Ginseng and Licorice Root Formula for Treating Renal Hematuria, its Preparation Method and Application

Abstract

This invention belongs to the field of traditional Chinese medicine, specifically relating to a ginseng and licorice root formula for treating renal hematuria, its preparation method, and its application. The ginseng and licorice root formula for treating renal hematuria of this invention comprises the following raw materials in parts by weight: 5-15 parts of Codonopsis pilosula, 15-30 parts of Rehmannia glutinosa, 5-15 parts of Ligustrum lucidum, 5-15 parts of Eclipta prostrata, 5-15 parts of Imperata cylindrica, 5-15 parts of Rubia cordifolia, 5-15 parts of Cirsium japonicum, 5-15 parts of Taraxacum mongolicum, 5-8 parts of Prunus persica, and 3-5 parts of Glycyrrhiza uralensis. Clinical trials have shown that the ginseng and licorice root formula for treating renal hematuria of this invention not only reduces urinary red blood cells but also improves traditional Chinese medicine clinical symptoms such as lower back and knee weakness, fixed or stabbing lower back pain, pale complexion, fatigue, dry mouth, bitter taste, sore throat, rough skin, and poor appetite. It has good therapeutic effects, reliable safety, and can significantly improve the treatment efficacy of chronic nephritis syndrome.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, specifically relating to a ginseng and licorice root formula for treating renal hematuria, its preparation method, and its application. Background Technology

[0002] Renal hematuria is caused by coagulation disorders, ischemia, hypoxia, and immune dysfunction, leading to glomerular damage and basement membrane rupture. This results in red blood cells leaking through the glomerular filtration membrane and being excreted in the urine, primarily manifesting as microscopic and gross hematuria. Microscopic hematuria is characterized by three or more red blood cells per high-power field in urine sediment examined under a microscope. Renal hematuria is characterized by a prolonged course and a high recurrence rate. Currently, Western medicine primarily treats simple renal hematuria through observation, lacking specific drug treatments.

[0003] Traditional Chinese medicine (TCM) possesses unique advantages in treating renal hematuria and related diseases due to its multi-target efficacy and minimal side effects. The TCM preparation Shenyan Kangfu Pian (Nephritis Recovery Tablets) has shown some efficacy in improving clinical symptoms and reducing proteinuria in nephritis patients, and is frequently used clinically to treat renal hematuria. However, clinical application has revealed that the therapeutic effect of Shenyan Kangfu Pian on renal hematuria is not entirely ideal. Therefore, it is necessary to develop a TCM composition that can effectively treat renal hematuria to meet clinical needs. Summary of the Invention

[0004] The first objective of this invention is to provide a ginseng and licorice root formula for treating renal hematuria; the second objective of this invention is to provide a method for preparing the ginseng and licorice root formula; and the third objective of this invention is to provide an application of the ginseng and licorice root formula.

[0005] According to a first aspect of the present invention, a formula for treating renal hematuria is provided, the effective ingredients of which include the following raw materials in parts by weight: 5-15 parts of Codonopsis pilosula, 15-30 parts of Rehmannia glutinosa, 5-15 parts of Ligustrum lucidum, 5-15 parts of Eclipta prostrata, 5-15 parts of Imperata cylindrica, 5-15 parts of Rubia cordifolia, 5-15 parts of Cirsium japonicum, 5-15 parts of Taraxacum mongolicum, 5-8 parts of Prunus persica, and 3-5 parts of Glycyrrhiza uralensis.

[0006] This invention posits that renal hematuria is consistently caused by qi deficiency throughout the course of the disease, with damp-heat and blood stasis being key factors contributing to its progression or prolonged, intractable nature. Prolonged illness depletes qi and damages yin, ultimately leading to both qi and yin deficiency. Therefore, this invention employs a formula based on the principles of tonifying qi and nourishing yin, clearing heat and promoting diuresis, and invigorating blood circulation and removing blood stasis.

[0007] In this formula, Codonopsis pilosula is the chief herb. Codonopsis pilosula is known for its ability to clear heat and nourish yin, and it also benefits qi.

[0008] The three herbs Rehmannia glutinosa, Ligustrum lucidum, and Eclipta prostrata are used together to nourish the kidneys and yin. Rehmannia glutinosa clears heat, nourishes yin, cools the blood and stops bleeding. Ligustrum lucidum and Eclipta prostrata are used together to enhance the effect of nourishing yin and tonifying the kidneys, soothe the five internal organs, and effectively relieve patients' symptoms of soreness and weakness in the waist and knees, fatigue and weakness, and dry mouth. It can also clear heat and stop bleeding.

[0009] The three herbs, Imperata cylindrica root, Rubia cordifolia root, and Cirsium japonicum, are used together to cool the blood and stop bleeding without leaving blood stasis. Imperata cylindrica root can clear heat and promote diuresis, guide heat downward, and promote the removal of damp heat from the lower jiao. Rubia cordifolia root is good at moving through the blood, both stopping bleeding and removing blood stasis, which is especially suitable for those with blood heat and blood stasis. Cirsium japonicum root can stop bleeding and also promote blood circulation and detoxify, which is suitable for those with damp heat and turbid toxins stagnation accompanied by hematuria.

