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CompletedNCT05030116Updated Sep 17, 2021

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

A Phase 4 interventional study of Shenqu Xiaoshi oral liquid and Domperidone suspension in Dyspepsia, sponsored by Ruijin Hospital. Completed at 1 site in China. Open to participants aged 3 Years to 14 Years. Per ClinicalTrials.gov, last updated 2021-09-17.

Sponsored by Ruijin Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Jun 2019, registered Aug 2021).
Phase
Phase 4
Study type
Interventional
Enrollment
356
Allocation
Randomized
Ages
3 Years to 14 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Dyspepsia

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Keywords

  • functional dyspepsia
  • children
  • Traditional Chinese Medicine
03

In context

Dyspepsia

363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.

This study's enrollment of 356 is above the median of 87 across 297 interventional studies indexed under Dyspepsia.

Browse Dyspepsia studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
356 participants (actual)

Study arms

  • Experimental
    Experimental group

    Drug: Shenqu Xiaoshi oral liquid

  • Active comparator
    Control Group

    Drug: Domperidone suspension

Interventions

  • DrugShenqu Xiaoshi oral liquid

    Shenqu Xiaoshi oral liquid

  • DrugDomperidone suspension

    Domperidone suspension

06

What researchers measure

Primary outcomes

  1. Total effective rate

    Time frame: Treatment for two weeks

Secondary outcomes

  1. Clinical symptom scores

    Time frame: Treatment for one/two week(s)

  2. Total effective rate

    Time frame: Two weeks after stopping the medication

  3. 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.

    Time frame: Treatment for one/two week(s) and two weeks after stopping the medication

  4. weight

    Time frame: Treatment for one/two week(s) and two weeks after stopping the medication

  5. The meal time

    Time frame: Treatment for one/two week(s) and two weeks after stopping the medication

  6. hemoglobin

    Time frame: Treatment for two weeks

07

Study locations

1 site
  • Shanghai Jiaotong University School of Medicine Ruijin Hospital
    Shanghai, Shanghai 200025, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05030116
Lead sponsor
Ruijin Hospital
Responsible party
Sponsor
First posted
Sep 1, 2021
Start date
Jun 26, 2019
Primary completion
May 10, 2020
Completion
May 23, 2020
Last update
Sep 17, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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