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

Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05030116
• Other study ID #: SQXS20181221
• Status: Completed
• Phase: Phase 4
• Start date: June 26, 2019
• Est. completion date: May 23, 2020

Study information

• Verified date: August 2021
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: May 23, 2020
• Est. primary completion date: May 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyspepsia

Intervention

Drug:
• Shenqu Xiaoshi oral liquid
Shenqu Xiaoshi oral liquid
• Domperidone suspension
Domperidone suspension

Locations

Country	Name	City	State
China	Shanghai Jiaotong University School of Medicine Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total effective rate		Treatment for two weeks
Secondary	Clinical symptom scores		Treatment for one/two week(s)
Secondary	Total effective rate		Two weeks after stopping the medication
Secondary	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
Secondary	weight		Treatment for one/two week(s) and two weeks after stopping the medication
Secondary	The meal time		Treatment for one/two week(s) and two weeks after stopping the medication
Secondary	hemoglobin		Treatment for two weeks