[0010] Dandelion has a bitter taste and can detoxify and promote urination, allowing dampness and toxins to be excreted through urine. It can also reduce swelling and dissipate nodules. Upper respiratory tract infection is a common cause of renal hematuria. Symptoms of upper respiratory tract infection include sore throat and swollen tonsils. Dandelion can improve the treatment effect of tonsillitis. At the same time, although dandelion is cold in nature and can clear heat, it does not harm the earth element and can prevent damage to the stomach yin.

[0011] Peach kernels invigorate blood circulation, remove blood stasis, and moisten the intestines to relieve constipation. This invention believes that blood stasis persists throughout renal hematuria, making the removal of blood stasis particularly important. Although the formula already contains madder root and small thistle to remove blood stasis, they are cold in nature, while peach kernels are neutral in nature and have a strong blood-activating effect without harming yang. Therefore, peach kernels are added. At the same time, long-term renal hematuria depletes yin and damages body fluids, leading to dry stools. Peach kernels can assist in relieving constipation. By using peach kernels, dampness, turbidity, and toxins can be expelled with the stool.

[0012] Licorice is neutral in nature and has a mild medicinal effect. It harmonizes cold and heat, regulates ascending and descending, and is mainly used to harmonize the effects of various medicines.

[0013] Overall, the prescription uses light and gentle herbs with mild properties. When used together, the herbs work synergistically to invigorate qi and nourish yin, clear heat and promote diuresis, and resolve blood stasis and stop bleeding.

[0014] The raw materials for this invention are sourced as follows:

[0015] Prince Ginseng: The dried tuberous root of Pseudostellaria heterophylla (Miq.) Pax ex Paxet Hoffm., a plant in the Caryophyllaceae family.

[0016] Rehmannia: The fresh or dried tuberous root of Rehmannia anniaglutinosa Libosch., a plant of the Scrophulariaceae family.

[0017] Privet fruit: the fruit of Ligustrum lucidum Ait., a plant in the Oleaceae family.

[0018] Eclipta prostrata L., a plant belonging to the genus Eclipta in the family Asteraceae.

[0019] Imperata cylindrica root: The rhizome of Imperata cylindrica Beauv. var. major (Nees) CE Hubb., a plant in the Poaceae family.

[0020] Madder: The root and rhizome of Rubia cordifolia L., a plant in the Rubiaceae family.

[0021] Small thistle: The above-ground parts of Cirsium setosum (Willd.) MB., a plant belonging to the genus Cirsium in the family Asteraceae.

[0022] Dandelion: The dried whole herb of *Taraxacum mongolicum* Hand.Mazz., *T. sinicum* Kitag., or several other species in the same genus of the Asteraceae family.

[0023] Peach kernel: The dried, mature seeds of the Rosaceae plants Prunus persica (L.) Batsch or Prunus davidiana (Carr.) Franch.

[0024] Licorice: The dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L., plants belonging to the genus Glycyrrhiza in the legume family.

[0025] In some embodiments, to make the ginseng and herb root formula of the present invention suitable for more patients, at least one of the following raw materials in parts by weight may be added to the ginseng and herb root formula of the present invention: 5-15 parts of Codonopsis pilosula, 5-15 parts of Atractylodes macrocephala, 5-15 parts of Dioscorea opposita, 5-15 parts of Crataegus pinnatifida, 5-15 parts of germinated rice, 5-15 parts of malt, 5-15 parts of Dendrobium nobile, 5-15 parts of Ophiopogon japonicus, 5-15 parts of Agrimonia pilosa, and 5-15 parts of Callicarpa macrophylla. 5-15 parts of the following herbs: Herb, Oldenlandia diffusa, Carthamus tinctorius, Salvia miltiorrhiza, Panax notoginseng, Ligusticum chuanxiong, Lonicera japonica, Forsythia suspensa, Mentha haplocalyx, Dipsacus asper, Cibotium barometz, Ephedra sinica root, Triticum aestivum, Cinnamomum cassia twig, Poria cocos, and Coix lacryma-jobi.

[0026] Generally, for patients with renal hematuria, if the patient is fatigued and weak with obvious qi deficiency, Codonopsis pilosula, Atractylodes macrocephala, and / or Dioscorea opposita can be added; if the patient has poor appetite, Crataegus pinnatifida, germinated barley, and / or malt can be added; if the patient has dry mouth with obvious yin deficiency, Dendrobium nobile and / or Ophiopogon japonicus can be added; if the patient has obvious hematuria, Agrimonia pilosa and / or Callicarpa japonica can be added; if the patient has bitter taste in the mouth with obvious damp-heat, Hedyotis diffusa can be added; if the patient has a dark red tongue with petechiae and obvious blood stasis, Carthamus tinctorius, Salvia miltiorrhiza, Panax notoginseng, and / or Ligusticum chuanxiong can be added; if the patient has sore throat or throat discomfort, or has external symptoms, Lonicera japonica, Forsythia suspensa, and / or Mentha haplocalyx can be added; if the patient has lower back pain, Dipsacus asper and / or Cibotium barometz can be added; if the patient has spontaneous sweating and weak exterior syndrome, Ephedra sinica root, Triticum aestivum, and / or Cinnamomum cassia can be added; if the patient has facial and limb edema, Poria cocos and / or Coix lacryma-jobi can be added.

