NCT06529497

Racecadotril Versus Standard Treatment in Decreasing the Duration of Acute Diarrhoea in Children

Efficacy of Racecadotril in Addition to Standard Treatment i in Decreasing the Duration of Acute Diarrhoea in Children as Compared to Standard of Treatment Alone

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Liaquat National Hospital & Medical College · Academic / Other
• Sex: All
• Age: 3 Months – 5 Years
• Healthy volunteers: Not accepted

Summary

Acute watery diarrhea is defined as the passage of 3 or more loose or liquid stools per day for 3 or more days but less than 14 days, including patients with mild to moderate dehydration per WHO classification. The study's outcome variables are stool frequency, measured by the total number of stools passed during 24 and 48 hours from the initiation of treatment, and hospital duration, measured by the total duration of hospital stay in hours. The null hypothesis states that racecadotril combined with standard treatment has no effect on reducing the mean number of stools passed during 48 hours compared to standard treatment alone in pediatric patients with acute watery diarrhea, while the alternate hypothesis suggests that racecadotril combined with standard treatment will significantly reduce the mean number of stools passed during 48 hours compared to standard treatment alone in these patients.

Conditions

• Diarrhoea

Interventions

Type	Name	Description
DRUG	Racecadotril	The intervention group will receive racecadotril+ORS+Zinc

Timeline

• Start date: 2024-08-02
• Primary completion: 2024-11-15
• Completion: 2024-12-02
• First posted: 2024-07-31
• Last updated: 2024-07-31