Traditional Chinese medicine composition for treating infantile anorexia and application thereof

Abstract

The invention relates to a traditional Chinese medicine composition for treating infantile anorexia. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 7-11 parts of radix pseudostellariae, 7-11 parts of rhizoma atractylodis, 7-11 parts of poria cocos, 7-11 parts of agastache rugosus, 7-11 parts of radix puerariae, 7-11 parts of pericarpium citri reticulatae viride, 6-13 parts of semen raphani, 4-8 parts of fructus forsythiae, 7-11 parts of rhizoma sparganii and 7-11 parts of hawthorn. The invention further provides application of the traditional Chinese medicine composition for treating infantile anorexia. The medicines are used together, spleen strengthening, spleen activating and spleen enlivening are integrated, spleen activating and spleen strengthening are achieved, spleen strengthening, qi tonifying, intestine and viscera dredging and descending are achieved simultaneously, qi movement of the spleen and the stomach is suitable for ascending and descending, then qi movement ascending and descending of the human body is regulated, qi movement of the whole body is achieved, qi circulation is achieved, five internal organs are harmonized, and the whole formula has the effects of strengthening the spleen and assisting in movement. The traditional Chinese medicine composition disclosed by the invention is superior to a control group in improvement conditions of total effective rate and traditional Chinese medicine syndrome points, and particularly has obvious advantages in improvement of main symptoms such as inappetence and food loss and symptoms such as salivation, belching and hiccup, nausea and the like in compulsory symptoms.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating anorexia in children and application thereof. Background Art

[0002] Anorexia is a digestive system disease in children characterized by long-term aversion to food and reduced food intake. Generally speaking, there are many main symptoms of anorexia in children, including vomiting, loss of appetite, constipation, abdominal pain, diarrhea, and blood in the stool.

[0003] Anorexia in children is a common pediatric disease. In traditional Chinese medicine, anorexia in children is divided into three types: spleen dysfunction, spleen and stomach qi deficiency, and spleen and stomach yin deficiency.

[0004] Chinese patent document CN110548109A discloses a Chinese medicine composition for treating anorexia in children and a preparation method thereof. The Chinese medicine composition is made of 12 raw materials of Codonopsis pilosula, Atractylodes macrocephala, Radix Ophiopogonis, Polygonatum odoratum, Dendrobium officinale, Crataegus pinnatifida, Paeonia lactiflora, Pericarpium Citri Reticulatae, Rhizoma Dioscoreae, Gallus gallifolia, Radix Glycyrrhizae, and Radix Glycyrrhizae through pretreatment, decoction, alcohol precipitation, concentration, drying, etc., and has the effects of invigorating qi and strengthening spleen, nourishing yin and nourishing stomach, and digesting food and removing stagnation. It is used for children with weak spleen and insufficient stomach yin, and for not wanting to eat or refusing to eat, with pale complexion, lack of energy, emaciation or puffiness, easy sweating, loose stool or constipation, or stagnation of diet, abdominal distension, etc. Animal experimental results show that the Chinese medicine composition of the present invention can increase the food intake of anorexia model rats, promote the secretion of gastrin in the gastric antrum, and can achieve the effect of treating both the symptoms and the root causes of anorexia in children, and has a broad market development prospect.

[0005] Chinese patent document CN106729584A discloses a Chinese medicine composition for treating anorexia in children and a preparation method thereof. The Chinese medicine composition for treating anorexia in children is refined with bupleurum, ginseng, ginger, evodia rutaecarpa, plantain seed, dendrobium, malt, hawthorn, wolfberry, atractylodes, atractylodes, chicken gizzard lining, patchouli, coptis root, oyster, radish seed, tsaoko, costusroot and nutmeg as raw materials. The Chinese medicine composition for treating anorexia in children is matched with multiple raw materials, scientifically formulated, reasonably compatible, and each raw material has complementary advantages, and utilizes the synergistic or resistant effects between them to improve the efficacy, and plays the effects of digestion, relieving stagnation, strengthening the spleen and replenishing qi, relieving depression and widening the middle, warming the middle and harmonizing qi, and can enhance the body's disease resistance, and the treatment of anorexia in children has a significant effect, is quick, non-irritating, has a low adverse reaction rate, and has a stable long-term efficacy, is safe and reliable, and can fundamentally improve the symptoms of anorexia.