[0027] In some implementations, pharmaceutically acceptable excipients may also be added.

[0028] In some implementations, the dosage form of the ginseng and licorice root formula is a decoction, granules, tablets, oral liquid, ointment, powder, pills, or capsules.

[0029] According to a second aspect of the present invention, a method for preparing the above-mentioned ginseng and licorice root formula for treating renal hematuria is provided. When the dosage form of the ginseng and licorice root formula is a decoction, the preparation method includes the following steps:

[0030] Weigh the raw materials according to the formula, soak them in 4-8 times their weight of water for 15-30 minutes, then heat to boiling and keep simmering for 1-2 hours. Filter and collect the filtrate.

[0031] According to a third aspect of the present invention, the use of the above-described ginseng and licorice root formula for treating renal hematuria in the preparation of a medicament for treating renal hematuria is provided. Specifically, renal hematuria is renal hematuria caused by chronic glomerulonephritis and / or IgA nephropathy and / or purpuric nephritis and / or lupus nephritis.

[0032] According to a fourth aspect of the present invention, the above-described ginseng and licorice root formula for treating renal hematuria is provided for use in the preparation of a medicament for treating chronic nephritis syndrome.

[0033] The beneficial effects of this invention include:

[0034] Clinical trials have shown that the ginseng and licorice root formula of this invention for treating renal hematuria can not only reduce red blood cells in urine, but also improve traditional Chinese medicine clinical symptoms such as soreness and weakness of the lower back and knees, fixed or stabbing lower back pain, pale complexion, fatigue, dry mouth, bitter taste, sore throat, rough skin, and poor appetite. It has good therapeutic effect and reliable safety, and can significantly improve the treatment efficacy of chronic nephritis syndrome. Attached Figure Description

[0035] Figure 1 This is a technical roadmap for the clinical trials of this invention.

[0036] Figure 2 This is a flowchart illustrating the inclusion of cases in the clinical trials of this invention. Detailed Implementation

[0037] The present invention will be further described in detail below with reference to specific embodiments, but the implementation of the present invention is not limited thereto. The materials involved in the following embodiments are all commercially available.

[0038] Example 1

[0039] The preparation method of the ginseng and licorice root decoction for treating renal hematuria in this embodiment includes the following steps:

[0040] (1) Weigh out 10g of Codonopsis pilosula, 15g of Rehmannia glutinosa, 15g of Ligustrum lucidum, 15g of Eclipta prostrata, 15g of Imperata cylindrica, 10g of Rubia cordifolia, 10g of Cirsium japonicum, 10g of Taraxacum mongolicum, 5g of Prunus persica, and 3g of Glycyrrhiza uralensis.

[0041] (2) First, soak the above raw materials in about 600 mL of cold water for 30 minutes, then heat to boiling, keep it simmering for 1.5 hours, filter, and obtain about 160 mL of filtrate.

[0042] The herbal decoction prepared in this embodiment is a single dose, approximately 160 mL. One dose is taken daily, around 10 AM.

[0043] Example 2

[0044] The preparation method of the ginseng and licorice root decoction for treating renal hematuria in this embodiment is similar to that in Example 1. The difference is that in step (1), 10g of Codonopsis pilosula, 25g of Rehmannia glutinosa, 10g of Ligustrum lucidum, 10g of Eclipta prostrata, 10g of Imperata cylindrica, 10g of Rubia cordifolia, 10g of Cirsium japonicum, 10g of Taraxacum mongolicum, 7g of Prunus persica, and 4g of Glycyrrhiza uralensis are weighed.

[0045] The traditional Chinese medicine decoction prepared in this embodiment is a single dose, which is approximately 160 mL.

[0046] Example 3

[0047] The preparation method of the ginseng and licorice root decoction for treating renal hematuria in this embodiment is similar to that in Example 1. The difference is that in step (1), 15g of Codonopsis pilosula, 30g of Rehmannia glutinosa, 15g of Ligustrum lucidum, 5g of Eclipta prostrata, 15g of Imperata cylindrica, 5g of Rubia cordifolia, 5g of Cirsium japonicum, 5g of Taraxacum mongolicum, 5g of Prunus persica, and 3g of Glycyrrhiza uralensis are weighed.

[0048] The traditional Chinese medicine decoction prepared in this embodiment is a single dose, which is approximately 160 mL.

