A traditional Chinese medicine composition for treating anorexia in children and application thereof

Abstract

The present application relates to a kind of traditional Chinese medicine composition for treating pediatric anorexia, the traditional Chinese medicine composition is made of the following weight parts of raw medicinal materials: 7-11 parts of Taizishen, 7-11 parts of Cangzhu, 7-11 parts of Fuling, 7-11 parts of Huoxiang, 7-11 parts of Gegen, 7-11 parts of Qingpi, 6-13 parts of Laiqiezi, 4-8 parts of Lianqiao, 7-11 parts of Sanleng, 7-11 parts of Shanzha.The present application also provides the use of traditional Chinese medicine composition for pediatric anorexia.The present application uses several drugs together, which is integrated with invigorating spleen, transporting spleen and activating spleen, so that the spleen is healthy, the spleen and stomach qi movement is appropriate, and the human body qi movement is adjusted, so that the whole body qi movement is operated, the qi movement is operated, the five internal organs are harmonious, and the whole prescription plays the effect of invigorating spleen and transporting.The total effective rate and the improvement of TCM syndrome score of the traditional Chinese medicine composition of the present application are better than those of the control group, especially in improving the symptoms of anorexia, reduced food intake and other symptoms such as salivation, belching, hiccups, nausea and other symptoms.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating infantile anorexia and application thereof. BACKGROUND

[0002] Infantile anorexia is a kind of children's digestive system disease with long-term aversion to food and reduced food intake as the main symptom. Generally speaking, the main symptoms of infantile anorexia include vomiting, loss of appetite or anorexia, constipation, abdominal pain, diarrhea and hematochezia.

[0003] Infantile anorexia is a common pediatric disease, which is divided into three types of syndromes, namely, spleen dysfunction, spleen and stomach qi deficiency, and spleen and stomach yin deficiency.

[0004] Chinese patent document CN110548109A discloses a traditional Chinese medicine composition for treating infantile anorexia and a preparation method thereof. The traditional Chinese medicine composition is prepared from 12 kinds of raw medicinal materials, including radix ginseng, rhizoma atractylodis macrocephalae, radix ophiopogonis, dendrobium, hawthorn, radix paeoniae alba, pericarpium citri reticulatae, radix paeoniae alba, radix paeoniae alba, chicken gizzard, radix ophiopogonis, and radix glycyrrhizae, through pretreatment, decoction, alcohol precipitation, concentration, and drying processes. The traditional Chinese medicine composition has the effects of tonifying qi and invigorating the spleen, nourishing yin and nourishing the stomach, and promoting digestion and reducing stagnation. It is used for treating infantile anorexia caused by spleen qi deficiency, stomach yin deficiency, loss of appetite or refusal to eat, pale complexion, lack of spirit, emaciation or emaciation, easy sweating, loose stool or constipation, food stagnation, and abdominal distension. Animal experiment results show that the traditional Chinese medicine composition can increase the food intake of anorexia model rats and promote the secretion of antral gastrin. It can achieve the effect of treating the symptoms and the root cause of infantile anorexia and has a broad market development prospect.

[0005] Chinese patent document CN106729584A discloses a traditional Chinese medicine composition for treating infantile anorexia and a preparation method thereof. The traditional Chinese medicine composition for treating infantile anorexia is refined from raw materials including radix bupleuri, radix ginseng, processed ginger, evodia, semen plantaginis, dendrobium, malt, hawthorn, medlar, rhizoma atractylodis, rhizoma atractylodis macrocephalae, chicken gizzard, agastache, rhizoma coptidis, ostrea, semen raphani, fructus amomi, and myristica. The traditional Chinese medicine composition for treating infantile anorexia is prepared by combining multiple raw materials, scientifically formulating, and reasonably matching. The advantages of each raw material are complementary, and the synergistic or antagonistic effects among the raw materials are utilized to improve the efficacy. The traditional Chinese medicine composition has the effects of promoting digestion and reducing stagnation, invigorating the spleen and tonifying qi, relieving depression and regulating the middle, and warming the middle and qi. It can enhance the body's resistance to disease, has a significant effect on treating infantile anorexia, works quickly, has no irritation, has a low adverse reaction rate, has a stable long-term effect, is safe and reliable, and can fundamentally improve the symptoms of anorexia.