[0006] There are many traditional Chinese medicine compositions for treating anorexia in children, but they all have more or less disadvantages, such as too many medicinal flavors, difficult to obtain materials, expensive prices, unclear efficacy, poor therapeutic effect, etc. Therefore, there is an urgent need for a traditional Chinese medicine composition for treating anorexia in children that has obvious efficacy, few medicinal flavors, is practical, highly compliant, safe and effective. Summary of the invention

[0007] The purpose of the present invention is to provide a Chinese medicine composition for treating anorexia in children and its application in view of the deficiencies in the prior art.

[0008] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating anorexia in children, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 7-11 parts of Pseudostellariae Radix, 7-11 parts of Atractylodes lancea, 7-11 parts of Poria cocos, 7-11 parts of Patchouli, 7-11 parts of Puerariae Radix, 7-11 parts of Citrus aurantium, 6-13 parts of Radish Seed, 4-8 parts of Forsythia suspensa, 7-11 parts of Trillium gracile, and 7-11 parts of Crataegus pinnatifida.

[0009] As a preferred example, the Chinese medicine composition is made of the following raw materials in parts by weight: 8-10 parts of Pseudostellariae Radix, 8-10 parts of Atractylodes lancea, 8-10 parts of Poria cocos, 8-10 parts of Patchouli, 8-10 parts of Puerariae Radix, 8-10 parts of Citrus aurantium, 7-11 parts of Radish Seed, 5-7 parts of Forsythia suspensa, 8-10 parts of Trillium, and 8-10 parts of Crataegus pinnatifida.

[0010] As another preferred example, the Chinese medicine composition is made of the following raw materials in parts by weight: 9 parts of Pseudostellariae Radix, 9 parts of Atractylodes lancea, 9 parts of Poria cocos, 9 parts of Patchouli, 9 parts of Puerariae Radix, 9 parts of Citrus aurantium, 9 parts of Radish Seed, 6 parts of Forsythia suspensa, 9 parts of Trillium, and 9 parts of Crataegus pinnatifida.

[0011] As another preferred example, the Chinese medicine composition is in the form of tablets, capsules, granules, oral liquids or syrups.

[0012] In a second aspect, the present invention provides use of a Chinese medicine composition in preparing a drug for treating anorexia in children.

[0013] As a preferred example, the anorexia in children is anorexia and spleen dysfunction syndrome.

[0014] The invention has the advantages that "the spleen is not invigorated but in transportation", and the treatment principle focuses on strengthening the spleen and promoting transportation, and regulating the rise and fall of qi. In the prescription, Radix Pseudostellariae and Atractylodes lancea are the monarchs, Radix Pseudostellariae is sweet, flat and slightly bitter, and can clear and nourish the spleen to strengthen the spleen. The spleen likes dryness and hates dampness, and its nature is good at transportation, and the spleen and stomach rise and fall are smooth to help the spleen transportation. Atractylodes lancea is good at drying dampness and strengthening the spleen, and it is in line with the nature of the spleen that likes dryness and hates dampness, and the aromatic gas of Atractylodes lancea is good at running around, entering the spleen and stomach meridians, and aromatic invigorates the spleen and strengthens transportation, and pleases the spleen and stimulates appetite. "Compendium of Materia Medica Chongyuan Atractylodes" says "If you want to move the spleen, use Atractylodes lancea", Radix Pseudostellariae and Atractylodes lancea are used together as the monarch, and aromatic invigorates the spleen, strengthens the spleen and promotes transportation. Patchouli and Poria cocos are the ministers, Poria cocos strengthens the spleen, Patchouli invigorates the spleen, and is a key medicine for treating spleen and stomach disharmony, and is good at invigorating the spleen and removing dampness and promoting transportation, and can help Atractylodes lancea to dry dampness and strengthen the spleen, and aromatic invigorates the spleen. In the formula, kudzu root, green peel, hawthorn, radish seed, trillium and forsythia are all adjuvants. Kudzu root raises yang and invigorates stomach qi, green peel promotes qi and eliminates accumulation, hawthorn stimulates appetite and helps digestion, and combined with Pseudostellaria baicalensis, which invigorates qi, both eliminates and supplements, so that supplementation does not stagnate; if the spleen is not healthy, it is easy to hinder the qi and food accumulation to generate heat, trillium clears the intestinal stagnation, clears and descends the visceral qi, stir-fried radish seed helps digestion and eliminates accumulation, moistens and clears the intestines and viscera, and assists Atractylodes in raising and lowering the spleen and stomach qi; forsythia tastes bitter and slightly cold, which can not only clear the heat generated by food accumulation, but also disperse the knot to help eliminate accumulation. All the medicines are used together to strengthen the spleen, transport the spleen, and wake up the spleen, so that the spleen can be healthy. In the formula, strengthening the spleen and invigorating qi and clearing and descending the intestines and viscera are used at the same time, and the spleen and stomach qi rise and fall appropriately, thereby regulating the rise and fall of the human body's qi, so that the whole body's qi can be transported, the qi can be transformed, and the five internal organs are in harmony, and the whole formula plays the effect of strengthening the spleen and promoting transportation. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 : PASS running result. DETAILED DESCRIPTION

[0016] The present invention will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and are not intended to limit the scope of the present invention. In addition, it should be understood that after reading the content of the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms fall within the scope limited by the appended claims of the application equally.