[0049] Example 4

[0050] The preparation method of the ginseng and licorice root decoction for treating renal hematuria in this embodiment is similar to that in Example 1. The difference is that in step (1), 5g of Codonopsis pilosula, 15g of Rehmannia glutinosa, 5g of Ligustrum lucidum, 15g of Eclipta prostrata, 5g of Imperata cylindrica, 15g of Rubia cordifolia, 15g of Cirsium japonicum, 15g of Taraxacum mongolicum, 8g of Prunus persica, and 5g of Glycyrrhiza uralensis are weighed.

[0051] The traditional Chinese medicine decoction prepared in this embodiment is a single dose, which is approximately 160 mL.

[0052] To investigate the efficacy and safety of the ginseng and licorice root formula for treating renal hematuria of the present invention, the following clinical trials were conducted.

[0053] I. Research Methods

[0054] This retrospective study included 73 outpatients diagnosed with chronic nephritis syndrome by Western medicine and hematuria by traditional Chinese medicine from October 1, 2021 to October 1, 2023, with the syndrome pattern of Qi and Yin deficiency and damp-heat stagnation. Based on the use of Shencao Genfang (a traditional Chinese medicine formula) and Shenyan Kangfu Pian (a traditional Chinese medicine formula for nephritis), patients were divided into a Shencao Genfang group (basic treatment + Shenyan Kangfu Pian + Shencao Genfang) and a control group (basic treatment + Shenyan Kangfu Pian) (n=35). Baseline data of both groups were analyzed in a cross-sectional study, and longitudinal data were analyzed starting from the baseline time point. Data from the electronic outpatient and inpatient systems of both groups of patients were followed up. The follow-up endpoints were the end of the second course of treatment, doubling of serum creatinine or progression to end-stage renal disease, and doubling of transaminase levels. Data from the two groups at baseline and at the end of the second course of treatment were analyzed and compared, including primary outcome measures: TCM efficacy assessment (TCM symptom score) and Western medicine efficacy assessment (urine red blood cell count and urine microscopic red blood cell count); secondary outcome measures: alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine, blood urea nitrogen, and adverse events, to evaluate the clinical efficacy and safety of the Shencao Genfang formula in treating renal hematuria.

[0055] The technical roadmap of this study is as follows: Figure 1 As shown.

[0056] II. Research Subjects

[0057] From October 1, 2021 to October 1, 2023, the outpatient was diagnosed with chronic nephritis syndrome by Western medicine and hematuria by traditional Chinese medicine, with the syndrome type being Qi and Yin deficiency and damp-heat stagnation.

[0058] III. Diagnostic Criteria

[0059] (I) Western Medicine Diagnostic Criteria

[0060] 1. Persistent or recurrent microscopic hematuria and / or intermittent gross hematuria, with more than 3 red blood cells per high-power field in centrifuged fresh urine sediment;

[0061] 2. Urine red blood cell phase: ≥75% abnormal red blood cells in urine, or accompanied by red blood cell casts, for more than 3 consecutive times;

[0062] 3. Exclude acute post-infectious glomerulonephritis, secondary glomerulonephritis, and hereditary kidney diseases.

[0063] The diagnostic criteria were formulated with reference to the relevant content in "Nephrology" edited by Wang Haiyan and the 2009 edition of the Chinese Medical Association's "Clinical Practice Guidelines for Nephrology".

[0064] (II) Traditional Chinese Medicine Diagnostic Criteria

[0065] 1. Qi and Yin Deficiency Syndrome:

[0066] Main symptoms: fatigue, easy to catch colds, pale complexion, shortness of breath, pale red or red tongue, and weak pulse.

[0067] Secondary symptoms: dry mouth and throat or dark red throat.

[0068] 2. Blood stasis syndrome:

[0069] Main symptoms: chronic illness, fixed or stabbing lower back pain, dark or dull complexion, rough and dry skin, purplish (pale) dark tongue or with petechiae or ecchymosis, tortuous and bluish-purple sublingual veins, and thready and hesitant pulse.

[0070] Secondary symptoms: numbness in the limbs and difficulty urinating.

[0071] 3. Damp-heat syndrome:

[0072] Main symptoms: sore throat, bitter or dry mouth, abdominal distension and poor appetite, dark yellow or burning urine.

[0073] Secondary symptoms: The tongue coating is slightly yellow or yellow, and the pulse is soft and rapid or slippery and rapid.

[0074] The diagnostic criteria were based on the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" issued in 2002.

[0075] IV. Inclusion Criteria

[0076] 1. Meets the above-mentioned diagnostic criteria in both traditional Chinese medicine and Western medicine and has at least one follow-up examination result;

[0077] 2. Microscopic red blood cell count ≥10 / HP;

[0078] 3. No proteinuria or with a small amount of proteinuria (urine protein quantification <1g / d);

[0079] 4. Age between 18 and 75 years old;

[0080] 5. Normal kidney function, creatinine level <81umol / L for women and <111umol / L for men (according to the local hospital's testing standards).