[0006] There are many traditional Chinese medicine compositions for treating infantile anorexia, but all have more or less shortcomings, for example, too many flavors, difficult to obtain materials, high price, poor efficacy, poor treatment effect, etc. Therefore, there is an urgent need for a traditional Chinese medicine composition for treating infantile anorexia with obvious effect, fewer flavors, practicality, high compliance and safety and effectiveness. SUMMARY

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

[0008] In a first aspect, the present application provides a traditional Chinese medicine composition for treating infantile anorexia, which is made of the following raw medicinal materials by weight: 7-11 parts of Taizishen, 7-11 parts of Cangzhu, 7-11 parts of Fuling, 7-11 parts of Huoxiang, 7-11 parts of Gegen, 7-11 parts of Qingpi, 6-13 parts of Laihuangzi, 4-8 parts of Lianqiao, 7-11 parts of Sanleng, and 7-11 parts of Shanzha.

[0009] As a preferred example, the traditional Chinese medicine composition is made of the following raw medicinal materials by weight: 8-10 parts of Taizishen, 8-10 parts of Cangzhu, 8-10 parts of Fuling, 8-10 parts of Huoxiang, 8-10 parts of Gegen, 8-10 parts of Qingpi, 7-11 parts of Laihuangzi, 5-7 parts of Lianqiao, 8-10 parts of Sanleng, and 8-10 parts of Shanzha.

[0010] As another preferred example, the traditional Chinese medicine composition is made of the following raw medicinal materials by weight: 9 parts of Taizishen, 9 parts of Cangzhu, 9 parts of Fuling, 9 parts of Huoxiang, 9 parts of Gegen, 9 parts of Qingpi, 9 parts of Laihuangzi, 6 parts of Lianqiao, 9 parts of Sanleng, and 9 parts of Shanzha.

[0011] As another preferred example, the traditional Chinese medicine composition is made of the following raw medicinal materials by weight: 9 parts of Taizishen, 9 parts of Cangzhu, 9 parts of Fuling, 9 parts of Huoxiang, 9 parts of Gegen, 9 parts of Qingpi, 9 parts of Laihuangzi, 6 parts of Lianqiao, 9 parts of Sanleng, and 9 parts of Shanzha.

[0012] As another preferred example, the traditional Chinese medicine composition is made of the following raw medicinal materials by weight: 9 parts of Taizishen, 9 parts of Cangzhu, 9 parts of Fuling, 9 parts of Huoxiang, 9 parts of Gegen, 9 parts of Qingpi, 9 parts of Laihuangzi, 6 parts of Lianqiao, 9 parts of Sanleng, and 9 parts of Shanzha.

[0013] As a preferred example, the infantile anorexia is a child anorexia with spleen dysfunction.

