer to the clinical diagnostic criteria for mild to moderate atopic dermatitis in the "Chinese Guidelines for the Diagnosis and Treatment of Atopic Dermatitis 2020 Edition" and "Chinese Clinical Dermatology".

[0209] The severity of eczema was assessed using the Eczema Area and Severity Index (EASI): Mild: EASI score ≤ 7; Moderate: 7 < EASI score ≤ 21; Severe: EASI score > 21.

[0210] 3.2 Traditional Chinese Medicine Diagnostic Criteria

[0211] This document is drafted with reference to the "Expert Consensus on Traditional Chinese Medicine Diagnosis and Treatment of Atopic Dermatitis" (Chinese Journal of Integrated Traditional and Western Medicine Dermatology and Venereology, 2013) and the "Standards for Diagnosis and Efficacy of Diseases in Traditional Chinese Medicine" (National Standard of Traditional Chinese Medicine).

[0212] Heart and Spleen Heat Accumulation Syndrome: Recurrent erythema, edema, papules, vesicles, or nodules on the face, neck, elbows, popliteal fossa, trunk, etc., which may be accompanied by erosion and exudation, and significant and severe itching. Symptoms include irritability, dry mouth, restless sleep, dry stools or bowel movements every few days, red tongue or red tongue tip or with prickles, thick or greasy tongue coating, and slippery pulse.

[0213] 4. Discharge Standards

[0214] 4.1 Inclusion criteria

[0215] ① Meets the diagnostic criteria of both Western and Traditional Chinese Medicine;

[0216] ② Age between 2 and 18 years old, gender not limited;

[0217] ③ No systemic use of hormones, immunosuppressants, or ultraviolet radiation therapy within the past 4 weeks;

[0218] ④ No systematic use of biological agents or targeted drugs within the past 3 months;

[0219] ⑤ No systemic use of antihistamines within the past two weeks;

[0220] ⑥ Obtain permission from the guardian, sign an informed consent form, and voluntarily participate in the trial.

[0221] 4.2 Exclusion Criteria

[0222] ① Patients with any other skin diseases that may interfere with the evaluation of test results;

[0223] ② Individuals with serious primary diseases of the cardiovascular, cerebrovascular, liver, kidney, and hematopoietic systems, as well as autoimmune diseases, skin tumors, or mental illness;

[0224] ③ Patients with concurrent severe skin or systemic infections;

[0225] ④ Patients with a history of allergy to any component of the research drug;

[0226] ⑤ Patients who cannot receive treatment with traditional Chinese medicine compound preparations;

[0227] ⑥ Patients who are participating in other drug clinical trials.

[0228] 4.3 Rejection Criteria

[0229] ① Those who were mistakenly included but did not meet the inclusion criteria;

[0230] ②Those who use other drugs or treatment plans during the treatment process, affecting the assessment of efficacy.

[0231] 4.4 Shedding Criteria

[0232] ①Those who entered the trial treatment but ultimately did not complete the clinical observation;

[0233] ② Those who did not have regular follow-up visits during treatment and were lost to follow-up for various reasons during the follow-up period;

[0234] ③ Those who are unwilling to continue clinical trials during the treatment process.

[0235] 4.5 Standard for Complete Suspension

[0236] ① Those who experience serious adverse reactions or allergic reactions during clinical trials;

[0237] ② If, during the research process, it is found that the medication used not only fails to improve symptoms but also further aggravates the condition; or if there are significant errors in the experimental design; or if there are large deviations during the implementation process that make it impossible to evaluate the efficacy of the medication;

[0238] ③ Researchers consider the necessity of terminating the trial from a medical perspective.

[0239] 5. Grouping and Treatment

[0240] 5.1 Grouping

[0241] The subjects were divided into an experimental group and a control group.

[0242] 5.2 Randomization Scheme

[0243] A computer randomly generates random numbers, and researchers collect medications according to the order in which participants are enrolled. After verifying and registering the prescription, the dispensing staff distributes the medication, emphasizes precautions, and the participants sign to receive their medication.

[0244] 5.3 Sampling Method

[0245] The enrolled cases were randomly assigned to the experimental group and the control group in a 2:1 ratio.

[0246] 5.4 Sample Size

[0247] The PASS11 software was used to calculate the sample size using the superiority clinical trial sample formula. Based on previous trials and literature review, the EASI75 efficacy rate was 32% in the control group and 65% in the experimental group, with α = 0.05 and 1-β = 0.80. The sample size was calculated as follows: 48 cases in the control group and 96 cases in the experimental group. Based on clinical experience and considering a 20% dropout rate, the total number of cases was 162, with 108 cases in the experimental group and 54 cases in the control group.

[0248] 5.5 Treatment Methods

[0249] Experimental group 1: The patient was given oral administration of the traditional Chinese medicine composition 3, plus topical application of 0.1% mometasone furoate cream.

[0250] Experimental group 2: Administered oral Chinese medicine composition 4, plus topical application of 0.1% mometasone furoate cream.

[0251] Experimental group 3: The patient was given oral administration of the traditional Chinese medicine composition 5, plus topical application of 0.1% mometasone furoate cream.

[0252] Experimental group 4: The patient was given a traditional Chinese medicine composition 6 orally, plus 0.1% mometasone furoate cream applied topically.

[0253] Experimental group 5: The patient was given oral administration of the traditional Chinese medicine composition 7, plus topical application of 0.1% mometasone furoate cream.