[0017] Example 1 A Chinese medicine composition for treating anorexia in children (I)

[0018] 9 parts of Pseudostellariae Radix, 9 parts of Atractylodes lancea, 9 parts of Poria, 9 parts of Patchouli, 9 parts of Puerariae Radix, 9 parts of Citrus aurantium, 9 parts of Radish Seed, 6 parts of Forsythiae, 9 parts of Trigonosciadium japonicum, and 9 parts of Crataegus pinnatifida.

[0019] Example 2 A Chinese medicine composition for treating anorexia in children (II)

[0020] 9 parts of Pseudostellariae Radix, 7 parts of Atractylodes lancea, 11 parts of Poria, 8 parts of Patchouli, 10 parts of Puerariae Radix, 9 parts of Citrus aurantium, 6 parts of Radish Seed, 8 parts of Forsythia suspensa, 8 parts of Tripterygium wilfordii, and 10 parts of Crataegus pinnatifida.

[0021] Example 3 A Chinese medicine composition for treating anorexia in children (III)

[0022] 7 parts of Pseudostellariae Radix, 11 parts of Atractylodes lancea, 8 parts of Poria, 10 parts of Patchouli, 9 parts of Puerariae Radix, 7 parts of Citrus aurantium, 13 parts of Radish Seeds, 5 parts of Forsythiae, 10 parts of Tripterygium wilfordii, and 9 parts of Crataegus pinnatifida.

[0023] Example 4 A Chinese medicine composition for treating anorexia in children (IV)

[0024] 11 parts of Pseudostellariae Radix, 8 parts of Atractylodes lancea, 10 parts of Poria, 9 parts of Patchouli, 7 parts of Puerariae Radix, 11 parts of Citrus aurantium, 7 parts of Radish Seed, 7 parts of Forsythiae Fructus, 9 parts of Tripterygium wilfordii, and 7 parts of Crataegus pinnatifida.

[0025] Example 5 A Chinese medicine composition for treating anorexia in children (V)

[0026] 8 parts of Pseudostellariae Radix, 10 parts of Atractylodes lancea, 9 parts of Poria, 7 parts of Patchouli, 11 parts of Puerariae Radix, 8 parts of Citrus aurantium, 11 parts of Radish Seeds, 6 parts of Forsythiae, 7 parts of Tripterygium wilfordii, and 11 parts of Crataegus pinnatifida.

[0027] Example 6 A Chinese medicine composition for treating anorexia in children (VI)

[0028] 10 parts of Pseudostellariae Radix, 9 parts of Atractylodes lancea, 7 parts of Poria, 11 parts of Patchouli, 8 parts of Puerariae Radix, 10 parts of Citrus aurantium, 9 parts of Radish Seed, 4 parts of Forsythiae, 11 parts of Tripterygium wilfordii, and 8 parts of Crataegus pinnatifida.

[0029] Example 7 A Chinese medicine composition for treating anorexia in children (VII)

[0030] 9 parts of Pseudostellariae Radix, 11 parts of Atractylodes lancea, 8 parts of Poria, 10 parts of Patchouli, 9 parts of Puerariae Radix, 7 parts of Citrus aurantium, 13 parts of Radish Seeds, 5 parts of Forsythiae, 10 parts of Tripterygium wilfordii, and 9 parts of Crataegus pinnatifida.

[0031] Example 8 A Chinese medicine composition for treating anorexia in children (VIII)

[0032] 7 parts of Pseudostellariae Radix, 8 parts of Atractylodes lancea, 10 parts of Poria, 9 parts of Patchouli, 7 parts of Puerariae Radix, 11 parts of Citrus aurantium, 7 parts of Radish Seed, 7 parts of Forsythia suspensa, 9 parts of Tripterygium wilfordii, and 7 parts of Crataegus pinnatifida.