[0014] The present application has the advantages that: "Spleen is not in the supplement is in the operation", the treatment principle focuses on strengthening the spleen and assisting the transportation, and adjusting the Qi movement. In the prescription, Taizishen and Cangzhu are the monarch, Taizishen is sweet and slightly bitter, and it can clear and supplement the spleen Qi, so as to strengthen the spleen Qi. The spleen likes dryness and dislikes dampness, and it is good at transportation. The key is to transport the spleen, and to regulate the spleen and stomach movement, so as to assist the spleen transportation. Cangzhu is good at drying dampness and strengthening the spleen, and it is combined with the nature of the spleen liking dryness and disliking dampness. In addition, the aromatic gas of Cangzhu is good at running and entering the spleen and stomach meridian, and it can strengthen the transportation of the spleen. The Prescription of Bencao Congyuan (Cangzhu) states that: "for the treatment of the spleen, Cangzhu is used". Taizishen and Cangzhu are combined to be the monarch, so as to strengthen the spleen and assist the transportation. Huoxiang and Fuling are the ministers, Fuling can strengthen the spleen, and Huoxiang can invigorate the spleen. They are the key drugs for the treatment of the disharmony between the spleen and stomach, and they are good at invigorating the spleen, removing dampness and assisting the transportation. They can assist Cangzhu in drying dampness and strengthening the spleen, and in invigorating the spleen. In the prescription, Gegen, Qingpi, Shanzha, Laiqianzi, Sanleng and Lianqiao are the adjuvants. Gegen can ascend Yang and promote the stomach Qi, Qingpi can move Qi and resolve accumulation, Shanzha can open the stomach and resolve food retention, and they are combined with Taizishen which can supplement and resolve, so as to resolve without stagnation. If the transportation of the spleen is not healthy, it is easy to hinder the Qi movement and cause food retention and heat. Sanleng can remove the accumulation in the intestines, and fried Laiqianzi can resolve food retention and moisten the intestines and bowels, so as to assist Cangzhu in ascending and descending the Qi movement of the spleen and stomach. Lianqiao is bitter and slightly cold, and it can clear the heat caused by food retention and resolve accumulation. All the drugs are combined to strengthen the spleen, transport the spleen and invigorate the spleen, so as to make the transportation of the spleen healthy. In the prescription, the spleen and Qi are strengthened, and the intestines and bowels are regulated. The Qi movement of the spleen and stomach is appropriate, and then the Qi movement of the human body is adjusted, so as to make the whole body Qi movement healthy, and the five Zang organs are in harmony. The whole prescription can strengthen the spleen and assist the transportation. BRIEF DESCRIPTION OF DRAWINGS

[0015] Figure 1 PASS running results. DETAILED DESCRIPTION

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

[0017] Example 1: A traditional Chinese medicine composition for treating infantile anorexia (I)

[0018] Taizishen 9 parts, Cangzhu 9 parts, Fuling 9 parts, Huoxiang 9 parts, Gegen 9 parts, Qingpi 9 parts, Laiqianzi 9 parts, Lianqiao 6 parts, Sanleng 9 parts, and Shanzha 9 parts.

[0019] Example 2: A traditional Chinese medicine composition for treating infantile anorexia (II)

[0020] Taizishen 9 parts, Cangzhu 7 parts, Fuling 11 parts, Huoxiang 8 parts, Gegen 10 parts, Qingpi 9 parts, Laiqianzi 6 parts, Lianqiao 8 parts, Sanleng 8 parts, and Shanzha 10 parts.

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

[0022] Radix pseudoginseng 7 parts, Atractylodes 11 parts, Poria 8 parts, Agastache 10 parts, Pueraria 9 parts, Pericarpium Citri Reticulatae Viride 7 parts, Semen Raphani 13 parts, Forsythia 5 parts, Sparganium 10 parts, Crataegus 9 parts.

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

[0024] Radix pseudoginseng 11 parts, Atractylodes 8 parts, Poria 10 parts, Agastache 9 parts, Pueraria 7 parts, Pericarpium Citri Reticulatae Viride 11 parts, Semen Raphani 7 parts, Forsythia 7 parts, Sparganium 9 parts, Crataegus 7 parts.

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

[0026] Radix pseudoginseng 8 parts, Atractylodes 10 parts, Poria 9 parts, Agastache 7 parts, Pueraria 11 parts, Pericarpium Citri Reticulatae Viride 8 parts, Semen Raphani 11 parts, Forsythia 6 parts, Sparganium 7 parts, Crataegus 11 parts.

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

[0028] Radix pseudoginseng 10 parts, Atractylodes 9 parts, Poria 7 parts, Agastache 11 parts, Pueraria 8 parts, Pericarpium Citri Reticulatae Viride 10 parts, Semen Raphani 9 parts, Forsythia 4 parts, Sparganium 11 parts, Crataegus 8 parts.

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

[0030] Radix pseudoginseng 9 parts, Atractylodes 11 parts, Poria 8 parts, Agastache 10 parts, Pueraria 9 parts, Pericarpium Citri Reticulatae Viride 7 parts, Semen Raphani 13 parts, Forsythia 5 parts, Sparganium 10 parts, Crataegus 9 parts.

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

[0032] Radix pseudoginseng 7 parts, Atractylodes 8 parts, Poria 10 parts, Agastache 9 parts, Pueraria 7 parts, Pericarpium Citri Reticulatae Viride 11 parts, Semen Raphani 7 parts, Forsythia 7 parts, Sparganium 9 parts, Crataegus 7 parts.