[0254] Experimental group 6: The patient was given oral administration of the traditional Chinese medicine composition 8, plus topical application of 0.1% mometasone furoate cream.

[0255] The traditional Chinese medicine compound prescription adopts an age-stratified dosing method, dividing the patients into three age groups: 2-6 years old, 7-12 years old, and 13-18 years old. The medicine is administered orally according to the age group, and the medicine is composed of ingredients in a 2:3:4 ratio. Each dose is decocted into 100ml and taken orally twice a day, once in the morning and once in the evening.

[0256] Control group: Administered Eloson cream (Bayer Pharmaceuticals (Shanghai) Co., Ltd., National Drug Approval Number H19991418) topically, applying a thin, even layer to the affected skin. For the first two weeks, Eloson cream was applied once daily; after two weeks, the frequency and amount of application were gradually reduced based on the condition of the skin lesions. Avoid applying the medication to the face and body folds.

[0257] Treatment duration: 4 weeks. Patients will return for follow-up visits every week to record the degree of improvement. Health education will be provided to both groups of children and their families, advising them to avoid spicy, irritating, and cold foods, avoid washing the affected area with hot water, and routinely apply topical moisturizers.

[0258] The prepared herbal pieces were provided by Beijing Hospital of Traditional Chinese Medicine, affiliated with Capital Medical University.

[0259] 5.6 Blinding

[0260] Medication collection: Patients' family members collect their medications at the clinical trial drug window according to their random number. The medications are distributed and registered by designated personnel.

[0261] 6. Evaluation of therapeutic effect

[0262] 6.1 Key efficacy endpoint – Eczema Area and Severity Index (EASI)

[0263] 6.2 Research Evaluation Indicators

[0264] Combined medication: If other medications are used in combination, they must be recorded in a timely manner. If they affect the trial, they should be excluded.

[0265] Adherence: During clinical trials, the facility maintains a system for counting remaining prescription drugs. After the trial, the investigator is responsible for counting the number of remaining prescription drugs for the subjects under their supervision to monitor the subjects' medication adherence.

[0266] 6.3 Efficacy Evaluation Criteria

[0267] Using the EASI75 achievement rate, the eczema area and severity index decreased by ≥75% from baseline.

[0268] 7. Research Summary

[0269] All cases that met the trial protocol, had good adherence, did not take prohibited medications during the trial, completed the required information in the CRF, or took 80% to 120% of the amount of investigational drug, underwent statistical analysis of the efficacy data based on the protocol compliance dataset.

[0270] 8. Statistical Analysis and Content

[0271] Statistical analysis was performed using SPSS Statistics 25.0 software. For continuous data that conform to a normal distribution, [the following method was used]. The independent samples t-test was used for comparisons between the two groups. If the data did not conform to a normal distribution, M(P25, P75) was used for description, and nonparametric tests were used for comparisons between the two groups. Count data were described using percentages (%), and the chi-square test or Fisher's exact test was used. Nonparametric tests were used for comparisons between the two groups of ordinal data. A p-value < 0.05 was considered statistically significant.

[0272] 9. Research Results

[0273] 9.1 Case Data

[0274] From September 2023 to September 2025, 162 children with atopic dermatitis exhibiting the syndrome of "heart and spleen heat accumulation" who visited Beijing Hospital of Traditional Chinese Medicine, affiliated with Capital Medical University, were randomly assigned to a control group and an experimental group using a random number table. The control group consisted of 54 patients, and the experimental group consisted of 108 patients. In the control group, 54 patients were enrolled, with 3 excluded due to poor compliance, resulting in 51 cases. In experimental group 1, 58 patients were enrolled, with 2 excluded due to poor compliance, resulting in 56 cases. Experimental groups 2, 3, 4, 5, and 6 each enrolled 10 patients, all of whom completed the study. In the control group, there were 28 males and 23 females; the mean age was (7.20±3.15) years; and the mean disease duration was (4.08±2.85) years. In experimental group 1, there were 50 males and 56 females; the mean age was (8.25±3.43) years; and the mean disease duration was (4.85±3.57) years. There were no statistically significant differences in general characteristics between the groups (P > 0.05). There were also no statistically significant differences between the groups (P > 0.05). This study was approved by the Clinical Research Ethics Committee of Beijing Hospital of Traditional Chinese Medicine, Capital Medical University (Approval No. BJZYYB-2023-72).

[0275] 9.2 Evaluation of therapeutic effect

[0276] Table 4 shows a comparison of EASI scores before and after treatment in patients:

[0277] Table 4 Comparison of EASI scores before and after treatment

[0278] Table 5 shows the comparison of EASI75 levels before and after treatment in patients:

[0279] Table 5 Comparison of EASI75 before and after treatment.

[0280] The experimental results are shown in Table 4. After treatment, the EASI scores of all groups decreased significantly, and the overall effect of the experimental group was better than that of the control group. After 4 weeks of treatment, there was a statistically significant difference in the EASI 75 target achievement rate between the experimental group and the control group (P < 0.05), with the experimental group significantly better than the control group. As shown in Table 5, after treatment, there was no statistically significant difference between the experimental groups (P > 0.05), but the target achievement rate of the experimental group was better than that of the control group.

[0281] 9.3 Adverse Reactions

[0282] No adverse reactions were observed in either the treatment group or the control group.