[0081] V. Exclusion Criteria

[0082] 1. The patient has secondary causes (including urinary tract stones, tumors, tuberculosis, etc.); physiological hematuria (such as after strenuous exercise);

[0083] 2. Pregnant women (or women planning to become pregnant) or breastfeeding women;

[0084] 3. Patients with acute infections, tumors, or serious diseases of the heart, brain, liver, hematopoietic system, or mental illness;

[0085] 4. Those who have taken hormones or immunosuppressants within the past month;

[0086] 5. Those with incomplete medical records.

[0087] VI. Elimination Criteria

[0088] 1. Those who fail to follow medical advice when taking medication, or whose treatment efficacy is unclear, thus interfering with the determination of treatment efficacy;

[0089] 2. Individuals with allergic reactions to the drug studied in this study.

[0090] VII. Sample Size Estimation

[0091] Since there is no prior clinical and reference data available, this retrospective study will collect cases through previous clinical records, and it is expected to collect at least 30 cases each from the Shencao Genfang group (basic treatment + nephritis recovery tablets + Shencao Genfang) and the control group (basic treatment + nephritis recovery tablets).

[0092] VIII. Treatment

[0093] (I) Basic Treatment

[0094] 1. All patients received routine health education: avoid overexertion, maintain emotional well-being, prevent colds, and eat a light diet; avoid using nephrotoxic drugs;

[0095] 2. Comorbid hypertension: Low-salt diet, use ARB or ACEI antihypertensive drugs, and if necessary, calcium channel blockers (CCB) can be added or other effective antihypertensive drugs can be used. Blood pressure should be controlled at <140 / 90 mmHg, and some patients need to control it below 130 / 80 mmHg.

[0096] 3. Comorbid diabetes: Diabetic diet, regular blood glucose monitoring, and active adjustment of blood glucose control plan according to blood glucose, blood glucose control: fasting blood glucose control at 3.3-6.1mmol / L, 2h postprandial blood glucose <7.8mmol / L;

[0097] 4. Complications include edema: a low-salt diet, fluid restriction if necessary, and appropriate use of diuretics (such as furosemide);

[0098] 5. Comorbid hyperlipidemia: For patients with predominantly high triglycerides, fibrates or niacin (such as fenofibrate) should be selected; for patients with predominantly high cholesterol, statins (such as atorvastatin calcium tablets) should be selected.

[0099] (II) Group Treatment

[0100] 1. Control group: Basic treatment combined with Nephritis Recovery Tablets (drug composition: ginseng, American ginseng, salvia miltiorrhiza, oldenlandia diffusa, eucommia ulmoides (fried), alisma plantago-aquatica, black bean, rehmannia glutinosa, smilax glabra, imperata cylindrica, leonurus japonicus, yam, platycodon grandiflorus, produced by Tianjin Tongrentang Group Co., Ltd., approval number: National Medicine Approval Number Z10940034, specification: 0.48g×45 tablets / bottle, 5 tablets orally 3 times a day, 1 course of treatment is 15 days, 2 courses of treatment in total).

[0101] 2. Ginseng and Herbal Root Formula Group: Basic treatment, Nephritis Recovery Tablets (composition: ginseng, American ginseng, salvia miltiorrhiza, oldenlandia diffusa, eucommia (fried), alisma plantago-aquatica, black bean, rehmannia glutinosa, smilax glabra, imperata cylindrica, motherwort, yam, platycodon grandiflorus, produced by Tianjin Tongrentang Group Co., Ltd., approval number: National Medicine Approval Number Z10940034, specification: 0.48g×45 tablets / bottle, 5 tablets orally 3 times a day, 1 course of treatment is 15 days, 2 courses in total) combined with Ginseng and Herbal Root Formula (Ginseng and Herbal Root Decoction prepared in Example 1, one dose per day, taken at around 10 am, 1 course of treatment is 15 days, 2 courses in total).

[0102] IX. Clinical Indicators

[0103] (I) Therapeutic indicators

[0104] 1. Laboratory indicators: Record the red blood cell count in urine microscopy and the red blood cell count in urine sediment once before and once after treatment; record the red blood cell phase in urine once before treatment.

[0105] 2. Traditional Chinese Medicine Symptom Scoring: The patient's symptoms (lower back and knee weakness, fixed or stabbing lower back pain, pale complexion, fatigue, dry mouth, bitter taste, rough skin, sore throat, poor appetite) were divided into four levels according to their presence and severity: none, mild, moderate, and severe, and represented by 0, 2, 4, and 6 points respectively. Tongue and pulse were not scored. The scores were recorded and statistically analyzed for both groups of patients before and after treatment.

[0106] (II) Safety Indicators

[0107] 1. Liver function: mainly recording alanine aminotransferase (ALT) and aspartate aminotransferase (AST).

[0108] 2. Kidney function: mainly records serum creatinine and blood urea nitrogen.

[0109] 3. Electrolytes: mainly record serum potassium.

[0110] 4. Complete blood count: mainly records hemoglobin.