[0033] Example 9 A Chinese medicine composition for treating anorexia in children (IX)

[0034] 11 parts of Pseudostellariae Radix, 10 parts of Atractylodes Rhizome, 9 parts of Poria, 7 parts of Patchouli, 11 parts of Puerariae Radix, 8 parts of Citrus Aurantii, 11 parts of Radish Seed, 6 parts of Forsythiae Fructus, 7 parts of Tripterygium Wrightii, and 11 parts of Crataegus Pinnatifida.

[0035] Example 10 A Chinese medicine composition for treating anorexia in children (X)

[0036] 8 parts of Pseudostellariae Radix, 9 parts of Atractylodes lancea, 7 parts of Poria, 11 parts of Patchouli, 8 parts of Puerariae Radix, 10 parts of Citrus aurantium, 9 parts of Radish Seed, 4 parts of Forsythiae, 11 parts of Tripterygium wilfordii, and 8 parts of Crataegus pinnatifida.

[0037] Example 11 A Chinese medicinal composition for treating anorexia in children (XI)

[0038] 10 parts of Pseudostellariae Radix, 7 parts of Atractylodes lancea, 11 parts of Poria, 8 parts of Patchouli, 10 parts of Puerariae Radix, 9 parts of Citrus aurantium, 6 parts of Radish Seed, 8 parts of Forsythia suspensa, 8 parts of Tripterygium wilfordii, and 10 parts of Crataegus pinnatifida.

[0039] Example 12: Method of using a Chinese medicine composition for treating anorexia in children

[0040] Usage: Take any one of the Chinese medicine compositions of Examples 1-11; dissolve it in boiling water and take it, a total of 200 ml, twice a day, morning and evening.

[0041] This Chinese medicine formula is mainly used for anorexia in children, with symptoms of loss of appetite, aversion to food or even refusal to eat. Pale complexion, good spirits, bland taste in the mouth, occasional drooling, belching, hiccups, nausea, loose stools, etc. Tongue, pulse and fingerprints: pale red tongue, thin white or greasy fur, moist pulse, pale red fingerprints.

[0042] Example 13 Clinical Trial

[0043] 1.1 Research subjects

[0044] The cases in this trial were derived from children who visited the pediatric outpatient clinic of the Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine from March 2023 to December 2023. The children who met the inclusion criteria were divided into a treatment group and a control group using the random number method. The legal guardians and children were fully informed before enrollment and signed an informed consent form at the same time.

[0045] 1.2 Sample size calculation

[0046] According to the literature, previous studies have shown that the efficacy of traditional Chinese medicine treatment is 95%, and the efficacy of Xingpi Yanger Granule is 77.5%. Using a two-sided test, setting α = 0.05, and the power of 80%, the PASS2021 software was used to calculate N (treatment group) = 71 cases, N (control group) = 71 cases (see Figure 1 ). Assuming that the loss-to-follow-up rate of the subjects is 10%, the required sample size is N (treatment group) = 71 ÷ 0.9 = 79 cases, and N (control group) = 71 ÷ 0.9 = 79 cases. Finally, 79 subjects were included in the treatment group and 79 subjects were included in the control group, with a total of at least 158 ​​subjects included.

[0047] 1.3 Western medicine diagnostic criteria

[0048] Refer to Zhu Futang's Practical Pediatrics (9th Edition):

[0049] (1) Age: Children under 14 years old.

[0050] (2) The child's appetite is significantly reduced, and the child has no desire to eat or even refuses to eat. The amount of food consumed is significantly less than in the past. Children under 3 years old consume less than 50g of cereals such as pasta, rice, and bread per day, and children over 3 years old consume less than 75g of cereals per day. At the same time, the intake of meat, eggs, and milk is very small.

[0051] (3) Dietary survey: The protein energy intake was insufficient, only 70% of the standard supply; the mineral and vitamin intake was insufficient, only 5% of the standard supply.

[0052] (4) Growth and development: Excluding genetic factors, the height and weight of children are lower than the normal average level for the same age. There is no significant increase in height and weight during the anorexia period.

[0053] 1.4 TCM diagnostic criteria

[0054] Refer to the 2012 Chinese Association of Traditional Chinese Medicine's "Guidelines for Diagnosis and Treatment of Common Pediatric Diseases in Traditional Chinese Medicine" for the syndrome standard of anorexia and spleen dysfunction in children:

[0055] Main symptoms: Children have loss of appetite, aversion to food or even refusal to eat.

