A traditional Chinese medicine composition for treating children functional constipation of qi-yin deficiency type and application thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating children functional constipation of qi-yin deficiency type and application thereof. The traditional Chinese medicine composition comprises, in parts by mass, 8-10 parts of radix pseudostellariae, 8-10 parts of prepared rehmannia, 8-10 parts of scrophularia, 8-10 parts of raw rehmannia, 5-7 parts of ophiopogon, 8-10g of raw atractylodes, 5-7 parts of pericarpium citri reticulatae, 2-4 parts of cassia, 5-7 parts of fried fructus aurantii, 5-7 parts of cannabis sativa, and 2-4 parts of licorice. The traditional Chinese medicine composition is used for treating children functional constipation of qi-yin deficiency type.

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine compound for treating functional constipation in children. Background Technology

[0002] Constipation is characterized by dry, hard stools, infrequent bowel movements (>2 days), or the inability to defecate despite the urge. Clinically, childhood constipation can be divided into two main categories: functional constipation (FC) and organic constipation, with FC accounting for over 90% of childhood constipation cases. This invention refers to childhood FC. The global prevalence of this disease in children is 3-30%, while a meta-analysis in China showed an overall prevalence of 6.0% in children, making it a common and frequently occurring disease among children's spleen system disorders. The pathogenesis and mechanisms of FC are complex and remain inconclusive.

[0003] Constipation in children is often accompanied by abdominal pain and bloating, loss of appetite, nausea and vomiting; in severe cases, it can even lead to anal fissures and rectal prolapse. Furthermore, prolonged constipation can weaken the immune system, manifesting as recurrent upper respiratory tract infections and tonsillitis. It can also affect a child's development, causing memory loss and difficulty concentrating. Some children may also experience bedwetting due to abnormal rectal distension compressing the bladder, severely impacting their physical and mental development.

[0004] Currently, Western medicine drug treatments mainly include laxatives, intestinal probiotics, and gastrointestinal motility drugs, which have problems such as easy recurrence of symptoms after discontinuation, easy dependence, and unsatisfactory long-term efficacy. Summary of the Invention

[0005] The main objective of this invention is to provide a traditional Chinese medicine compound for treating febrile fibroids (FC) in children with qi and yin deficiency.

[0006] The technical solution adopted by this invention to solve its technical problem is:

[0007] A traditional Chinese medicine compound, comprising, by mass parts:

[0008] 8-10 parts of Codonopsis pilosula; 8-10 parts of Rehmannia glutinosa (processed); 8-10 parts of Scrophularia ningpoensis; 8-10 parts of Rehmannia glutinosa (raw);

[0009] Ophiopogon japonicus 5-7 parts; Atractylodes macrocephala 8-10g; Citrus reticulata peel 5-7 parts; Cinnamomum cassia 2-4 parts;

[0010] 5-7 parts of stir-fried immature bitter orange; 5-7 parts of hemp seed; 2-4 parts of licorice.

[0011] Furthermore, the traditional Chinese medicine complex comprises, by mass percentage:

[0012] Codonopsis pilosula 9 parts; Rehmannia glutinosa (processed) 9 parts; Scrophularia ningpoensis 9 parts; Rehmannia glutinosa (raw) 9 parts;

[0013] Ophiopogon japonicus 6 parts; Atractylodes macrocephala 9 parts; Citrus reticulata peel 6 parts; Cinnamomum cassia 3 parts;

[0014] Stir-fried immature bitter orange (6 parts); hemp seed (6 parts); licorice root (3 parts).

[0015] Furthermore, each dose of the traditional Chinese medicine compound is equivalent to 64g-86g of raw materials.

[0016] The present invention also provides the use of the aforementioned traditional Chinese medicine compound in the preparation of a pediatric constipation medication.

[0017] Furthermore, the aforementioned childhood constipation is FC.

[0018] Furthermore, the aforementioned childhood constipation is FC of the Qi and Yin deficiency type.

[0019] Furthermore, the dosage form of the traditional Chinese medicine complex includes decoctions, pills, powders, tablets, ointments, granules, capsules, or oral liquids. Granules are preferred.

