Back to resultsClinical Trial for 'Shen Qu Xiao Shi' Oral Liquid in the Treatments of Children's Functional Dyspepsia
Primary Purpose
Dyspepsia
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Shenqu Xiaoshi oral liquid
Domperidone suspension
Sponsored by
About this trial
This is an interventional treatment trial for Dyspepsia focused on measuring functional dyspepsia, children, Traditional Chinese Medicine
Eligibility Criteria
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.
Sites / Locations
- Shanghai Jiaotong University School of Medicine Ruijin Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group
Control Group
Arm Description
Outcomes
Primary Outcome Measures
Total effective rate
Secondary Outcome Measures
Clinical symptom scores
Total effective rate
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.
weight
The meal time
hemoglobin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05030116
Brief Title
Clinical Trial for 'Shen Qu Xiao Shi' Oral Liquid in the Treatments of Children's Functional Dyspepsia
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 26, 2019 (Actual)
Primary Completion Date
May 10, 2020 (Actual)
Study Completion Date
May 23, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia
Keywords
functional dyspepsia, children, Traditional Chinese Medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
356 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Shenqu Xiaoshi oral liquid
Intervention Description
Shenqu Xiaoshi oral liquid
Intervention Type
Drug
Intervention Name(s)
Domperidone suspension
Intervention Description
Domperidone suspension
Primary Outcome Measure Information:
Title
Total effective rate
Time Frame
Treatment for two weeks
Secondary Outcome Measure Information:
Title
Clinical symptom scores
Time Frame
Treatment for one/two week(s)
Title
Total effective rate
Time Frame
Two weeks after stopping the medication
Title
Food intake
Description
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.
Time Frame
Treatment for one/two week(s) and two weeks after stopping the medication
Title
weight
Time Frame
Treatment for one/two week(s) and two weeks after stopping the medication
Title
The meal time
Time Frame
Treatment for one/two week(s) and two weeks after stopping the medication
Title
hemoglobin
Time Frame
Treatment for two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Shanghai Jiaotong University School of Medicine Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Trial for 'Shen Qu Xiao Shi' Oral Liquid in the Treatments of Children's Functional Dyspepsia
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