[0056] Concomitant symptoms: Pale complexion, fair spirit, bland taste in the mouth, occasional drooling, belching, hiccups, nausea, loose stools, tongue, pulse, and fingerprints: pale red tongue with a thin white or greasy coating, moist pulse, and pale red fingerprints.

[0057] Contains 4 main symptoms + concurrent symptoms, and refers to tongue, pulse, and fingerprints.

[0058] 1.5 Inclusion criteria

[0059] (1) The child meets the criteria for anorexia.

[0060] (2) According to TCM diagnosis, this disease is characterized by spleen dysfunction.

[0061] (3) Children aged 1 to 12 years old and able to cooperate with the treatment.

[0062] (4) Children with a disease course of more than 4 weeks.

[0063] (5) The informed consent process complies with regulations and the legal representative signs the informed consent form.

[0064] 1.6 Exclusion criteria

[0065] (1) Anorexia caused by diseases, such as acute and chronic gastroenteritis, peptic ulcer, respiratory tract infection, acute and chronic hepatitis, anorexia nervosa and anorexia caused by certain drugs.

[0066] (2) Children with moderate and severe malnutrition are classified as having malnutrition in traditional Chinese medicine.

[0067] (3) Combined with serious primary diseases of the heart, liver, kidney, digestive system and hematopoietic system.

[0068] (4) Allergy to the experimental drug or its ingredients.

[0069] (5) Other diseases or conditions that, according to the investigator's judgment, reduce the likelihood of enrollment or complicate enrollment, such as unstable living environment, inconvenient transportation, etc., which may easily lead to loss to follow-up.

[0070] 1.7 Shedding Standard

[0071] 1.7.1 Researcher Decision to Withdraw

[0072] (1) Allergic reactions or serious adverse events occur, and the trial should be stopped according to the doctor's judgment.

[0073] (2) During the trial, the patient suffers from other diseases that affect the judgment of efficacy and safety.

[0074] (3) The children have poor compliance (compliance with the trial medication is less than 80%, or greater than 120%), or they automatically change medications midway or add Chinese or Western medicines that are prohibited by this protocol.

[0075] 1.7.2 The test child withdraws on his / her own initiative.

[0076] (1) For whatever reason, the patient or his / her legal guardian is unwilling or unable to continue the clinical trial and requests the attending physician to withdraw from the trial, thereby terminating the trial.

[0077] (2) Children who did not explicitly request to withdraw from the trial but no longer received medication or testing and were lost to follow-up.

[0078] 1.8 Elimination criteria

[0079] (1) After randomization, patients are found to have seriously violated the inclusion or exclusion criteria.

[0080] (2) Those who have not taken any medication after randomization or have no post-treatment visit records.

[0081] (3)Others.

[0082] 1.9 Suspension of Clinical Trials

[0083] If a serious safety incident occurs during the trial, the trial should be terminated promptly. If a major error is found in the clinical trial protocol, or a good protocol occurs but serious deviations occur during implementation, making it difficult to evaluate the efficacy of the drug, the trial should be terminated. If a drug treatment effect is poor and has no clinical value, the trial should be terminated.

[0084] 2. Research Methods

[0085] 2.1 Grouping method

[0086] A total of 158 children with anorexia were collected from the pediatric outpatient department of the Shanghai Traditional Chinese Medicine Hospital affiliated to Shanghai University of Traditional Chinese Medicine. The case numbers were set as 1 according to the order of consultation. ～ 158. SPSS25.0 software was used to generate a random number table, and the random numbers were grouped from small to large, and then divided into the treatment group and the control group according to the sequence numbers from low to high.

[0087] 2.2 Treatment methods

[0088] Treatment group: 9 parts of Pseudostellariae Radix, 9 parts of Atractylodes lancea, 9 parts of Poria cocos, 9 parts of Patchouli, 9 parts of Puerariae Radix, 9 parts of Citrus aurantium, 9 parts of Radish Seed, 6 parts of Forsythiae Fructus, 9 parts of Trigonosciadium japonicum, 9 parts of Crataegus pinnatifida; take with boiling water, a total of 200 ml, twice a day, morning and evening. For children over 3 years old, use the middle amount of the prescription, and for children aged 1-2 years old, use 1 / 2 of the prescription.

[0089] Control group: Xingpi Yanger Granule

[0090] Dosage and Administration: For children aged 1-2 years old, take 2 bags at a time, twice a day; for children aged 3-6 years old, take 2 bags at a time, three times a day; for children aged 7-12 years old, take 3-4 bags at a time, twice a day.

[0091] In this study, one course of treatment was 2 weeks, and medication was given for 2 courses.

