A Phase 1/2 interventional study of Racecadotril in Diarrhoea, sponsored by Benazir Bhutto Hospital, Rawalpindi. Completed at 1 site in Pakistan. Open to participants aged 3 Months to 5 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Benazir Bhutto Hospital, Rawalpindi · Phase 1/2, Interventional, and Treatment
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.
877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.
This study's enrollment of 260 is above the median of 137 across 738 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →Benazir Bhutto Hospital, Rawalpindi is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Hospitalized Patients with acute watery diarrhea of both genders who are
Exclusion Criteria:
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The intervention group will receive racecadotril+ORS+Zinc while the reference group will receive ORS+Zinc alone
Drug: Racecadotril
The intervention group will receive racecadotril+ORS+Zinc while the reference group will receive ORS+Zinc alone
Drug: Racecadotril
The intervention group will receive racecadotril+ORS+Zinc
Also known as: ORS+Zinc
Stool frequency
Total no. of stools passed during 24 and 48 hours from initiation of treatment will be compared between two groups
Time frame: 48 hours
Hospital Duration
Total duration of hospital stay taken in hours
Time frame: 48 Hours
Plan to share: No
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Ran from Aug 2024 to primary completion in Nov 2024, 3 months.
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Racecadotril
Benazir Bhutto Hospital, Rawalpindi