Clinical trial NCT05030116: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyspepsia
Keywords: functional dyspepsia
children
Traditional Chinese Medicine
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 356
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

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.

Primary outcomes:
measure: Total effective rate
timeFrame: Treatment for two weeks
Secondary outcomes:
measure: Clinical symptom scores
timeFrame: Treatment for one/two week(s)
measure: Total effective rate
timeFrame: Two weeks after stopping the medication
measure: Food intake
timeFrame: Treatment for one/two week(s) and two weeks after stopping the medication
measure: weight
timeFrame: Treatment for one/two week(s) and two weeks after stopping the medication
measure: The meal time
timeFrame: Treatment for one/two week(s) and two weeks after stopping the medication
measure: hemoglobin
timeFrame: Treatment for two weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiaotong University School of Medicine Ruijin Hospital
state: Shanghai
Study officials:
References: