Racecadotril granules for Acute Diarrhea in Children multicenter randomized controlled clinical trial

A multicenter, randomized, controlled Study to Evaluate the Efficacy and Safety of Racecadotril granules in children with Acute Diarrhea

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-12002199

Enrollment

Unknown

Registered

2012-05-24

Start date

2012-08-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Acute watery diarrhea

Interventions

Observation group:Racecadotril+Rehydration therapy

Control group:Rehydration therapy

Eligibility

Sex/Gender

Male

Age

No minimum to 3 Years

Inclusion criteria

Inclusion criteria: 1. Acute watery diarrhea,and duration of symptoms was less than 3 days,at least 3 times of watery stool in 24 hours; 2. Stool routine:WBC /HPF<5, RBC/HPF< 5, no pyocytes and phagocytes; 3. Age between 2 and 36 months; 4. Gender: Male; 5. Mild or moderate dehydration; 6. Parents (or Guardian) of children consent to participate in research.

Exclusion criteria

Exclusion criteria: 1. Stool routine :WBC /HPF>5, RBC/HPF> 5; 2. Drug allergy to Racecadotril; 3. A history of allergic disease; 4. With heart failure, liver impairment, renal impairment; 5. Children with mental nervous system diseases; 6. Children with severe dehydration; 7. A history of surgery within 30 days before the study; 8. Patients with frequent vomiting that cannot be medicated.

Design outcomes

Primary

Measure	Time frame
Outcome Assessment;Duration of symptoms and signs;Incidence of adverse reaction;	—

Countries

China

Contacts

Public ContactJie chen

hzcjie@zju.edu.cn+86 13858032920

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026