[0111] (III) Evaluation of therapeutic efficacy

[0112] 1. Evaluation of the efficacy of Western medicine

[0113] (1) Clinical control: The red blood cell count in urine sediment is normal;

[0114] (2) Significant effect: The red blood cell count in urine sediment decreased by ≥40%;

[0115] (3) Effective: The red blood cell count in urine sediment decreased by <40%;

[0116] (4) Ineffective: No change or increase in red blood cell count in urine sediment.

[0117] The standards were formulated in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" in 2002.

[0118] 2. Evaluation of the efficacy of traditional Chinese medicine

[0119] (1) Cured: The clinical symptoms and signs of TCM disappear or basically disappear, and the symptom score decreases by ≥95%;

[0120] (2) Significant effect: The clinical symptoms and signs of TCM are significantly improved, and the symptom score is reduced by ≥70%;

[0121] (3) Effective: The clinical symptoms and signs of TCM patients have improved, and the symptom score has decreased by ≥30%;

[0122] (4) Ineffective: There is no significant improvement or even aggravation of clinical symptoms and signs in traditional Chinese medicine, and the symptom score decreases by <30%.

[0123] The standards were formulated in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" in 2002.

[0124] The calculation formula uses the nimodipine scoring method: {(pre-treatment score - post-treatment score) / pre-treatment score} × 100%.

[0125] 3. Safety evaluation

[0126] (1) Level 1: Safe, with no adverse reactions;

[0127] (2) Level 2: Relatively safe. If adverse reactions occur, no treatment is required and medication can continue.

[0128] (3) Level 3: There are safety issues and moderate adverse reactions. Medication can be continued after treatment.

[0129] (4) Level 4: The experiment was terminated due to adverse reactions.

[0130] The standards were formulated in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" in 2002.

[0131] 10. Statistical Analysis

[0132] This study used SPSS 26.0 for statistical data analysis. Clinical data such as disease course, TCM symptom scores, urinary red blood cell count, and serum creatinine were analyzed using the Shapiro-Wilk test to determine the normality of the measurement data. Measurement data conforming to a normal distribution were analyzed using... Data are expressed in M(P25, P75) form, and comparisons between two groups are performed using the independent samples t-test. Quantitative data that do not conform to a normal distribution are expressed in M(P25, P75) form, and comparisons between two groups are performed using the Wilcoxon rank-sum test. Count data, such as gender, are expressed in N(%) form, and comparisons are performed using the chi-square test or Fisher's precision test. A p-value < 0.05 is considered statistically significant.

[0133] XI. Research Results

[0134] (I) Analysis of General Situation Data

[0135] A total of 109 patients diagnosed with chronic nephritis syndrome by Western medicine and hematuria (syndrome of Qi and Yin deficiency with damp-heat stagnation) by Traditional Chinese Medicine (TCM) from October 1, 2021 to October 1, 2023, were screened from the outpatient and inpatient systems of Guangdong Provincial Hospital of Traditional Chinese Medicine. Among them, 10 patients had abnormal renal function (stage 2 or above of chronic kidney disease), 6 patients had 24-hour urinary protein quantification greater than 1g / d, 1 patient had a concurrent malignant tumor, and 19 patients had incomplete medical records (incomplete description of TCM symptoms or lack of laboratory records). Finally, 73 patients were included, divided into a ginseng and licorice root formula group (38 patients) and a control group (35 patients). The inclusion flowchart is shown below. Figure 2 As shown.

[0136] The ginseng and herbal root formula group consisted of 18 males and 20 females, with a mean age of 44 years; the control group consisted of 16 males and 19 females, with a mean age of 44 years. All these differences were statistically insignificant (P > 0.05), indicating comparability. The disease duration did not conform to a normal distribution, and non-parametric tests were used. The longest disease duration in the ginseng and herbal root formula group was 264 months, and in the control group it was 240 months. The shortest disease duration was 3 months in both groups, with a median difference of 1 month (P > 0.05), indicating no statistical significance and comparability between the two groups. The comparison results of age, gender, and disease duration between the two groups are shown in Tables 1-3.

[0137] 1. Comparison of ages between the two groups

[0138] Table 1 Age Analysis

[0139]

[0140] 2. Comparison of genders in the two groups

[0141] Table 2 Gender Analysis (N(%))

[0142]

[0143] 3. Comparison of disease duration (months) between the two groups

[0144] Table 3. Analysis of the disease course in the two groups [M(P)] 25 ,P 75 )]

[0145]

[0146] (II) Experimental Results

[0147] 1. Results of Traditional Chinese Medicine Efficacy Evaluation

[0148] (1) Comparison of TCM symptom scores between the two groups before treatment

[0149] Normality analysis showed that the two groups of data did not conform to a normal distribution. The Wilcoxon rank-sum test showed P = 0.820 > 0.05, indicating that the two groups were comparable. Table 4 shows the comparison of TCM symptom scores between the two groups before treatment.