[0020] Furthermore, for children aged 1 to 3 years, the dosage is 1 / 2 dose daily; for children aged 4 to 6 years, the dosage is 2 / 3 dose daily; for children aged 7 to 14 years, the dosage is 1 dose daily, dissolved in 100ml of boiled water and taken warm half an hour after meals, twice a day.

[0021] The key features of this invention are as follows: Traditional Chinese medicine has a long history of understanding constipation. This condition was first mentioned in the *Huangdi Neijing* (Yellow Emperor's Inner Classic), described as "difficulty in defecation" or "difficulty in passing stool." The *Shanghan Zabing Lun* (Treatise on Febrile and Miscellaneous Diseases) refers to it as "not defecating," "yin constipation," "yang constipation," or "spleen contraction," making it the earliest work to classify constipation according to yin and yang. The *Beiji Qianjin Yaofang* (Essential Prescriptions Worth a Thousand Gold Pieces) records "difficulty in defecation" and "inability to defecate," suggesting that the two expressions only differ in degree. The *Danxi Xinfa* (Danxi's Heart Method) names it "dryness and constipation." The *Jingyue Quanshu* (Complete Works of Jingyue) records it as "constipation and constipation," and provides a detailed classification of its diagnosis and treatment. The term "constipation" first appeared in the book *Zabing Yuanliu Xizhu* (A Comprehensive Guide to Miscellaneous Diseases) and has been used ever since.

[0022] Constipation originates in the large intestine, which is the body's main organ for transmission, responsible for the formation and excretion of stool. However, constipation is related to the functions of the heart, lungs, spleen, stomach, liver, and kidneys. Children are considered to have immature yin and yang, and their spleen is often deficient. If the spleen and stomach are not fully developed, or if qi is deficient and body fluids do not circulate smoothly, it can easily affect the transmission of waste in the large intestine, leading to constipation. The *Huangdi Neijing* states: "The spleen and stomach are the foundation of acquired constitution. Food enters the stomach, and the spleen transforms it into the essence of water and grain, which is then distributed throughout the body as qi, blood, and body fluids, nourishing all the organs." If the spleen and stomach are deficient in qi, food cannot be properly digested after entering the stomach. This results in insufficient distribution of essential nutrients throughout the body, leading to malnourishment of the internal organs. In the intestines, this manifests as reduced intestinal fluids and decreased lubrication, causing dry stools that accumulate and lead to constipation. Secondly, the spleen governs digestion and transportation; spleen deficiency reduces intestinal peristalsis, causing stool to remain in the intestines and prolonging the interval between bowel movements. If this time is prolonged, the intestines absorb water from the stool, making it even drier and further hindering defecation. Western medicine believes that constipation is related to the anatomy and physiology of the child's intestines. Children's intestines are relatively long, their intestinal wall elastic fibers and muscle layers are underdeveloped, their peristalsis is insufficient, and their intestinal muscle tone is low, all of which contribute to prolonged food residue retention, water absorption, and hardened stools that are difficult to pass. This shares some similarities with the pathogenesis described in Traditional Chinese Medicine (TCM) as qi deficiency leading to impaired digestion, insufficient body fluids, dysfunction of the large intestine's transmission function, and retention of waste products.