[0283] 10 Conclusions

[0284] This clinical study demonstrates that the herbal composition of this invention can rapidly reduce skin lesions and relieve itching in the treatment of mild to moderate atopic dermatitis (AD) patients, and shows significant advantages in controlling recurrence. Furthermore, the herbal composition of this invention exhibits good safety. Currently, there is a lack of oral medications for treating atopic dermatitis or eczema in children or adolescents. This research confirms the significant efficacy of the herbal composition of this invention in treating atopic dermatitis. In mild to moderate AD patients, its efficacy is superior to Zishui Qingxin Yin (a traditional Chinese medicine), and it has a better taste, making it more easily accepted by children, thus showing promising application prospects in the market.

[0285] Example 4 Typical Case

[0286] Case 1

[0287] Patient: Male, 7 years old; Date of visit: December 17, 2024 (Figure 1)

[0288] Chief complaint: Rash all over the body accompanied by itching for 2 years

[0289] Present illness: Two years ago, the patient developed a skin rash without any obvious cause. Topical application of Elosone was ineffective. Current SCORAD score: 47.6. The patient is nauseous, enjoys eating meat, has a cough with yellow phlegm and yellow nasal discharge, and has bowel movements every 2-3 days. The tongue is red with a thick, greasy white coating, and the pulse is slippery.

[0290] Past medical history: Healthy; Allergy history: Allergic to eggs, milk, and kidney beans.

[0291] Physical examination: Rough and dry skin, numerous red papules on the body, accompanied by epidermal erosion, erosion and exudation, blood crusts, and scratch marks. Dark red tongue with a white and greasy coating, and slippery pulse.

[0292] Diagnosis: Traditional Chinese Medicine diagnosis: Four-bend wind—Heart and spleen heat accumulation syndrome; Western medicine diagnosis: Atopic dermatitis

[0293] Prescription and treatment: 20g Rehmannia glutinosa, 10g Gardenia jasminoides, 6g Lophatherum gracile, 30g Portulaca oleracea, 15g Crataegus pinnatifida, 15g Massa fermentata, 6g Citrus aurantium, 6g Scutellaria baicalensis, 10g Lonicera japonica, 15g Uncaria rhynchophylla (added later). This formula nourishes yin, clears the heart, and promotes digestion.

[0294] Follow-up visit 1: December 31, 2023

[0295] After two weeks of treatment, the itching significantly decreased, and some skin lesions subsided, leaving pigmentation. Pale red patches remained on the neck with a few crusts. A few scattered red papules, scratch marks, and blood crusts were observed on the trunk and limbs. SCORAD score: 24.2. Appetite was good, and bowel movements occurred once daily. Tongue was red with a white coating, and pulse was slippery. Treatment and medication remained the same.

[0296] Second follow-up visit: January 7, 2024 (Figure 2)

[0297] After 4 weeks of treatment, mild itching persisted, and most skin lesions subsided. A very small number of red papules, a few scratch marks, and blood scabs remained scattered on the trunk and limbs. SCORAD score: 4.5. Appetite was good, and bowel movements occurred once daily. Tongue was red with a white coating, and pulse was slippery.

[0298] Case 2

[0299] Zhang XX, female, 2 years and 5 months old; date of initial consultation: November 12, 2024 (Figure 3).

[0300] Chief complaint: Generalized erythema and desquamation with itching for 2 years, with recurrence and worsening for 1 week.

[0301] Present Illness: Onset since childhood, with skin rashes and itching all over the body, gradually increasing in number. Consulted a local hospital, diagnosed with "eczema, atopic dermatitis," and prescribed oral loratadine syrup and traditional Chinese medicine, and topical application of acetaminophen and mupirocin ointment, but with poor results and recurring flare-ups. One week ago, the condition relapsed and worsened, with widespread red and light red patches on the head, neck, trunk, and limbs, along with scratch marks and scabs. Appetite is normal, bowel movements and urination are normal. Restlessness. EASI: 29.5. NRS score: pruritus 6, sleep VAS 8.

[0302] Past medical history: None. Family history: Mother has a history of allergic rhinitis, psoriasis, and urticaria. Allergy history: Milk.

[0303] Physical examination: Red and light red patches, scratches, and scabs were observed on the head, neck, trunk, and limbs. The tongue was red with a white coating. The pulse was slippery.

[0304] Diagnosis: Western medicine: Severe atopic dermatitis; Traditional Chinese medicine: Four-sided wind-heat syndrome of the heart and spleen.

[0305] Prescription and treatment: 15g Rehmannia glutinosa, 6g Gardenia jasminoides, 15g Crataegus pinnatifida, 15g Massa fermentata, 6g Scutellaria baicalensis, 8g Isatis indigotica, 15g Hordeum vulgare, 6g Raphanus sativus seed, 10g Dictamnus dasycarpus root bark. 14 doses in total. To nourish the kidneys, clear the heart, invigorate the spleen, and promote digestion.

[0306] Usage: One dose per day, decocted in water and taken warm; Dosage: 100mL, twice a day.

[0307] Follow-up appointment date: November 24, 2024 (Figure 4)

[0308] Present Illness: Follow-up visit for Alzheimer's disease (AD). Itching and sleep have significantly decreased; EASI: 15.4. VAS score: Itching 3 points, sleep 3 points. Much calmer at the time of presentation. A few pale red patches on the face, elbows, and popliteal fossa; generalized erythema, dry, with reduced desquamation, reduced scratch marks and scabs; slight epidermal erosion, no exudation. Appetite is good; bowel movements 2-3 times daily.