[0092] The above-mentioned Chinese medicines were purchased from the Granule Pharmacy of the Pharmacy Department of Shanghai Traditional Chinese Medicine Hospital and produced by Sichuan Xinlu Pharmaceutical Co., Ltd.

[0093] The Xingpi Yanger Granules (Guizhou Jianxing Pharmaceutical Co., Ltd., approval number: National Medicine Standard Z20025415) used in this study mainly contain: red stigma, gerbera hairy, gardenia tea, and spider incense.

[0094] 2.3 Observation indicators

[0095] 2.3.1 General

[0096] Record the child's age, gender, course of disease, height, weight, etc.;

[0097] 2.3.2 Main efficacy indicators

[0098] The changes in the children's appetite and food intake were recorded before treatment and 4 weeks after treatment;

[0099] 2.3.3 Secondary reference indicators

[0100] The children's complexion, spirit, tasteless mouth, salivation, belching, hiccups, nausea, loose stools, etc. were observed before treatment and 4 weeks after treatment (TCM Clinical Symptom Scoring Scale (Appendix 1)), and the Children's Eating Behavior Scale (Appendix 2) was scored.

[0101] 2.3.4 Adverse reactions in the treatment groups

[0102] Observe and record whether the children have any adverse reactions during the use of the Chinese medicine prescription.

[0103] 2.4 Efficacy evaluation

[0104] The efficacy evaluation criteria are formulated with reference to the "Guidelines for Clinical Research of New Chinese Medicines (Trial)" as follows:

[0105] Clinical recovery: TCM clinical symptoms and signs have disappeared or basically disappeared, and the syndrome score has decreased by ≥95%;

[0106] Markedly effective: Most of the clinical symptoms and signs of TCM disappear, and the syndrome score decreases by ≥70% but <95%;

[0107] Effective: TCM clinical symptoms and signs have improved, and the syndrome score has decreased by ≥30% but <70%;

[0108] Ineffective: There is no significant improvement in TCM clinical symptoms and signs, or they may even get worse, and the syndrome score is reduced by less than 30%.

[0109] Note: The sum of TCM symptom scores = loss of appetite + decreased food intake + mental state + pale complexion + bland taste in the mouth + drooling + belching and hiccups + nausea + loose stools; Symptom score reduction rate = [(sum of symptom scores before treatment - sum of symptom scores after treatment) / sum of symptom scores before treatment] × 100%.

[0110] 3. Data entry and statistical methods

[0111] The data of this trial should be recorded in the corresponding CRF form in a standardized manner during collection. The CRF form is filled in by the clinical researcher and the data is entered using Excel 2019 software.

[0112] The data in this experiment were statistically processed using SPSS26.0 software, using a two-sided test with a test level of α = 0.05, and P < 0.05 was considered statistically significant. The data were expressed as normal distribution and homogeneity of variance, and the t test was used. The Mann-Whitney U test for two independent samples and the Wilcoxon test for two related samples were used for comparison of rank data, and the χ2 test or Fisher's exact probability method was used for multiple rates or multiple component ratios. At the two-sided test level, P < 0.05 was considered statistically significant.

[0113] 4. Results

[0114] 4.1 General Data Comparison

[0115] A total of 158 children were included in this study and randomly divided into a control group and a treatment group of 79 children each. During the study, 9 cases dropped out, including 5 in the control group, 3 of which were complicated by bronchial pneumonia and 2 of which were parents' failure to cooperate in the later stage; 4 children dropped out in the treatment group, 3 of which were complicated by acute respiratory tract infection and 1 of which was parents' failure to cooperate in the later stage. A total of 149 children finally completed the experiment.

[0116] 4.1.1 Comparison of gender between the two groups

[0117] Table 1-1 Gender distribution

[0118]

[0119]

[0120] The chi-square test showed that the gender of the children in the treatment group and the control group was no different, χ2=0.114, P>0.05. The statistical results showed that there was no difference in gender distribution between the two groups and they were comparable.

[0121] 4.1.2 Comparison of the ages of the two groups of patients

[0122] Table 1-2 Comparison of ages between the two groups

[0123]

[0124] The ages of the children in the treatment group and the control group did not conform to the normal distribution after normal test. The rank sum test was used, P>0.05. The statistical results showed that there was no difference in age distribution between the two groups and they were comparable.

[0125] 4.1.3 Comparison of body weight between the two groups

[0126] Table 1-3 Comparison of body mass before treatment between the two groups of children

[0127]

[0128] The body weight of children in the treatment group and the control group conformed to the normal distribution and had homogeneity of variance. Two independent sample t-tests were used, and P=0.629>0.05. The statistical results showed that there was no difference in body weight distribution between the two groups and they were comparable.

