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

Phase 4

Completed

• Conditions: Dyspepsia
• Interventions: Drug: Shenqu Xiaoshi oral liquid; Drug: Domperidone suspension

• Registration Number: NCT05030116
• Lead Sponsor: Ruijin Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-26
• Primary Completion: 2020-05-10
• Study Completion: 2020-05-23
• Status Verified: 2021-08
• Study First Submitted: 2021-08-30
• Study First Submitted QC: 2021-08-30
• Study First Posted: 2021-09-01
• Last Update Submitted: 2021-09-14
• Last Update Posted: 2021-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 356

Inclusion Criteria

1. Children aged 3-14 years, regardless of gender;
2. 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;
3. Have symptoms at least 2 months before diagnosis and at least 4 days per month;
4. 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.
5. 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

1. 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;
2. Children with severe malnutrition;
3. Children with abnormal ecg, liver and kidney functions, nervous system, respiratory system and endocrine system considered by the investigator;
4. Children with mental disorders, dementia and unclear speech;
5. Lactose intolerance or allergy to drug ingredients, or allergy to traditional Chinese medicine;
6. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Shenqu Xiaoshi oral liquid	-
Control Group	Domperidone suspension	-

Primary Outcome Measures

Name	Time	Method
Total effective rate	Treatment for two weeks

Secondary Outcome Measures

Name	Time	Method
Clinical symptom scores	Treatment for one/two week(s)
Total effective rate	Two weeks after stopping the medication
Food intake	Treatment for one/two week(s) and two weeks after stopping the medication	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.
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

Trial Locations

Locations (1)

Shanghai Jiaotong University School of Medicine Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China