[0309] Physical examination: A few pale red patches on the face, elbows, and popliteal fossa; generalized erythema, dry, with reduced desquamation; scratch marks and scabs have lessened; minor epidermal erosion, no exudation. Pale red tongue with white coating. Slippery pulse.

[0310] Diagnosis: Western medicine: Atopic dermatitis (moderate); Traditional Chinese medicine: Four-sided wind-heat syndrome of the heart and spleen.

[0311] Prescription and treatment: 15g Rehmannia glutinosa, 6g Gardenia jasminoides, 15g Crataegus pinnatifida, 15g Massa fermentata, 6g Scutellaria baicalensis, 5g Isatis indigotica, 15g Hordeum vulgare, 6g Raphanus sativus seed, 6g Dictamnus dasycarpus root bark. 14 doses in total. To nourish the kidneys, clear the heart, invigorate the spleen, and promote digestion.

[0312] Usage: One dose per day, decocted in water and taken warm; Dosage: 100mL, twice a day.

[0313] Follow-up appointment date: December 7, 2024 (Figure 5)

[0314] Present Illness: Follow-up visit for Alzheimer's disease; itching relieved, rash partially subsided. EASI: 6.8. VAS score: itching 1 point, sleep 2 points. Currently, the patient has a light red rash all over the body, dry, with reduced scaling, less scratch marks and scabs, a small amount of epidermal erosion, and reduced ankle edema with no exudation. The patient is cheerful and smiling. Appetite is good, bowel movements are 2-3 times a day, occasionally loose.

[0315] Physical examination: A few pale red patches in the popliteal fossa. Red tongue with a thin white coating. Slippery pulse.

[0316] Diagnosis: Western medicine: Atopic dermatitis (mild); Traditional Chinese medicine: Four-bend wind-heart-fire-spleen accumulation syndrome

[0317] Prescription and treatment: Rehmannia glutinosa 10g, Gardenia jasminoides 3g, Crataegus pinnatifida 12g, Massa fermentata 12g, Scutellaria baicalensis 3g, Isatis indigotica 8g, Hordeum vulgare 10g, Raphanus sativus 6g, Dictamnus dasycarpus 5g. Continue maintenance treatment. A total of 14 doses. Tonifies the kidneys, clears the heart, invigorates the spleen, and promotes digestion.

[0318] Usage: One dose per day, decocted in water and taken warm; Dosage: 100mL, twice a day.

[0319] Case 3:

[0320] Patient: Wang X, male, 10 years old; Date of visit: December 17, 2024 (Figure 6)

[0321] Chief complaint: Rash all over the body accompanied by itching for 6 years, worsening in the last 4 weeks.

[0322] Present Illness: Six years ago, the patient developed a rash without any obvious cause. Topical application of Elosone provided temporary relief, but the rash recurred after discontinuation of the medication. Four weeks ago, the rash worsened after a cold. Currently, the rash is mainly scattered red and light red patches and papules on the extremities, accompanied by epidermal erosion and scratch marks. Some lesions are rough and thickened. Appetite is good, but stools are slightly dry. EASI score: 6.8. Pruritus NRS score: 6. Sleep VAS score: 4.

[0323] Past medical history: Allergic rhinitis; Family history: None; Allergy history: None.

[0324] Physical examination: The skin is rough and dry, with scattered red and light red patches and papules mainly on the extremities, accompanied by epidermal erosion and scratch marks. Some skin lesions are rough and thickened. The tongue is red with a thick white coating, and the pulse is slippery.

[0325] Diagnosis: Western medicine diagnosis: Atopic dermatitis (mild); Traditional Chinese medicine diagnosis: Four-sided wind-heat accumulation syndrome of the heart and spleen.

[0326] Prescription and treatment: Rehmannia glutinosa 15g, Gardenia jasminoides 10g, Crataegus pinnatifida 12g, Massa fermentata 12g, Scutellaria baicalensis 10g, Lophatherum gracile 10g, Citrus aurantium 10g, Uncaria rhynchophylla 15g, Portulaca oleracea 30g. 14 doses in total. Nourishes water, clears the heart, and promotes digestion.

[0327] Usage: One dose per day, decocted in water and taken warm; Dosage: 100mL, twice a day.

[0328] Follow-up visit 1: December 31, 2023 (Figure 7)

[0329] After two weeks of treatment, itching was significantly reduced, and some skin lesions had subsided, with only a few scratch marks remaining. A few scattered red papules, scratch marks, and scabs were observed on the limbs. EASI score: 3.2. Pruritus NRS score: 3. Sleep VAS score: 2.

[0330] Nake, one bowel movement per day. Red tongue, white coating, slippery pulse.

[0331] Diagnosis: Western medicine diagnosis: Atopic dermatitis (mild); Traditional Chinese medicine diagnosis: Four-sided wind-heat syndrome of the heart and spleen.

[0332] Prescription and treatment: Rehmannia glutinosa 15g, Gardenia jasminoides 10g, Crataegus pinnatifida 12g, Massa fermentata 12g, Scutellaria baicalensis 10g, Lophatherum gracile 10g, Citrus aurantium 10g, Uncaria rhynchophylla 15g, Portulaca oleracea 30g. 14 doses in total. Nourishes water, clears the heart, and promotes digestion.

[0333] Usage: One dose per day, decocted in water and taken warm; Dosage: 100mL, twice a day.

[0334] Second follow-up visit: January 7, 2024 (Figure 8)

[0335] After 4 weeks of treatment, mild itching and most skin lesions subsided. EASI score: 0.1. Pruritus NRS score: 1. Sleep VAS score: 0. Appetite: normal, bowel movements once a day. Tongue: red, coating: white, pulse: slippery.

