Clinical Trial

Safety and Efficacy of Racecadotril in Children With Acute Watery Diarrhea

Completed
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Summary
Acute watery diarrhea is a common cause of illness and hospitalization in children under five years of age, particularly in developing countries. The mainstay of treatment is oral rehydration therapy, which prevents dehydration but does not reduce stool frequency or duration of diarrhea. Persistent diarrhea often leads to repeated hospital visits and increased healthcare burden. This randomized controlled trial was conducted to evaluate the safety and efficacy of racecadotril as an adjunct to standard oral rehydration therapy in children aged 3 months to 5 years hospitalized with acute watery diarrhea. Participants were randomly assigned to receive either racecadotril in addition to standard therapy or placebo with standard therapy. The primary outcomes assessed were reduction in stool frequency and improvement in stool consistency, along with duration of hospital stay. The study aimed to determine whether racecadotril provides additional clinical benefit when used alongside standard treatment in pediatric acute watery diarrhe
Trial Details
NCT Number NCT07392931
Lead Sponsor Punjab Rangers Teaching Hospital Lahore
Conditions Acute Watery Diarrhea
Enrollment 200 participants
Start Date 2025-06-01
Primary Completion 2025-11-30 (estimated)
Study Completion 2025-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-06