[0023] This invention is a modification of the Four Gentlemen Decoction combined with the Intestinal Moistening Decoction, and has the effects of replenishing qi and nourishing yin, moistening the intestines and promoting bowel movements. The formula uses Codonopsis pilosula, which is sweet and neutral, replenishing without causing dryness, benefiting qi and nourishing yin, strengthening the spleen and generating fluids; Rehmannia glutinosa, which is sweet and slightly warm, replenishing blood and nourishing yin, "greatly replenishing blood deficiency, greatly replenishing the true yin of the five internal organs, and greatly replenishing yin water," and the two together serve as the principal herbs, working together to benefit qi and nourish yin. Atractylodes macrocephala, which is sweet, bitter, and warm, strengthens the spleen, replenishes the middle jiao and benefits qi, and strengthens the source of qi and blood production; at the same time, it can also generate "stomach and intestinal fluids," thus having the effects of generating fluids, promoting bowel movements, and moistening the intestines. Citrus reticulata, which is bitter, pungent, and warm, regulates qi and strengthens the spleen, ensuring that the replenishment is not stagnant. Ophiopogon japonicus, which is sweet, slightly bitter, and slightly cold, "is best for nourishing stomach yin and generating fluids." Scrophularia ningpoensis, which is sweet and slightly bitter, nourishes yin and moistens dryness, opening kidney water to moisten intestinal dryness; Rehmannia glutinosa, which is sweet and cold, strengthens water and generates fluids, thus enhancing the moistening effect of Scrophularia ningpoensis. Hemp seed enters the spleen, stomach, and large intestine meridians, nourishing stomach yin and moistening the intestines to relieve constipation. The six herbs used together form the assistant herbs: Atractylodes macrocephala and Citrus reticulata peel assist Codonopsis pilosula in strengthening the spleen; Hemp seed, Rehmannia glutinosa (raw and prepared) are from the "Intestinal Moistening Decoction" in *Lan Shi Mi Cang*, working together to nourish yin and moisten the intestines; Ophiopogon japonicus, Rehmannia glutinosa (raw), and Scrophularia ningpoensis nourish yin and increase fluids, moistening the intestines and promoting bowel movements, thus aiding in the flow of fluids. Cinnamon is pungent, sweet, and hot, warming yang and invigorating qi and blood; stir-fried Citrus aurantium regulates qi and relieves stagnation, promoting the body's qi mechanism, ensuring the tonifying effects of the herbs are not stagnant, thus serving as the adjuvant herbs; Licorice root is sweet and slightly cool, acting as the guiding herb to harmonize the effects of the other herbs.

[0024] This invention takes a holistic approach, not focusing solely on constipation itself, but emphasizing the regulation of Qi, blood, and body fluids. Previous Chinese medicine treatments for childhood constipation often addressed issues like food stagnation, dryness, and Qi stagnation. However, this invention, "Shen Di Er Bian Shu," addresses the unique characteristics of children's internal organs, recognizing their immature organ development, insufficient Qi, blood, and body fluid production, and the resulting lack of Qi propulsion and lubrication in the intestines, leading to difficult-to-pass stools. It argues that Qi and Yin deficiency is a significant cause of childhood constipation, thus proposing a treatment principle of tonifying and opening the bowels, using Qi-tonifying, Yin-nourishing, and bowel-moistening methods. This invention utilizes "Shen Di Er Bian Shu" to treat childhood constipation caused by Qi and Yin deficiency. This formula combines various herbs to address both the root cause and the symptoms, focusing on regulating Yin and Yang, Qi, Blood, and Body Fluids. It strengthens the source of Qi and Blood production, seeking Yin within Yang, and addresses blockages by addressing their underlying causes, thus relieving constipation and promoting bowel movement. This combination nourishes Yin and replenishes Qi, promoting bowel movement and relieving dryness. It is suitable for children with constipation due to Qi and Yin deficiency, characterized by dry stools, difficulty defecating, spontaneous sweating, night sweats, poor appetite, and poor sleep. Years of clinical experience have demonstrated its significant efficacy. Detailed Implementation

[0025] Example 1

[0026] A traditional Chinese medicine compound for treating febrile fibroids (FC) in children with qi and yin deficiency (hereinafter referred to as Shendierbianshu) has the following components:

[0027] Codonopsis pilosula 9g, Rehmannia glutinosa (processed) 9g, Scrophularia ningpoensis 9g, Rehmannia glutinosa (raw) 9g

[0028] Ophiopogon japonicus 6g, Atractylodes macrocephala 9g, Citrus reticulata peel 6g, Cinnamomum cassia 3g

[0029] 6g of stir-fried immature bitter orange, 6g of hemp seed, and 3g of licorice root.