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

[0034] Radix pseudoginseng 11 parts, Atractylodes 10 parts, Poria 9 parts, Agastache 7 parts, Pueraria 11 parts, Pericarpium Citri Reticulatae Viride 8 parts, Semen Raphani 11 parts, Forsythia 6 parts, Sparganium 7 parts, Crataegus 11 parts.

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

[0036] Radix Pseudoginseng 8 parts, Atractylodes 9 parts, Poria 7 parts, Agastache 11 parts, Radix Puerariae 8 parts, Pericarpium Citri Reticulatae Viride 10 parts, Semen Raphani 9 parts, Forsythia 4 parts, Sparganium 11 parts, Crataegus 8 parts.

[0037] Example 11 A traditional Chinese medicine composition for treating anorexia in children (eleven)

[0038] Radix Pseudoginseng 10 parts, Atractylodes 7 parts, Poria 11 parts, Agastache 8 parts, Radix Puerariae 10 parts, Pericarpium Citri Reticulatae Viride 9 parts, Semen Raphani 6 parts, Forsythia 8 parts, Sparganium 8 parts, Crataegus 10 parts.

[0039] Example 12 A method for using a traditional Chinese medicine composition for treating anorexia in children

[0040] Method for use: Take any one of the traditional Chinese medicine compositions of Examples 1-11; use hot water to rinse and take, a total of 200 ml, take twice a day in the morning and evening.

[0041] The traditional Chinese medicine formula is mainly used for anorexia in children, with symptoms of loss of appetite, aversion to food and even refusal to eat. Pale complexion, spirit is acceptable, tasteless, sometimes salivation, belching, nausea, loose stools, etc., tongue and pulse fingerprint: tongue is light red, thin white or greasy, pulse is soft, and fingerprint is light red.

[0042] Example 13 Clinical experiment

[0043] 1.1 Research object

[0044] The cases in this test come from children who visited the pediatric outpatient department of Shanghai University of Traditional Chinese Medicine Affiliated City Hospital of Traditional Chinese Medicine from March 2023 to December 2023. Using random number method, children who meet the inclusion criteria are divided into treatment group and control group. Before enrollment, the legal guardians and children are fully informed, and the informed consent form is signed at the same time.

[0045] 1.2 Sample size calculation

[0046] Referring to the literature, previous studies show that the effective rate of traditional Chinese medicine treatment is 95%, and the effective rate of Xingpi Yang'er Granules is 77.5%. Using two-sided test, set α = 0.05, confidence level is 80%, using PASS2021 software to calculate N(treatment group) = 71 cases, N(control group) = 71 cases (see Figure 1 ). Assuming that the loss rate of research subjects is 10%, the sample size N(treatment group) = 71 ÷ 0.9 = 79 cases, N(control group) = 71 ÷ 0.9 = 79 cases. Finally, 79 cases of research subjects were enrolled in the treatment group, and 79 cases were enrolled in the control group, a total of at least 158 cases of research subjects were enrolled.

[0047] 1.3 Western medicine diagnostic criteria

[0048] Referring to Zhu Futang's Practical Pediatrics (9th edition):

[0049] (1) Age: children under the age of 14.

[0050] (2) Appetite decreased significantly, not to eat even refuse to eat, food intake than in the past significantly reduced; 3 years of age children daily food, rice, bread and other cereal intake of less than 50 g, 3 years of age children daily cereal intake of less than 75 g, while meat, eggs, milk intake is very small.

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

[0052] (4) Growth and development: except genetic factors, the height and weight of children are lower than the average level of the same age, and the height and weight of children during the period of anorexia do not show significant growth.

[0053] 1.4 Diagnosis criteria of TCM

[0054] Refer to the criteria of children anorexia with spleen dysfunction syndrome developed by the Society of Traditional Chinese Medicine of the People's Republic of China in 2012:

[0055] Main symptoms: children with poor appetite, dislike eating even refuse to eat.

[0056] Accompanying symptoms: pale complexion, spirit, tasteless, sometimes salivation, belching, nausea, soft stool, tongue and pulse fingerprint: tongue red, white or greasy, pulse, fingerprint red.

