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Completed

NCT Number: NCT05030116

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

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.

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Key information

Age range

3 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai Jiaotong University School of Medicine Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shenqu Xiaoshi Oral liquid

Drug

Shenqu Xiaoshi oral liquid

Domperidone suspension

Drug

Domperidone suspension

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

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

    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.

  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

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 1, 2021
Registry last updated
Sep 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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