Clinical Trial for 'Shen Qu Xiao Shi' Oral Liquid in the... | NCT05030116

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

NCT05030116

Sponsor

Ruijin Hospital

Status

Completed

Last Update Posted

Sep 17, 2021Actual

Enrollment

356Actual

Phase

Phase 4

Conditions

Dyspepsia

Interventions

Shenqu Xiaoshi oral liquid
Domperidone suspension

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 26, 2019Actual

Primary Completion Date

May 10, 2020Actual

Completion Date

May 23, 2020Actual

First Submitted Date

Aug 30, 2021

First Submission Date that Met QC Criteria

Aug 30, 2021

First Posted Date

Sep 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2021

Last Update Posted Date

Sep 17, 2021Actual

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

356Actual

Label	Type	Description	Intervention Names
Experimental group	Experimental		Drug: Shenqu Xiaoshi oral liquid
Control Group	Active Comparator		Drug: Domperidone suspension

Name	Type	Description	Arm Group Labels	Other Names
Shenqu Xiaoshi oral liquid	Drug	Shenqu Xiaoshi oral liquid	Experimental group

Measure	Description	Time Frame
Total effective rate		Treatment for two weeks

Measure	Description	Time Frame
Clinical symptom scores		Treatment for one/two week(s)
Total effective rate		Two weeks after stopping the medication
Food intake

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms