Clinical Trial for 'Shen Qu Xiao Shi' Oral Liquid in the Treatments of Children's Functional Dyspepsia

Study Overview
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Brief Summary
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With domperidone suspension as the control, the effect of shenqu xiaoshi oral liquid on functional dyspepsia in children was evaluated objectively through multi-center, randomized, double-blind and double-simulation experiment, which alleviated the clinical symptoms, restored and promoted the normal growth and development of children.

Official Title
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Comparison of Shenqu Xiaoshi Oral Liquid and Domperidone Suspension in the Treatment of Functional Dyspepsia in Children: a Randomized, Double-blind, Double-simulated, Multi-center Clinical Study

Conditions
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Dyspepsia

Intervention / Treatment
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* Drug: Shenqu Xiaoshi oral liquid
* Drug: Domperidone suspension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 3-14 years, regardless of gender; Meet 1 or more conditions: (1) full after dinner; (2) early full; (3) abdominal pain, and defecation has nothing to do; After appropriate evaluation, symptoms cannot be fully explained by other diseases; Or have other symptoms of dyspepsia, but not caused by other diseases; Have symptoms at least 2 months before diagnosis and at least 4 days per month; During the 2-week leading-in period, no drugs were used to treat infantile anorexia and functional dyspepsia, and good eating habits were established. The patients were fed on time and still had the above-mentioned symptoms of anorexia and functional dyspepsia; The symptom score was 3. The legal guardian of the child should sign the informed consent form. If the child is 10 years old or older, they should sign the informed consent form and agree to participate in the study. Exclusion Criteria: Anorexia and dyspepsia caused by anorexia or dyspepsia caused by the influence of certain drugs or other confirmed diseases, such as erosive gastritis and gastric ulcer; Children with severe malnutrition; Children with abnormal ecg, liver and kidney functions, nervous system, respiratory system and endocrine system considered by the investigator; Children with mental disorders, dementia and unclear speech; Lactose intolerance or allergy to drug ingredients, or allergy to traditional Chinese medicine; Children who have participated in other clinical trials or are participating in clinical trials of other drugs within 12 weeks; According to the judgment of the researchers, there are other diseases or conditions that reduce the possibility of enrollment or complicate enrollment, such as unstable living environment and inconvenient transportation, which are easy to cause loss and follow-up.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br> | Drug: Shenqu Xiaoshi oral liquid<br>* Shenqu Xiaoshi oral liquid<br>|
| Active Comparator: Control Group<br> | Drug: Domperidone suspension<br>* Domperidone suspension<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total effective rate |  | Treatment for two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical symptom scores |  | Treatment for one/two week(s) | 
| Total effective rate |  | Two weeks after stopping the medication | 
| Food intake | Food intake was measured by a scale filling by subjects or their parents. Scores range from 0 to 3. Higher score represents greater reduction in food intake and 0 means unchanged. | Treatment for one/two week(s) and two weeks after stopping the medication | 
| weight |  | Treatment for one/two week(s) and two weeks after stopping the medication | 
| The meal time |  | Treatment for one/two week(s) and two weeks after stopping the medication | 
| hemoglobin |  | Treatment for two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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functional dyspepsia, children, Traditional Chinese Medicine