[0057] With main symptoms + 4 accompanying symptoms, reference tongue and pulse fingerprint.

[0058] 1.5 Inclusion criteria

[0059] (1) Meet the conditions of children anorexia.

[0060] (2) TCM syndrome belongs to spleen dysfunction syndrome.

[0061] (3) Age 1-12 years old, can complete the treatment.

[0062] (4) The course of the disease is more than 4 weeks.

[0063] (5) The informed consent process meets the requirements, and the legal guardian signs the informed consent form.

[0064] 1.6 Exclusion criteria

[0065] (1) Anorexia caused by disease, such as acute and chronic gastroenteritis, peptic ulcer, respiratory tract infection, acute and chronic hepatitis, anorexia nervosa and some drug-induced anorexia.

[0066] (2) Moderate and severe malnutrition children belong to TCM malnutrition syndrome.

[0067] (3) Combined severe primary diseases of heart, liver, kidney, digestive system and hematopoietic system, etc.

[0068] (4) Allergic to the test drug or its components.

[0069] (5) Other diseases or conditions that reduce the possibility of enrollment or complicate the enrollment according to the judgment of the researchers, such as unstable living environment, inconvenient transportation, etc., which are prone to cause loss of follow-up.

[0070] 1.7 Dropout Criteria

[0071] 1.7.1 Withdrawal by the Investigator

[0072] (1) The occurrence of anaphylaxis or serious adverse events that should stop the trial according to the judgment of the doctor.

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

[0074] (3) Poor compliance of the child subject (trial drug compliance < 80% or > 120%), or automatic replacement of medication or addition of prohibited Chinese and Western medicines.

[0075] 1.7.2 Withdrawal by the Child Subject

[0076] (1) The child or his legal guardian is unwilling or unable to continue the clinical trial for any reason, and the trial is discontinued at the request of the principal investigator.

[0077] (2) The child subject no longer receives medication and detection and is lost to follow-up without explicitly requesting to withdraw from the trial.

[0078] 1.8 Exclusion Criteria

[0079] (1) After randomization, it is found that the inclusion criteria or exclusion criteria are seriously violated.

[0080] (2) After randomization, no medication has been used or no post-treatment follow-up records have been recorded.

[0081] (3) Others.

[0082] 1.9 Termination of Clinical Trial

[0083] The trial is terminated due to serious safety events, significant errors in the clinical trial protocol, or significant deviations in the implementation of the protocol that make it difficult to evaluate the efficacy of the drug. The trial should be terminated if the drug treatment is found to be less effective and not clinically valuable.

[0084] 2. Research Methods

[0085] 2.1 Grouping method

[0086] 158 cases of anorexia children were collected in the pediatric outpatient department of Shanghai University of Traditional Chinese Medicine Affiliated City Hospital of Traditional Chinese Medicine. According to the order of treatment, the case number was set as 1 ～ 158, using SPSS25.0 software to generate a random number table, and randomly grouping the random numbers from small to large, from low to high according to the sequence number into the treatment group and the control group.

[0087] 2.2 Treatment method

[0088] Treatment group: Taizishen 9 parts, Cangzhu 9 parts, Fuling 9 parts, Huoxiang 9 parts, Gegen 9 parts, Qingpi 9 parts, Laihu 9 parts, Lianqiao 6 parts, Sanleng 9 parts, Shanzha 9 parts; 200ml of boiling water is used to open and take, and is taken twice a day. More than 3 years old, 1 / 2 of the amount of the prescription is used.

[0089] Control group: Xingsi Yang'er Granules

[0090] Method and dosage: 1-2 year-old children, 2 bags at a time, 2 times a day; 3-6 year-old children, 2 bags at a time, 3 times a day; 7-12 year-old children, 3-4 bags at a time, 2 times a day.

[0091] This study is 2 weeks for a course of treatment, and 2 courses of treatment are given.

[0092] The above required traditional Chinese medicines are purchased from the Granule Pharmacy of the Pharmacy Department of Shanghai University of Traditional Chinese Medicine Hospital, produced by Sichuan Xinlv Pharmaceutical Co., Ltd.