[0030] Example 2

[0031] A traditional Chinese medicine compound for treating febrile fibroids (FC) in children with qi and yin deficiency (hereinafter referred to as Shendierbianshu) has the following components:

[0032] Codonopsis pilosula 8g, Rehmannia glutinosa (processed) 10g, Scrophularia ningpoensis 8g, Rehmannia glutinosa (raw) 10g

[0033] Ophiopogon japonicus 5g, Atractylodes macrocephala 10g, Citrus reticulata peel 5g, Cinnamomum cassia 4g

[0034] 5g of stir-fried immature bitter orange, 7g of hemp seed, and 2g of licorice root

[0035] Example 3

[0036] A traditional Chinese medicine compound for treating febrile fibroids (FC) in children with qi and yin deficiency (hereinafter referred to as Shendierbianshu) has the following components:

[0037] Codonopsis pilosula 10g, Rehmannia glutinosa (processed) 8g, Scrophularia ningpoensis 10g, Rehmannia glutinosa (raw) 8g

[0038] Ophiopogon japonicus 7g, Atractylodes macrocephala 8g, Citrus reticulata peel 7g, Cinnamomum cassia 2g

[0039] 7g of stir-fried immature bitter orange, 5g of hemp seed, and 4g of licorice root.

[0040] Source of cases

[0041] The cases in this study were children aged 1-14 years with FC (fibrillary fibrosis) due to Qi and Yin deficiency who visited the pediatric outpatient department of Xiamen Municipal Hospital of Traditional Chinese Medicine between January 2022 and November 2022.

[0042] Case selection criteria

[0043] Diagnostic criteria

[0044] Western medicine diagnostic criteria: formulated with reference to the Rome IV criteria for functional gastrointestinal disorders in children.

[0045] Traditional Chinese Medicine (TCM) syndrome differentiation diagnostic criteria: formulated with reference to the "Expert Consensus on the Diagnosis and Treatment of Constipation with Traditional Chinese Medicine 2017" and the "Consensus on the Diagnosis and Treatment of Functional Constipation with Integrated Traditional Chinese and Western Medicine (2017)".

[0046] Inclusion criteria

[0047] (1) Meets the diagnostic criteria of Western medicine;

[0048] (2) Meets the diagnostic criteria for Qi and Yin deficiency syndrome in Traditional Chinese Medicine;

[0049] (3) Age of the patient: 1 year old ≤ age ≤ 14 years old;

[0050] (4) Sign the informed consent form (children aged 1-7 years must have informed consent from their guardians, and children aged 8-14 years must have informed consent from themselves).

[0051] Exclusion criteria

[0052] (1) Constipation caused by organic diseases of the digestive tract, such as congenital megacolon, anal stenosis, intestinal tumors, etc.;

[0053] (2) Secondary constipation caused by other systems, such as endocrine and metabolic diseases, nervous system diseases, intestinal nerve and muscle diseases, connective tissue diseases, abdominal muscle abnormalities, etc.;

[0054] (3) Constipation caused by medication, such as morphine and other sedative analgesics;

[0055] (4) Those suffering from serious primary diseases, such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system diseases, etc.;

[0056] (5) Those suffering from mental illness.

[0057] Removal and shedding criteria

[0058] (1) Children who were included in the trial but did not receive treatment according to the prescribed trial protocol;

[0059] (2) Children who were treated with other drugs or methods during the trial, which affected the determination of efficacy;

[0060] (3) Children who were lost to follow-up or did not attend follow-up visits on time during the trial period;

[0061] (4) Children whose data is missing and whose results cannot be analyzed.

[0062] Case termination criteria

[0063] (1) If a child experiences drug allergy, adverse reactions, or special physiological changes during the trial, the trial should be stopped immediately;

[0064] (2) Children who are unwilling to continue treatment during the trial and voluntarily request to withdraw from the clinical trial.

[0065] Note: If the child has three bowel movements per week during the trial and there is no fecal incontinence, the treatment is considered successful and the trial can be terminated.

[0066] Case grouping

[0067] Children with febrile follicle syndrome (FC) treated at the Pediatric Outpatient Department of Xiamen Municipal Hospital of Traditional Chinese Medicine from January 2022 to November 2022 were selected. Based on the diagnostic criteria for Qi and Yin deficiency in Traditional Chinese Medicine, 72 children were randomly divided into an observation group and a control group. A random number table was used. Children were numbered sequentially according to their order of visit. Starting from any number in the table, random numbers were generated for each case in the same direction. These numbers were then rearranged in ascending order. The first 36 cases were assigned to the observation group, and the latter 36 cases to the control group. When eligible FC children entered the trial in the prescribed order, the trial was conducted strictly according to the established group assignments without any changes.

[0068] Treatment

[0069] 1. Basic treatment

[0070] Both groups received the following basic treatment:

[0071] (1) Establish good bowel habits. The main principles are fixed time, fixed location, and regular bowel movements.

[0072] (2) Arrange your diet reasonably and ensure adequate intake of water and dietary fiber.

[0073] (3) Relieve psychological barriers and encourage children to defecate.

[0074] 2 Observation Group

[0075] The prescription for the Ginseng and Dioscorea Bupleurum Decoction in Example 1 is as follows:

[0076] Codonopsis pilosula 9g, Rehmannia glutinosa (processed) 9g, Scrophularia ningpoensis 9g, Rehmannia glutinosa (raw) 9g

[0077] Ophiopogon japonicus 6g, Atractylodes macrocephala 9g, Citrus reticulata peel 6g, Cinnamomum cassia 3g

[0078] 6g of stir-fried immature bitter orange, 6g of hemp seed, and 3g of licorice root.

[0079] Soak the above medicines in 200ml of water for 30 minutes. For the first decoction, bring to a boil over high heat, then simmer over low heat for 20 minutes and pour out the liquid. For the second decoction, add about 200ml of water, bring to a boil over high heat, then simmer over low heat for 30 minutes. Mix the two decoctions together and take orally in 2-3 doses (half the dose for children aged 1-3 years, two-thirds the dose for children aged 4-6 years, and the full dose for children aged 7-14 years).

[0080] 3. Control Group

[0081] Lactulose oral solution (200ml / bottle, Imported drug registration standard: JX20170031, Manufacturer: Abbott Healthcare Products BV).

[0082] Dosage and administration: 1-6 years old: 7.5ml / time; 7-14 years old: 15ml / time, orally, once a day.

[0083] 4. Observation time

[0084] Both treatment courses lasted for 3 weeks, with weekly follow-up visits during which TCM syndrome scores and safety indicators were recorded, for a total of 3 follow-up visits.

[0085] 5 Observation Indicators

[0086] 5.1 Treatment effectiveness rate: clinical cure, significant effect and effective status.

[0087] 5.2 Main symptoms: Stool characteristics, difficulty in defecation, and frequency of defecation before and after treatment.

[0088] Stool characteristics: Stools were graded according to the Bristol Stool Scale: Grade 1 was loose, hard lumps, resembling nuts or sheep droppings; Grade 2 was sausage-shaped, like a dried, hard banana; Grade 3 was sausage-shaped, but with visible cracks on the surface; Grade 4 was sausage-shaped or snake-shaped, soft and smooth; Grade 5 was a soft mass with clear edges; Grade 6 was a loose mass with indistinct edges, or porridge-like; Grade 7 was watery stool, with no visible solid components. Grades 1, 2, 3, 6, and 7 were considered abnormal stool characteristics, while grades 4 and 5 were considered normal. In this clinical efficacy observation, grades 1, 2, and 3 were recorded as 6, 4, and 2 points respectively, while all other grades were recorded as 0 points.

[0089] Difficulty in defecation and excessive straining during defecation: Record as 0, 2, 4, or 6 points, depending on whether it is absent, occasional, sometimes, or frequently.

[0090] Bowel movement frequency: 1-2 times / day, 0 points; 3 times / day, 2 points; 4-5 times / day, 4 points; >6 times / day, 6 points.

[0091] 5.3 Secondary symptoms: fatigue, abdominal distension, abdominal pain, dry mouth, spontaneous sweating and night sweats before and after treatment.

[0092] All five sub-symptoms above are recorded as follows: none, occasional, sometimes, and often, with scores of 0, 1, 2, and 3 respectively.

[0093] 6. Adverse Reactions

[0094] Are there any adverse reactions such as nausea, vomiting, diarrhea, rash, or shortness of breath?

[0095] 7. Methods for evaluating therapeutic effects

[0096] Formulated with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs" (2002 edition).

[0097] 8. Data Statistical Analysis

[0098] Data processing was performed using SPSS 26.0 statistical software. If the quantitative data were normally distributed, the mean ± standard deviation was used. Statistical description was performed; t-tests were used for statistical analysis. If the statistically analyzed data showed a skewed distribution, the median and quartiles were used as the statistical indicators. Statistical description was performed; the rank-sum test was used for statistical analysis. The rank-sum test was used for ordered ordinal data, and the rank-sum test was used for unordered categorical qualitative data. Test. P < 0.05 indicates that the two difference coefficients have certain statistical significance (determined by coefficient α = 0.05).

[0099] result

[0100] 1. Completion status of the two groups of cases

[0101] A total of 72 cases were collected, with 4 cases dropped out or excluded after inclusion. Among them, 2 cases dropped out in the observation group, and 1 case dropped out and 1 case was excluded in the control group. Finally, 68 cases were collected, with 34 cases in the observation group and 34 cases in the control group, and the completion rate of both groups was 94.44%.

[0102] 2. Comparison of overall efficacy between the two groups

[0103] After 3 weeks of treatment, the total effective rate in the observation group was 91%, while the total effective rate in the control group was 82%. The observation group was significantly higher than the control group (P < 0.05).

[0104] Table 1. Comparison of therapeutic effects of TCM syndromes in the two groups (cases, %)

[0105]

[0106] Note: According to the Wilcoxon two independent samples rank-sum test, P < 0.05.

[0107] 3. Comparison of scores between the two groups before and after treatment, and after 3 weeks of treatment.

[0108] 3.1 Comparison of the total scores of primary symptoms, secondary symptoms, and syndromes in the two groups of TCM.

[0109] The differences in the total scores of primary symptoms, secondary symptoms, and syndromes in TCM between the two groups before and after treatment were statistically significant (P < 0.05).

[0110] After 3 weeks of treatment, the differences in the main symptoms, secondary symptoms and total syndrome scores between the two groups were statistically significant (P < 0.05).

[0111] Table 2 Comparison of total TCM scores before and after treatment, and after 3 weeks of treatment in the two groups (M (P) 25 P 75 )],point)

[0112]

[0113] Note a: Within-group comparison before and after treatment, *P<0.05.

[0114] The total score of the main symptoms was determined by paired-samples rank-sum test, and the results showed that the observation group had a P=0.000<0.05, while the control group had a P=0.000<0.05.

[0115] The total score of secondary symptoms was determined by paired-samples rank-sum test, and the result was P=0.000<0.05 for the observation group; and P=0.000<0.05 for the control group by paired-samples t-test.

[0116] The total syndrome score was determined by paired-samples rank-sum test, and the result was P=0.000<0.05 for the observation group; and P=0.000<0.05 for the control group by paired-samples t-test.

[0117] Note b: Comparison between the two groups after 3 weeks of treatment. # P < 0.05.

[0118] According to the Wilcoxon two independent samples rank-sum test, the total score of the main symptom was P=0.018<0.05; the total score of the secondary symptom was P=0.030<0.05; and the total score of the syndrome was P=0.028<0.05.

[0119] 3.2 Comparison of individual scores for the main symptoms in TCM between the two groups

[0120] The differences in stool characteristics, defecation difficulty, and defecation frequency scores between the two groups before and after treatment were statistically significant (P < 0.05).

[0121] After 3 weeks of treatment, there were statistically significant differences in stool characteristics and defecation difficulty scores between the two groups (P < 0.05); however, there were no statistically significant differences in defecation frequency scores between the two groups (P > 0.05).

[0122] Table 3. Comparison of individual scores of TCM main symptoms between the two groups before and after treatment, and after 3 weeks of treatment ([M(P)]) 25 P 75 )],point)

[0123]

[0124] Note a: Within-group comparison before and after treatment, *P<0.05.

[0125] According to the paired sample rank-sum test, the differences in stool characteristics, defecation difficulty, and defecation frequency between the two groups were P=0.000<0.05.

[0126] Note b: Comparison between the two groups after 3 weeks of treatment. # P < 0.05.

[0127] Wilcoxon's two independent samples rank-sum test showed that stool characteristics (P=0.030<0.05) and defecation difficulty (P=0.034<0.05); the defecation frequency integral... ▲ P=0.102>0.05.

