About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Hospitalized Patients with acute watery diarrhea of both genders who are
Age: 03 months to 05 years
Present in first 24 hours of onset of disease.
Disqualifiers
Parenteral Diarrhea
Chronic Diarrhea like Coeliac disease, Lactose intolerance
Mal-absorption Syndromes
Diarrhea related to food poisoning, dysentery as suggested by history
Trial design
Parallel
Treatments tested in this trial
Racecadotril
DrugThe intervention group will receive racecadotril+ORS+Zinc
Treatment groups
Trial outcomes
Primary outcomes
Stool frequency
Total no. of stools passed during 24 and 48 hours from initiation of treatment will be compared between two groups
Secondary outcomes
Hospital Duration
Total duration of hospital stay taken in hours
Locations
Sponsors and contacts
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