[0093] The Xingsi Yang'er Granules used in this study (Guizhou Jianxing Pharmaceutical Co., Ltd., approval number: National Drug Standard Z20025415) mainly contain: one red, large dengcao, shanzhite, spider herb.

[0094] 2.3 Observation index

[0095] 2.3.1 General situation

[0096] Record the age, sex, disease course, height, weight, etc. of the children;

[0097] 2.3.2 Main efficacy index

[0098] Record the appetite and food intake of the children before treatment and 4 weeks after treatment;

[0099] 2.3.3 Secondary reference index

[0100] Observe the children's complexion, spirit, tasteless, saliva, belching, hiccups, nausea, soft stool, etc. (TCM clinical symptom score table (Appendix 1)) before treatment and 4 weeks after treatment, and score the children's eating behavior scale (Appendix 2).

[0101] 2.3.4 Treatment group adverse reactions

[0102] Observation records of children using the traditional Chinese medicine prescription during the period of adverse reactions.

[0103] 2.4 Efficacy evaluation

[0104] Refer to the "Guiding Principles for Clinical Research of New Drugs of Traditional Chinese Medicine (Trial)" to develop the efficacy evaluation criteria as follows:

[0105] Clinical recovery: TCM clinical symptoms and signs disappear or basically disappear, and syndrome score reduction ≥95%;

[0106] Marked effect: Most TCM clinical symptoms and signs disappear, and syndrome score reduction ≥70% but <95%;

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

[0108] Ineffective: TCM clinical symptoms and signs have no obvious improvement, or even worsen, and syndrome score reduction is less than 30%.

[0109] Note: TCM syndrome score and = loss of appetite + reduced food intake + mental status + pale complexion + tasteless and bland + salivation + belching and hiccups + nausea + soft and sloppy stools; Syndrome score reduction rate = [(pre-treatment syndrome score and - post-treatment syndrome score and) / pre-treatment syndrome score and] x 100%.

[0110] 3. Data entry and statistical methods

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

[0112] All data of this trial are statistically processed using SPSS 26.0 software, with a two-sided test and a test level α = 0.05, P < 0.05 is considered to have statistical significance. Measurement data are represented as mean ± standard deviation , conforming to normal distribution and homogeneity of variance using t-test. Rank data comparison uses two independent sample Mann-Whitney U test and two related sample Wilcoxon test, multiple rates or multiple constituent ratios use χ2 test or Fisher's exact probability method. With a two-sided test level, P < 0.05 is considered to have statistical difference.

[0113] 4. Results

[0114] 4.1 Comparison of general data

[0115] A total of 158 children were enrolled in this study, and were randomly divided into control group and treatment group, 79 cases in each. During the study, a total of 9 cases were dropped, including 5 cases in the control group, 3 cases of concurrent bronchial pneumonia, and 2 cases of parents not cooperating later; 4 cases of children in the treatment group were dropped, 3 cases of concurrent acute respiratory infection, and 1 case of parents not cooperating later, a total of 149 cases of children completed the test.

[0116] 4.1.1 Comparison of gender between the two groups of children

[0117] Table 1-1 Gender distribution table

[0118]

[0119]

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

[0121] 4.1.2 Comparison of age between the two groups of children

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

[0123]

[0124] The age of children in the treatment group and the control group was not in normal distribution by normal test, and the rank sum test was used, P>0.05, the statistical result showed that there was no difference in age distribution between the two groups, which was comparable.

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

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

[0127]

[0128] The body weight of children in the treatment group and the control group was in normal distribution, with homogeneity of variance, two independent sample t test was used, P=0.629>0.05, the statistical result showed that there was no difference in body weight distribution between the two groups, which was comparable.

[0129] 4.2 Comparison of clinical syndrome score before treatment

[0130] 4.2.1 Comparison of main symptom score before treatment

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

[0132]

[0133] The data did not meet the normal distribution, and the rank sum test was performed. The comparison of the main symptom scores between the two groups showed P>0.05, and the statistical results suggested that there was no difference in the main symptom scores between the two groups, which was comparable.