[0150] Table 4. Analysis of symptom scores before treatment [M(P)] 25 P 75 )]

[0151]

[0152] (2) Comparison of TCM symptom scores before and after treatment in the two groups

[0153] The TCM symptom scores of the two groups of patients did not conform to a normal distribution, as determined by pre- and post-treatment comparisons and inter-group analyses. Therefore, non-parametric tests were used. Both groups showed P < 0.01 before and after treatment, indicating that the treatment effects in both groups were significantly effective. However, the inter-group comparison showed P = 0.018 < 0.05, indicating that the TCM treatment effect in the ginseng and licorice root formula group was better than that in the control group. The comparison results of TCM symptom scores before and after treatment in the two groups are shown in Table 5.

[0154] Table 5 Analysis of symptom scores before and after treatment [M(P)] 25 ,P 75 )]

[0155]

[0156]

[0157] (3) Comparison of the efficacy of TCM syndromes between the two groups

[0158] After two courses of treatment, using the Monidipine formula, one case in the Ginseng and Herbal Root Formula group was cured, with a total effective rate of 94.74%, while no cases were cured in the control group, with a total effective rate of 74.29%. Wilcoxon rank-sum test analysis showed Z = -3.169, P = 0.002 < 0.01, indicating a significant difference in the total effective rate between the two groups, demonstrating the significant efficacy of the Ginseng and Herbal Root Formula in improving TCM syndromes. The comparison results of the TCM syndrome efficacy between the two groups are shown in Table 6.

[0159] Table 6. Analysis of therapeutic efficacy after treatment

[0160]

[0161] (4) Comparison of TCM symptom scores before treatment between the two groups

[0162] Statistical analysis revealed that the individual symptom scores of the two groups before treatment did not conform to a normal distribution. Nonparametric tests showed that all scores had a p-value greater than 0.05, indicating no statistically significant difference and making them comparable. Table 7 shows the comparison of the individual symptom scores of the two groups before treatment.

[0163] Table 7 Analysis of TCM symptom scores before treatment in the two groups

[0164]

[0165]

[0166] (5) Comparison of TCM symptom scores before and after treatment in the two groups

[0167] The comparison before and after treatment within the group showed that, according to nonparametric test analysis, P < 0.01, indicating statistical significance. This suggests that both the ginseng and herbal root formula group and the control group were effective in improving TCM symptoms.

[0168] Intergroup comparison revealed that, except for no significant difference in improvement in pale complexion and rough skin, the statistical results for all other TCM symptoms were P < 0.05, indicating that the ginseng and licorice root formula group was more effective than the control group. Specifically, the statistical results for fixed or stabbing lower back pain, dry mouth, and sore throat were P = 0.003, P = 0.009, and P = 0.006, respectively, all < 0.01, indicating that the ginseng and licorice root formula group was significantly more effective than the control group in improving fixed or stabbing lower back pain, dry mouth, and sore throat. The comparison results of TCM symptom scores before and after treatment in both groups are shown in Table 8.

[0169] Table 8. Analysis of Traditional Chinese Medicine Symptom Scores Before and After Treatment

[0170]

[0171]

[0172] 2. Results of Western medicine efficacy assessment

[0173] (1) Comparison of red blood cell counts under microscopic examination before treatment between the two groups

[0174] Comparative analysis showed that the distribution did not conform to normality (P = 0.511 > 0.05), indicating no statistically significant difference and making them comparable. Table 9 shows the comparison of red blood cell counts under microscopic examination before treatment between the two groups.

[0175] Table 9 Analysis of erythrocyte count indicators under microscopic examination before treatment ( / HP) [M(P 25 ,P 75 )]

[0176]

[0177] (2) Comparison of urine red blood cell counts between the two groups before treatment

[0178] The normality test showed that the urinary red blood cell count did not follow a normal distribution (P = 0.533 > 0.05), indicating no statistical significance and thus comparability. Table 10 shows the comparison of urinary red blood cell counts between the two groups before treatment.

[0179] Table 10 Analysis of urinary red blood cell count indicators before treatment ( / μL) [M(P 25 ,P 75 )]

[0180]

[0181] (3) Comparison of red blood cell counts under microscopic examination before and after treatment in the two groups

[0182] The two groups of patients were compared by intragroup statistical tests. The results of the ginseng and licorice root formula group were P=0.000 and the results of the control group were P=0.000, both <0.01, indicating that there was a statistical difference and that both groups had significant therapeutic effects after treatment.

[0183] Nonparametric tests between groups showed that the difference in red blood cell counts under microscopic examination between the two groups after treatment was statistically significant (P = 0.044 < 0.05), indicating that the ginseng and licorice root formula group had a better therapeutic effect on improving red blood cell counts under microscopic examination than the control group. The results of the comparison of red blood cell counts under microscopic examination before and after treatment in both groups are shown in Table 11.

[0184] Table 11 Analysis of red blood cell counts ( / HP) before and after treatment in the two groups [M(P 25 P 75 )]

[0185]

[0186] (4) Comparison of urinary red blood cell counts before and after treatment in the two groups

[0187] Nonparametric tests showed statistically significant differences between the two groups before and after treatment, with P = 0.000 < 0.01, indicating that both groups had significant therapeutic effects after treatment.

