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Clinical trial for 'Shen Qu Xiao Shi' Oral liquid in the treatments of children's functional dyspepsiar

Comparison of shenqu xiaoshi oral liquid and doperidone suspension in the treatment of functional dyspepsia in children: a randomized, double-blind, double-simulated, multi-center clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022654
Enrollment
Unknown
Registered
2019-04-20
Start date
2019-05-31
Completion date
Unknown
Last updated
2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Dyspepsia

Interventions

Control Group:Doperidone suspension

Sponsors

Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 14 Years

Inclusion 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

Exclusion criteria: 1. Anorexia and dyspepsia caused by anorexia or dyspepsia caused by the influence of certain drugs or other confirmed diseases, such as acute and chronic gastroenteritis, peptic ulcer, history of gastrointestinal surgery, respiratory infection, acute and chronic hepatitis, anorexia nervosa, intestinal obstruction and other organic diseases; 2. Children with severe malnutrition; 3. Children with abnormal ecg, liver and kidney functions, nervous system, respiratory system, endocrine system and hematopoietic system; 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.

Design outcomes

Primary

MeasureTime frame
Total effective rate;

Secondary

MeasureTime frame
Clinical symptom scores;Total effective rate;Food intake;weight;Gastric emptying;The meal time;hemoglobin;

Countries

China

Contacts

Public ContactChundi Xu
chundixu55@163.com+86 18917762267

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 13, 2026