[0134] 4.2.2 Comparison of the scores of each secondary symptom before treatment

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

[0136]

[0137] The data did not meet the normal distribution, and the rank sum test was performed. The comparison of the main symptom scores between the two groups showed P>0.05, and the statistical results suggested that there was no difference in the main symptom scores between the two groups, which was comparable.

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

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

[0140]

[0141] The data did not meet the normal distribution, and the rank sum test was performed. The comparison of the main symptom scores between the two groups showed P>0.05, and the statistical results suggested that there was no difference in the main symptom scores between the two groups, which was comparable.

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

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

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

[0145]

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

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

[0148] Table 1-7 Comparison of the secondary symptom syndrome scores between the two groups 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 total symptom scores of the main symptoms, the total symptom scores of the secondary symptoms, and the TCM syndrome scores of the control group and the treatment group were significantly reduced (all P<0.001), indicating that the main symptoms, the secondary symptoms, and the TCM syndromes of the two groups were significantly improved after treatment.

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

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

[0153]

[0154] The data did not meet the normal distribution, so the rank sum test was used. The results showed that the total symptom scores of the main symptoms, the total symptom scores of the secondary symptoms, and the TCM syndrome scores of the control group and the treatment group were significantly reduced (all P<0.001), indicating that the main symptoms, the secondary symptoms, and the TCM syndromes of the two groups were significantly improved after 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 after treatment in two groups of children

[0158]

[0159]

[0160] The data did not meet the normal distribution, so the rank sum test was used. The results showed that the total symptom scores of the main symptoms, the total symptom scores of the secondary symptoms, and the TCM syndrome scores of the control group and the treatment group were significantly reduced (all P<0.001), indicating that the main symptoms, the secondary symptoms, and the TCM syndromes of the two groups were significantly improved after treatment.

[0161] 4.4.2 Comparison of secondary symptom scores after treatment

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

[0163]

[0164] The data did not meet the normal distribution, so the rank sum test was used. The results showed that the total symptom scores of the main symptoms, the total symptom scores of the secondary symptoms, and the TCM syndrome scores of the control group and the treatment group were significantly reduced (all P<0.001), indicating that the main symptoms, the secondary symptoms, and the TCM syndromes of the two groups were significantly improved after treatment.

[0165] 4.4.3 Comparison of total clinical syndrome score after treatment

[0166] Table 1-11 Comparison of clinical syndrome score after treatment in two groups of children

[0167]

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

[0169] 4.5 Comparison of eating behaviors between two groups of children

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

[0171] Table 1-11 Comparison of eating behaviors between two groups before treatment

[0172]

[0173]

[0174] The data did not meet the normal distribution, and the rank sum test was performed. The comparison of overeating response, slow eating and other eating behaviors between the two groups showed P>0.05, indicating that there was no difference in eating behavior scale score between the two groups, and they were comparable.

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

[0176] Table 1-11 Comparison of eating behaviors between two groups before and after treatment

[0177]

[0178]

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

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

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

[0182]

[0183] After treatment, the total effective rate of the control group was 83.78%, of which 6 cases were cured, 14 cases were markedly effective, 42 cases were effective, and 12 cases were ineffective; the total effective rate of the treatment group was 96.00%, of which 18 cases were cured, 32 cases were markedly effective, 22 cases were effective, and 3 cases were ineffective. The difference in total effective rate between the two groups of children was statistically significant (P<0.05), see Table.

[0184] 4.7 Safety comparison

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

[0186] 5 Conclusion

[0187] The results of this study show that the traditional Chinese medicine formula is superior to the control group in terms of total effective rate and improvement of TCM syndrome score, especially in improving symptoms such as loss of appetite, reduced food intake, and symptoms such as salivation, belching, hiccups, nausea, and other symptoms.

[0188] The above is only the preferred embodiment of the present application, it should be noted that for ordinary skilled in the art, without departing from the method of the present application, can make a number of improvements and supplements, these improvements and supplements should also be considered within the scope of the present application.

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 Trigonosciadium japonicum, 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 Trigonosciadium japonicum, and 8-10 parts of Crataegus pinnatifida.

3. 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: 9 parts of Pseudostellariae Radix, 9 parts of Atractylodes Rhizome, 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 Forsythia, 9 parts of Trigonosciadium japonicum 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 traditional 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 medicament 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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