[0336] Diagnosis: Western medicine diagnosis: Atopic dermatitis (mild); Traditional Chinese medicine diagnosis: Four-sided wind-heat accumulation syndrome of the heart and spleen.

[0337] Prescription and treatment: Rehmannia glutinosa 10g, Gardenia jasminoides 6g, Crataegus pinnatifida 10g, Massa fermentata 10g, Scutellaria baicalensis 5g, Lophatherum gracile 6g, Citrus aurantium 6g, Uncaria rhynchophylla 10g, Portulaca oleracea 15g. A total of 14 doses. To nourish the kidneys, clear the heart, invigorate the spleen, and promote digestion.

[0338] Usage: One dose per day, decocted in water and taken warm; Dosage: 100mL, twice a day.

[0339] Case 4

[0340] Guo XX; Gender: Male; Age: 5 years and 6 months; Date of initial consultation: November 17, 2024 (Figure 9)

[0341] Chief complaint: Generalized erythema, desquamation, and itching for 5 years, with recurrence and worsening for 2 weeks.

[0342] Present Illness: The patient developed a rash all over their body from childhood, accompanied by itching. The rash gradually increased in number. They sought medical attention at a local hospital and were diagnosed with "atopic dermatitis." Oral antihistamines and traditional Chinese medicine, along with topical tacrolimus and mupirocin ointment, were prescribed with limited effectiveness and the condition recurred frequently. One week ago, the condition worsened, with widespread red patches and papules appearing on the head, neck, trunk, and limbs, along with scratch marks, blood crusts, and nausea. Constipation was also reported. EASI: 12.2. NRS scores: pruritus 6, sleep VAS 6.

[0343] Past medical history: None. Family history: Mother has a history of allergic rhinitis. Allergy history: None.

[0344] Physical examination: Red patches and papules, scratch marks, and blood crusts on the head, neck, trunk, and limbs. Red tongue with a thick white coating. Slippery pulse.

[0345] Diagnosis: Western medicine: Atopic dermatitis (moderate); Traditional Chinese medicine: Four-sided wind-heat syndrome of the heart and spleen.

[0346] Prescription and treatment: 20g Rehmannia glutinosa, 8g Gardenia jasminoides, 12g Crataegus pinnatifida, 12g Massa fermentata, 8g Scutellaria baicalensis, 8g Isatis indigotica, 12g Hordeum vulgare, 10g Raphanus sativus, 10g Paeonia lactiflora, 10g Dictamnus dasycarpus root bark. 14 doses in total. To nourish the kidneys, clear the heart, invigorate the spleen, and promote digestion.

[0347] Usage: One dose per day, decocted in water and taken warm; Dosage: 100mL, twice daily.

[0348] Follow-up appointment date: November 30, 2024

[0349] Present Illness: Follow-up visit for Alzheimer's disease. Itching and sleep have significantly decreased. EASI: 6.2. VAS score: Itching 3 points, sleep 3 points. A few red patches on the face and limbs, generalized erythema, scratch marks and scabs have decreased, and there is minor epidermal erosion. Appetite is good, bowel movements are normal.

[0350] Physical examination: A few red patches on the face and limbs, generalized erythema, scratch marks and scabs reduced, minor epidermal erosion. Pale red tongue with white coating. Slippery pulse.

[0351] Diagnosis: Western medicine: Atopic dermatitis (mild); Traditional Chinese medicine: Four-sided wind-heat accumulation syndrome of the heart and spleen.

[0352] Prescription and treatment: Rehmannia glutinosa 15g, Gardenia jasminoides 8g, Crataegus pinnatifida 12g, Massa fermentata 12g, Scutellaria baicalensis 8g, Isatis indigotica 8g, Hordeum vulgare 12g, Raphanus sativus 10g, Paeonia lactiflora 10g, Dictamnus dasycarpus 6g. 14 doses in total. To nourish the kidneys, clear the heart, invigorate the spleen, and promote digestion.

[0353] Usage: One dose per day, decocted in water and taken warm; Dosage: 100mL, twice a day.

[0354] Follow-up appointment date: December 12, 2024 (Figure 10)

[0355] Present illness: Follow-up visit for Alzheimer's disease; itching relieved, rash subsided. EASI: 0.2. VAS score: itching 0, sleep 0. Appetite normal, bowel movements regular.

[0356] Physical examination: Minor pigmentation. Red tongue with white coating. Slippery pulse.

[0357] Diagnosis: Western medicine: Atopic dermatitis (mild); Traditional Chinese medicine: Four-sided wind-heat accumulation syndrome of the heart and spleen.

[0358] Prescription and treatment: Rehmannia glutinosa 10g, Gardenia jasminoides 4g, Crataegus pinnatifida 8g, Massa fermentata 8g, Scutellaria baicalensis 4g, Isatis indigotica 3g, Hordeum vulgare 8g, Raphanus sativus 5g, Paeonia lactiflora 5g, Dictamnus dasycarpus 5g. Continue maintenance treatment. Nourish the kidneys, clear the heart, invigorate the spleen, and promote digestion.

[0359] Usage: One dose per day, decocted in water and taken warm; Dosage: 100mL, twice daily.

[0360] Example 5:

[0361] Patient: Female, 12 years old; Date of visit: December 17, 2024 (Figure 11)

[0362] Chief complaint: Rash all over the body accompanied by itching for 8 years, worsening in the last 3 weeks.

