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

NCT06529497 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2024-07-31

No results posted yet for this study

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

DRUG

Racecadotril

The intervention group will receive racecadotril+ORS+Zinc

Sponsors & Collaborators

  • Liaquat National Hospital & Medical College

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-02
Primary Completion
2024-11-15
Completion
2024-12-02

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06529497 on ClinicalTrials.gov