[0188] Intergroup comparison showed a statistically significant difference in urinary red blood cell count between the two groups (P = 0.008 < 0.01), indicating that the ginseng and licorice root formula group was significantly better than the control group in reducing urinary red blood cell count. The results of the comparison of urinary red blood cell count before and after treatment in both groups are shown in Table 12.

[0189] Table 12 Analysis of urinary red blood cell counts before and after treatment in the two groups ( / μL) [M(P 25 ,P 75 )]

[0190]

[0191] (5) Comparison of efficacy between the two groups of Western medicine

[0192] In the ginseng and licorice root formula group, 2 cases were clinically controlled and 2 cases were ineffective, with an effective rate as high as 97.74%; in the control group, 1 case was clinically controlled and 5 cases were ineffective, with an effective rate of 85.71%. Statistical analysis showed a significant difference (Z = -3.615, P = 0.000 < 0.01), indicating that the efficacy of the ginseng and licorice root formula group was significantly better than that of the control group. The comparison results of the efficacy of the two groups are shown in Table 13.

[0193] Table 13 Efficacy analysis of Western medicine between the two groups

[0194]

[0195] 3. Safety evaluation

[0196] No significant adverse reactions were observed in either group during treatment. The Shapiro-Wilk test indicated that the relevant safety indicators did not conform to a normal distribution; therefore, non-parametric tests were used. Although there were statistically significant differences in ALT levels before and after treatment in both groups (P < 0.01) and in the control group (P < 0.05), ALT and AST did not double; in fact, they slightly decreased compared to pre-treatment levels. Other indicators showed no statistical significance (P > 0.05), indicating that both the ginseng and herbal root formula group and the control group were safe and reliable. The comparison results of safety indicators before and after treatment in the two groups are shown in Table 14.

[0197] Table 14 Analysis of safety indicators before and after treatment in the two groups [M(P)] 25 ,P 75 )]

[0198]

[0199]

[0200] 4. Conclusion

[0201] In summary, the ginseng and licorice root formula of this invention can not only reduce red blood cells in urine, but also improve clinical symptoms in traditional Chinese medicine such as soreness and weakness of the waist and knees, fixed or stabbing pain in the waist, pale complexion, fatigue, dry mouth, bitter taste in the mouth, sore throat, rough skin, and poor appetite. It has good therapeutic effect and reliable safety, and can significantly improve the treatment efficacy of chronic nephritis syndrome.

[0202] The above descriptions are merely some embodiments of the present invention. Those skilled in the art can make various modifications and improvements without departing from the inventive concept of the present invention, and these all fall within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating renal hematuria due to deficiency of both Qi and Yin, and damp-heat stagnation, characterized in that, It is made from the following raw materials in parts by weight: Codonopsis pilosula 5-15 parts, Rehmannia glutinosa 15-30 parts, Ligustrum lucidum 5-15 parts, Eclipta prostrata 5-15 parts, Imperata cylindrica 5-15 parts, Rubia cordifolia 5-15 parts, Cirsium japonicum 5-15 parts, Taraxacum mongolicum 5-15 parts, Prunus persica 5-8 parts, Glycyrrhiza uralensis 3-5 parts.

2. The traditional Chinese medicine composition for treating renal hematuria of the Qi and Yin deficiency and damp-heat stagnation syndrome according to claim 1, characterized in that, Pharmaceutically acceptable excipients can also be added.

3. The traditional Chinese medicine composition for treating renal hematuria of the Qi and Yin deficiency and damp-heat stagnation syndrome according to claim 1 or 2, characterized in that, The dosage form of the traditional Chinese medicine composition is decoction, granules, tablets, oral liquid, ointment, powder, pills or capsules.

4. The method for preparing the traditional Chinese medicine composition for treating renal hematuria of the Qi and Yin deficiency and damp-heat stagnation syndrome as described in any one of claims 1-3, characterized in that, When the dosage form of the traditional Chinese medicine composition is a decoction, its preparation method includes the following steps: Weigh the raw materials according to the formula, soak them in 4-8 times their weight of water for 15-30 minutes, then heat to boiling and keep simmering for 1-2 hours. Filter and collect the filtrate.

5. The use of the traditional Chinese medicine composition for treating renal hematuria of the Qi-Yin deficiency and damp-heat stagnation syndrome as described in any one of claims 1-3 in the preparation of a medicine for treating renal hematuria of the Qi-Yin deficiency and damp-heat stagnation syndrome.

6. The application according to claim 5, characterized in that, The renal hematuria mentioned refers to renal hematuria caused by chronic glomerulonephritis.

7. The use of the traditional Chinese medicine composition for treating renal hematuria of the Qi-Yin deficiency and damp-heat stagnation syndrome as described in any one of claims 1-3 in the preparation of a medicament for treating chronic nephritis syndrome of the Qi-Yin deficiency and damp-heat stagnation syndrome.

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