[0363] Present Illness: Eight years ago, the patient developed a rash on their back and was diagnosed with atopic dermatitis at another hospital. Topical corticosteroids, tacrolimus, and antibiotic ointments were used, but the skin lesions fluctuated in severity. Three weeks ago, the rash worsened after staying up late. Current EASI score: 7.9. Pruritus NRS score: 8. Sleep VAS score: 6. Appetite is good; bowel movements occur every two days. Tongue is red with a white coating; pulse is slippery.

[0364] Past medical history: Allergic rhinitis; Allergy history: Pollen and dust mite allergies.

[0365] Physical examination: Multiple red and light red patches and papules on the head, face, and limbs, accompanied by scratch marks and blood crusts. Red tongue with white coating, and slippery pulse.

[0366] Diagnosis: Western medicine diagnosis: Atopic dermatitis (moderate); Traditional Chinese medicine diagnosis: Four-sided wind-heat accumulation syndrome of the heart and spleen.

[0367] Prescription and treatment: Rehmannia glutinosa 15g, Gardenia jasminoides 10g, Crataegus pinnatifida 10g, Massa fermentata 10g, Scutellaria baicalensis 10g, Isatis indigotica 10g, Hordeum vulgare 10g, Raphanus sativus 10g, Ostrea gigas 30g, Uncaria rhynchophylla 15g (added later). A total of 14 doses. To nourish water, clear the heart, and promote bowel movement.

[0368] Usage: One dose per day, decocted in water and taken warm; Dosage: 100mL, twice a day.

[0369] Follow-up visit 1: December 31, 2023 (Figure 12)

[0370] After two weeks of treatment, itching was significantly reduced, skin lesions were lighter in color, and scratch marks and scabs decreased. EASI score: 4.2. Pruritus NRS score: 4. Sleep VAS score: 3. Appetite was good, and bowel movements were once a day. Tongue was red with a white coating, and pulse was slippery.

[0371] Diagnosis: Western medicine diagnosis: Atopic dermatitis (mild); Traditional Chinese medicine diagnosis: Four-sided wind-heat accumulation syndrome of the heart and spleen.

[0372] Prescription: 20g Rehmannia glutinosa, 10g Gardenia jasminoides, 10g Crataegus pinnatifida, 10g Massa fermentata, 10g Scutellaria baicalensis, 15g Isatis indigotica, 10g Hordeum vulgare, 10g Raphanus sativus, 30g Ostrea gigas, and 15g Uncaria rhynchophylla (added later). 14 doses in total.

[0373] Usage: One dose per day, decocted in water and taken warm; Dosage: 100mL, twice a day.

[0374] Second follow-up visit: January 7, 2024 (Figure 13)

[0375] After 4 weeks of treatment, mild itching and most skin lesions subsided. EASI score: 0.4. Pruritus NRS score: 1. Sleep VAS score: 0. Appetite: normal, bowel movements once a day. Tongue: red, coating: white, pulse: slippery.

[0376] Diagnosis: Western medicine diagnosis: Atopic dermatitis (mild); Traditional Chinese medicine diagnosis: Four-sided wind-heat accumulation syndrome of the heart and spleen.

[0377] Prescription: 12g Rehmannia glutinosa, 6g Gardenia jasminoides, 10g Crataegus pinnatifida, 10g Massa fermentata, 6g Scutellaria baicalensis, 5g Isatis indigotica, 10g Hordeum vulgare, 10g Radish seed, 20g Ostrea gigas, 10g Uncaria rhynchophylla (added later). 14 doses in total.

[0378] Usage: One dose per day, decocted in water and taken warm; Dosage: 100mL, twice a day.

[0379] Example 6:

[0380] Patient: Male, 9 years old

[0381] Date of visit: December 17, 2024 (Figures 14 and 15)

[0382] Chief complaint: Rash all over the body accompanied by itching for 5 years, worsening in the past 2 weeks.

[0383] Present Illness: Five years ago, the patient developed a rash on their back and was diagnosed with atopic dermatitis at another hospital. Topical corticosteroids and antibiotic ointments were used, but the rash fluctuated in severity. Two weeks ago, the rash worsened after consuming snacks. Current EASI score: 14.5. Pruritus NRS score: 7. Sleep VAS score: 6. Appetite is good; bowel movements occur every two days. Tongue is red with a thick white coating; pulse is slippery.

[0384] Past medical history: Allergic rhinitis; Allergy history: Dust mite allergy.

[0385] Physical examination: Multiple red patches and papules on the limbs, accompanied by significant epidermal erosion, mild erosion and exudation, blood crusts, and scratch marks. The tongue is red with a white and greasy coating, and the pulse is slippery.

[0386] Diagnosis: Western medicine diagnosis: Atopic dermatitis (moderate); Traditional Chinese medicine diagnosis: Four-sided wind-heat accumulation syndrome of the heart and spleen.

[0387] Prescription and treatment: 20g Rehmannia glutinosa, 5g Coptis chinensis, 15g Crataegus pinnatifida, 15g Massa fermentata, 12g Atractylodes lancea, 10g Isatis indigotica, 10g Raphanus sativus, 10g Dictamnus dasycarpus, 30g Lonicera japonica. 14 doses in total. To nourish water, clear the heart, and promote bowel movement.

[0388] Usage: One dose per day, decocted in water and taken warm; Dosage: 100mL, twice a day.

