NCT05030116

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
356

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2020

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
Last Updated

September 17, 2021

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

August 30, 2021

Last Update Submit

September 14, 2021

Conditions

Dyspepsia

Keywords

functional dyspepsiachildrenTraditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

  • Total effective rate

    Treatment for two weeks

Secondary Outcomes (6)

  • 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

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL
Drug: Shenqu Xiaoshi oral liquid

Control Group

ACTIVE COMPARATOR
Drug: Domperidone suspension

Interventions

Shenqu Xiaoshi oral liquidDRUG

Shenqu Xiaoshi oral liquid

Experimental group
Domperidone suspensionDRUG

Domperidone suspension

Control Group

Eligibility Criteria

Age3 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Jiaotong University School of Medicine Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2021

First Posted

September 1, 2021

Study Start

June 26, 2019

Primary Completion

May 10, 2020

Study Completion

May 23, 2020

Last Updated

September 17, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)