[0129] 4.2 Comparison of clinical syndrome scores before treatment

[0130] 4.2.1 Comparison of main symptom scores before treatment

[0131] Table 1-3 Comparison of main symptom scores between the two groups of children before treatment

[0132]

[0133] The data did not meet the normal distribution, so a rank sum test was performed to compare the main symptom scores between the two groups. P was greater than 0.05. The statistical results showed that there was no difference in the main symptom scores between the two groups and they were comparable.

[0134] 4.2.2 Comparison of symptom scores of various complications before treatment

[0135] Table 1-4 Comparison of main symptom scores between the two groups of children before treatment

[0136]

[0137] The data did not meet the normal distribution, so a rank sum test was performed to compare the symptom scores of various complications between the two groups. P was greater than 0.05. The statistical results showed that there was no difference in the symptom scores of various complications between the two groups, and the two groups were comparable.

[0138] 4.2.3 Comparison of total clinical syndrome scores before treatment

[0139] Table 1-5 Comparison of clinical syndrome scores between the two groups of children before treatment

[0140]

[0141] The data did not meet the normal distribution, and the rank sum test was performed to compare the total scores of main symptoms, total scores of concomitant symptoms, and TCM syndrome scores between the two groups. P was greater than 0.05. The statistical results showed that there was no difference in the total scores of main symptoms, total scores of concomitant symptoms, and TCM syndrome scores between the two groups, and the two groups were comparable.

[0142] 4.3 Comparison of clinical syndrome scores before and after treatment

[0143] 4.3.1 Comparison of main symptom scores before and after treatment

[0144] Table 1-6 Comparison of the main symptom scores of the two groups of children before and after treatment

[0145]

[0146] The data did not meet the normal distribution, so the rank sum test was used. The results showed that the main symptom scores of the control group and the treatment group were significantly reduced (all P < 0.001), indicating that the main symptoms of the two groups of children were significantly improved compared with before treatment.

[0147] 4.3.2 Comparison of symptom scores before and after treatment

[0148] Table 1-7 Comparison of the symptom scores of the two groups of children before and after treatment

[0149]

[0150] The data did not meet the normal distribution, so the rank sum test was used. The results showed that the symptom scores of various concomitant symptoms in the control group and the treatment group were significantly reduced (all P < 0.001), indicating that after treatment, the concomitant symptoms of the two groups of children were significantly improved compared with those before treatment.

[0151] 4.3.3 Comparison of clinical syndrome scores before and after treatment

[0152] Table 1-8 Comparison of clinical syndrome scores between the two groups of children before and after treatment

[0153]

[0154] The data did not meet the normal distribution, so the rank sum test was used. The results showed that the total scores of main symptoms, total scores of concomitant symptoms, and TCM syndrome scores were significantly reduced between the two groups (all P < 0.001), indicating that after treatment, the total scores of main symptoms, total scores of concomitant symptoms, and TCM syndrome scores of the two groups of children were significantly improved compared with those before treatment.

[0155] 4.4 Comparison of clinical syndrome scores after treatment

[0156] 4.4.1 Comparison of main symptom scores after treatment

[0157] Table 1-9 Comparison of main symptom scores between the two groups of children after treatment

[0158]

[0159]

[0160] The data did not meet the normal distribution, and the rank sum test was performed to compare the main symptom scores between the two groups. P was <0.05. The statistical results showed that there were statistical differences in the improvement of the main symptom scores between the two groups. After treatment, the treatment group was better than the control group in the improvement of the main symptoms (appetite and food intake).

[0161] 4.4.2 Comparison of symptom scores of various complications after treatment

[0162] Table 1-10 Comparison of main symptom scores between the two groups of children after treatment

[0163]

[0164] The data did not meet the normal distribution, so the rank sum test was performed to compare the scores of the symptom of each concomitant disease between the two groups after treatment. After treatment, the comparison between the treatment group and the control group showed that the treatment group was better than the control group in terms of the improvement of the scores of concomitant symptoms such as drooling, belching, hiccups, and nausea (all P < 0.05). There was no statistically significant difference between the two groups in terms of the improvement of the scores of concomitant symptoms such as mental state, complexion, bland taste in the mouth, and loose stools (all P > 0.05).

[0165] 4.4.3 Comparison of total clinical symptom scores after treatment

[0166] Table 1-11 Comparison of clinical syndrome scores between the two groups of children after treatment

[0167]

[0168] The data did not meet the normal distribution, so the rank sum test was performed. After treatment, the total score of the main symptoms, the total score of the concomitant symptoms and the total score of the syndrome in the treatment group were significantly better than those in the control group (all P < 0.05).

[0169] 4.5 Comparison of dietary behaviors between the two groups

[0170] 4.5.1 Comparison of eating behaviors between the two groups before treatment

[0171] Table 1-11 Comparison of dietary behavior between the two groups of children before treatment

[0172]

[0173]

[0174] The data did not meet the normal distribution, and the rank sum test was performed to compare the eating behaviors such as oversatiety response and slow eating between the two groups. P>0.05. The statistical results showed that there was no difference in the eating behavior scale scores between the two groups, and they were comparable.

[0175] 4.5.1 Comparison of eating behaviors between the two groups before and after treatment

[0176] Table 1-11 Comparison of dietary behavior between the two groups of children before and after treatment

[0177]

[0178]

[0179] The data did not meet the normal distribution, and the rank sum test was used. The results showed that the scores of oversatiety response, slow eating, food response, and food preference in the two groups were significantly reduced (all P < 0.001), indicating that after treatment, the oversatiety response, slow eating, food response, and food preference of the two groups of children were significantly improved compared with before treatment; the scores of picky eating and emotional eating in the two groups were reduced (P < 0.05), indicating that after treatment, the picky eating and emotional eating of the two groups of children were improved compared with before treatment; in the score of craving for beverages before and after treatment, the control group P = 0.151, the treatment group P = 0.351, (P > 0.05), indicating that there was no statistical difference in the craving for beverages before and after treatment.

[0180] 4.6 Comparison of the effective rate of TCM syndromes between the two groups of children

[0181] Table 1-12 Comparison of the total effective rate of TCM syndromes in the two groups of children after treatment

[0182]

[0183] After treatment, the total effective rate of the control group was 83.78%, including 6 cases of recovery, 14 cases of marked effect, 42 cases of effectiveness, and 12 cases of ineffectiveness; the total effective rate of the treatment group was 96.00%, including 18 cases of recovery, 32 cases of marked effect, 22 cases of effectiveness, and 3 cases of ineffectiveness. The difference in the total effective rate between the two groups of children was statistically significant (P < 0.05), see table.

[0184] 4.7 Security Comparison

[0185] During the treatment, no adverse reactions such as allergic and gastrointestinal reactions occurred in the two groups of children.

[0186] 5 Conclusion

[0187] The results of this study showed that the Chinese medicine formula was superior to the control group in terms of total effective rate and improvement of TCM syndrome score, especially in improving main symptoms such as loss of appetite and decreased food intake, as well as concomitant symptoms such as drooling, belching, hiccups, and nausea.

[0188] The above is only a preferred embodiment of the present invention. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the method of the present invention. These improvements and supplements should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating anorexia in children, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 7-11 parts of Pseudostellariae Radix, 7-11 parts of Atractylodes lancea, 7-11 parts of Poria cocos, 7-11 parts of Patchouli, 7-11 parts of Puerariae Radix, 7-11 parts of Citrus aurantium, 6-13 parts of Radish Seed, 4-8 parts of Forsythia suspensa, 7-11 parts of Tripterygium wilfordii, and 7-11 parts of Crataegus pinnatifida.

2. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 8-10 parts of Pseudostellariae Radix, 8-10 parts of Atractylodes lancea, 8-10 parts of Poria cocos, 8-10 parts of Patchouli, 8-10 parts of Puerariae Radix, 8-10 parts of Citrus aurantium, 7-11 parts of Radish Seed, 5-7 parts of Forsythia suspensa, 8-10 parts of Trillium gracile and 8-10 parts of Crataegus pinnatifida.

3. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition is prepared from the following raw materials in parts by weight: 9 parts of Pseudostellariae Radix, 9 parts of Atractylodes lancea, 9 parts of Poria cocos, 9 parts of Patchouli, 9 parts of Puerariae Radix, 9 parts of Citrus aurantium, 9 parts of Radish Seed, 6 parts of Forsythia suspensa, 9 parts of Tripterygium wilfordii and 9 parts of Crataegus pinnatifida.

4. The Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The medicine of the Chinese medicine composition is tablet, capsule, granule, oral liquid or syrup.

5. Use of the Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a drug for treating anorexia in children.

6. The use according to claim 5, characterized in that: The described anorexia in children is a syndrome of anorexia and spleen dysfunction in children.

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