[0389] Follow-up visit 1: December 31, 2023

[0390] After two weeks of treatment, itching was significantly reduced, skin lesions partially subsided, and erosion and exudation were significantly reduced. A few scattered red patches and papules, a few scratch marks and blood scabs were observed on the limbs. EASI score: 8.3. Pruritus NRS score: 4. Sleep VAS score: 3. Appetite was good, bowel movements were once a day. Tongue was red with a white coating, and pulse was slippery.

[0391] Diagnosis: Western medicine diagnosis: Atopic dermatitis (moderate); Traditional Chinese medicine diagnosis: Four-sided wind-heat accumulation syndrome of the heart and spleen.

[0392] Prescription: 15g Rehmannia glutinosa, 3g Coptis chinensis, 15g Crataegus pinnatifida, 15g Massa fermentata, 10g Atractylodes lancea, 10g Isatis indigotica, 10g Raphanus sativus, 10g Dictamnus dasycarpus, 20g Lonicera japonica. 14 doses in total.

[0393] Usage: One dose per day, decocted in water and taken warm; Dosage: 100mL, twice a day.

[0394] Second follow-up visit: January 7, 2024 (Figure 16)

[0395] After 4 weeks of treatment, mild itching persisted, and most skin lesions subsided. A very small number of red papules, a few scratch marks, and blood scabs remained scattered on the trunk and limbs. EASI score: 1.2. Pruritus NRS score: 1. Sleep VAS score: 0. Appetite was good, and bowel movements occurred once daily. Tongue was red with a white coating, and pulse was slippery.

[0396] Diagnosis: Western medicine diagnosis: Atopic dermatitis (mild); Traditional Chinese medicine diagnosis: Four-sided wind-heat accumulation syndrome of the heart and spleen.

[0397] Prescription: 15g Rehmannia glutinosa, 3g Coptis chinensis, 15g Crataegus pinnatifida, 15g Massa fermentata, 10g Atractylodes lancea, 10g Isatis indigotica, 10g Raphanus sativus, 5g Dictamnus dasycarpus, 10g Lonicera japonica. 14 doses in total.

[0398] Usage: One dose per day, decocted in water and taken warm; Dosage: 100mL, twice a day.

[0399] Example 7:

[0400] Patient: Male, 11 years old; Date of visit: July 30, 2024 (Figure 17)

[0401] Chief complaint: Erythema and papules with itching on the limbs for 1 year, worsening in the past week.

[0402] Present Illness: One year ago, the patient developed a rash after an insect bite, which recurred and gradually spread to the extremities. An external hospital diagnosed it as atopic dermatitis. Topical corticosteroids and antibiotic ointments were used, but the skin lesions fluctuated in severity. One week ago, the rash worsened again. Currently, scattered red patches, papules, and nodules are present on the extremities. EASI score: 10.6. Pruritus NRS score: 7. Sleep VAS score: 6. Appetite is good; bowel movements occur every two days. Tongue is red with a thick white coating; pulse is slippery.

[0403] Past medical history: Allergic rhinitis; Allergy history: Pollen allergy.

[0404] Physical examination: Multiple red patches, papules, and nodules on the limbs, accompanied by scratch marks and blood crusts. Red tongue with a white, greasy coating, and slippery pulse.

[0405] Diagnosis: Western medicine diagnosis: Atopic dermatitis (moderate); Traditional Chinese medicine diagnosis: Four-sided wind-heat accumulation syndrome of the heart and spleen.

[0406] Prescription and treatment: 20g Rehmannia glutinosa, 5g Coptis chinensis, 20g Crataegus pinnatifida, 20g Massa fermentata, 15g Atractylodes lancea, 10g Isatis indigotica, 10g Raphanus sativus, 12g Dictamnus dasycarpus, 30g Ostrea gigas. 14 doses in total. To nourish yin, clear the heart, and promote bowel movement.

[0407] Usage: One dose per day, decocted in water and taken warm; Dosage: 100mL, twice a day.

[0408] Follow-up visit 1: December 31, 2023 (Figure 18)

[0409] After two weeks of treatment, itching significantly decreased, skin lesions gradually flattened and shrank, and scratch marks and scabs lessened. A few scattered red patches, nodules, and papules, along with a few scratch marks and scabs, were observed on the limbs. EASI score: 7.3. Pruritus NRS score: 4. Sleep VAS score: 3. Appetite was good, and bowel movements occurred once daily. Tongue was red with a white coating, and pulse was slippery.

[0410] Diagnosis: Western medicine diagnosis: Atopic dermatitis (moderate); Traditional Chinese medicine diagnosis: Four-sided wind-heat accumulation syndrome of the heart and spleen.

[0411] Prescription: 15g Rehmannia glutinosa, 3g Coptis chinensis, 20g Crataegus pinnatifida, 20g Massa fermentata, 12g Atractylodes lancea, 10g Isatis indigotica, 10g Raphanus sativus, 12g Dictamnus dasycarpus, 30g Ostrea gigas. 14 doses in total.

[0412] Usage: One dose per day, decocted in water and taken warm; Dosage: 100mL, twice a day.

[0413] Second follow-up visit: January 7, 2024 (Figure 19)

[0414] After 4 weeks of treatment, mild itching and partial resolution of skin lesions were observed. A few scattered red nodules and papules, along with a few scratch marks and scabs, were visible on the extremities. EASI score: 3.6. Pruritus NRS score: 2. Sleep VAS score: 0. Appetite was good, and bowel movements were once daily. Tongue was red with a white coating, and the pulse was slippery.