[0128] 3.3 Comparison of individual scores for secondary symptoms in the two groups of traditional Chinese medicine

[0129] In the control group, there were statistically significant differences in scores for abdominal distension, abdominal pain, dry mouth, spontaneous sweating, and night sweats before and after treatment (P < 0.05); however, there were no statistically significant differences in scores for fatigue and weakness within the control group (P > 0.05). In the observation group, there were statistically significant differences in scores for fatigue and weakness, abdominal distension, abdominal pain, dry mouth, spontaneous sweating, and night sweats within the observation group (P < 0.05).

[0130] After 3 weeks of treatment, there were statistically significant differences in the scores of fatigue, spontaneous sweating and night sweats between the two groups (P < 0.05); however, there were no statistically significant differences in the scores of abdominal distension, abdominal pain, dry mouth and reduced saliva between the two groups (P > 0.05).

[0131] Table 4. Comparison of TCM secondary symptom scores between the two groups before and after treatment, and after 3 weeks of treatment ([M(P)]). 25 P 75 )],point)

[0132]

[0133] Note a: Within-group comparison before and after treatment, *P<0.05.

[0134] Paired-samples rank-sum test showed that in the control group, the scores for abdominal distension, abdominal pain, dry mouth, spontaneous sweating, and night sweats were P=0.000<0.05, and the score for fatigue was... ◆P=0.083>0.05; In the observation group, symptoms such as fatigue, abdominal distension, abdominal pain, dry mouth, spontaneous sweating, and night sweats were P=0.000<0.05.

[0135] Note b: Comparison between the two groups after 3 weeks of treatment. # P < 0.05.

[0136] Wilcoxon's two independent samples rank-sum test showed that fatigue (P=0.000<0.05) and spontaneous sweating / night sweats (P=0.010<0.05) were observed; abdominal distension... ▲ P=0.085>0.05, abdominal pain ▲ P=0.116>0.05, dry mouth and reduced saliva integral ▲ P=0.497>0.05.

[0137] 4. Adverse reaction evaluation

[0138] In this clinical study, the vital signs of both groups of children remained stable during the treatment period, and no nausea, vomiting, diarrhea, rash, shortness of breath or other adverse reactions occurred.

[0139] The above description is merely a preferred embodiment of the present invention, and therefore should not be construed as limiting the scope of the present invention. All equivalent changes and modifications made in accordance with the scope of the patent and the contents of the specification should still fall within the scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating functional constipation in children with qi and yin deficiency, characterized in that: The traditional Chinese medicine raw materials in the aforementioned traditional Chinese medicine composition are in the following proportions by mass: 8-10 parts of Codonopsis pilosula; 8-10 parts of prepared Rehmannia root; 8-10 parts of Scrophularia ningpoensis; 8-10 parts of raw Rehmannia glutinosa; Ophiopogon japonicus 5-7 parts; Atractylodes macrocephala 8-10g; Citrus reticulata peel 5-7 parts; Cinnamomum cassia 2-4 parts; 5-7 parts of stir-fried immature bitter orange; 5-7 parts of hemp seed; 2-4 parts of licorice.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that: The traditional Chinese medicine raw materials in the aforementioned traditional Chinese medicine composition are in the following proportions by mass: Codonopsis pilosula 9 parts; Rehmannia glutinosa 9 parts; Scrophularia ningpoensis 9 parts; Nine portions of raw Rehmannia glutinosa; Ophiopogon japonicus 6 parts; Atractylodes macrocephala 9 parts; Citrus reticulata peel 6 parts; Cinnamomum cassia 3 parts; Stir-fried immature bitter orange (6 parts); hemp seed (6 parts); licorice root (3 parts).

3. The traditional Chinese medicine composition as described in claim 1, characterized in that: Each dose of the traditional Chinese medicine compound is equivalent to 64g-86g of raw materials.

4. Use of the traditional Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicine for treating constipation in children.

5. The use as described in claim 4, characterized in that, The constipation in children mentioned above is functional constipation in children.

6. The use as described in claim 5, characterized in that, The constipation in children described is functional constipation of the Qi and Yin deficiency type.

7. The use according to claim 4, characterized in that: The dosage forms of the traditional Chinese medicine composition include decoctions, pills, powders, tablets, ointments, granules, capsules, or oral liquids.

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