[0415] Diagnosis: Western medicine diagnosis: Atopic dermatitis (mild); Traditional Chinese medicine diagnosis: Four-sided wind-heat accumulation syndrome of the heart and spleen.

[0416] Prescription: 15g Rehmannia glutinosa, 3g Coptis chinensis, 20g Crataegus pinnatifida, 20g Massa fermentata, 10g Atractylodes lancea, 8g Isatis indigotica, 10g Raphanus sativus, 10g Dictamnus dasycarpus, 20g Ostrea gigas. 14 doses in total.

[0417] Usage: One dose per day, decocted in water and taken warm; Dosage: 100mL, twice a day.

Claims

1. A traditional Chinese medicine composition, said traditional Chinese medicine composition comprising the following traditional Chinese medicines in parts by weight: The principal ingredient is selected from one or more of the following: 5-20 parts of Coptis chinensis, 5-50 parts of Rehmannia glutinosa, and / or 2-30 parts of Gardenia jasminoides. The herb is selected from one or more of the following: 5-30 parts hawthorn and / or 5-30 parts medicated leaven; The adjuvant herbs are selected from one or more of the following: Uncaria rhynchophylla 5-20 parts, Portulaca oleracea 10-90 parts, Atractylodes lancea 5-30 parts, Lonicera japonica 5-60 parts, Paeonia lactiflora 5-30 parts, Isatis indigotica 5-30 parts, Hordeum vulgare 5-30 parts, Dictamnus dasycarpus 5-30 parts, Ostrea gigas 5-45 parts, Scutellaria baicalensis 2-20 parts and / or Lophatherum gracile 2-20 parts. The medicine is selected from one or more of the following: 2-30 parts of Citrus aurantium and / or 2-15 parts of Raphanus sativus and / or 2-10 parts of Areca catechu.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, The traditional Chinese medicine composition consists of the following traditional Chinese medicines in parts by weight: The principal ingredient is selected from one or more of the following: 5-12 parts of Coptis chinensis, 5-30 parts of Rehmannia glutinosa, and / or 2-20 parts of Gardenia jasminoides. The herb is selected from one or more of hawthorn (5-20 parts) and / or medicated leaven (5-20 parts); The adjuvant herbs are selected from one or more of the following: Uncaria rhynchophylla 5-15 parts, Portulaca oleracea 10-60 parts, Atractylodes lancea 5-20 parts, Lonicera japonica 5-40 parts, Paeonia lactiflora 5-20 parts, Isatis indigotica 5-25 parts, Hordeum vulgare 5-20 parts, Dictamnus dasycarpus 5-20 parts, Ostrea gigas 5-30 parts, Scutellaria baicalensis 2-12 parts and / or Lophatherum gracile 2-15 parts. The medicine is selected from one or more of the following: 2-20 parts of Citrus aurantium and / or 2-10 parts of Raphanus sativus and / or 2-8 parts of Areca catechu.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following traditional Chinese medicines in parts by weight: The principal ingredient is selected from one or more of the following: 5-10 parts of Coptis chinensis, 5-25 parts of Rehmannia glutinosa, and / or 2-10 parts of Gardenia jasminoides. The herb is selected from one or more of hawthorn (5-15 parts) and / or medicated leaven (5-15 parts); The adjuvant herbs are selected from one or more of the following: Uncaria rhynchophylla 5-10 parts, Portulaca oleracea 10-30 parts, Atractylodes lancea 5-15 parts, Lonicera japonica 5-30 parts, Paeonia lactiflora 5-15 parts, Isatis indigotica 5-20 parts, Hordeum vulgare 5-15 parts, Dictamnus dasycarpus 5-15 parts, Ostrea gigas 5-20 parts, Scutellaria baicalensis 2-10 parts and / or Lophatherum gracile 2-10 parts. The medicine is selected from one or more of the following: 2-10 parts of Citrus aurantium and / or 2-8 parts of Raphanus sativus and / or 2-6 parts of Areca catechu.

4. A traditional Chinese medicine preparation made from the traditional Chinese medicine composition as described in claim 1, characterized in that, The traditional Chinese medicine preparations are one or more of the following: ointment, pill, elixir, decoction, granule, capsule, powder, and / or tablet.

5. The traditional Chinese medicine preparation as described in claim 4, characterized in that, The preparation is a decoction, and the preparation method of the decoction includes the following steps: S01: Prepare the Chinese herbal raw materials according to the required proportions; S02: Soak the Chinese herbal medicine raw materials prepared in S01; S03: Boil the raw materials and soaking liquid several times; S04: Combine and concentrate the decoction obtained from several decoctions to obtain a decoction.

6. The traditional Chinese medicine preparation as described in claim 4, characterized in that, The traditional Chinese medicine preparation contains pharmaceutically acceptable excipients required for the corresponding preparation; the excipients are pharmaceutical excipients that enhance the efficacy, reduce toxicity, and / or alleviate the side effects of the main drug.

7. The use of the traditional Chinese medicine composition as described in claim 1 in the preparation of a medicament for treating skin diseases, characterized in that, The skin diseases mentioned include atopic dermatitis, eczema, dermatitis, allergic dermatitis, and psoriasis.

8. The application as described in claim 7, characterized in that, The skin condition described is atopic dermatitis.

9. The application as described in claim 7, characterized in that, The atopic dermatitis mentioned is a syndrome of accumulated heat in the heart and spleen.

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