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

Phase 1

Not yet recruiting

• Conditions: Diarrhoea
• Interventions: Drug: Racecadotril

• Registration Number: NCT06529497
• Lead Sponsor: Liaquat National Hospital & Medical College

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-26
• Study First Submitted QC: 2024-07-30
• Last Update Submitted: 2024-07-30
• Study First Posted: 2024-07-31
• Last Update Posted: 2024-07-31
• Study Start: 2024-08-02
• Primary Completion: 2024-11-15
• Study Completion: 2024-12-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• Hospitalized Patients with acute watery diarrhea of both genders who are

  1. Age: 03 months to 05 years
  2. Present in first 24 hours of onset of disease.

Exclusion Criteria

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1. Parenteral Diarrhea
2. Chronic Diarrhea like Coeliac disease, Lactose intolerance
3. Mal-absorption Syndromes
4. Diarrhea related to food poisoning, dysentery as suggested by history
5. Severe dehydration patents who are vitally unstable.
6. Diarrhea associated with measles.
7. Persistent vomiting
8. Abdominal distention
9. Patients allergic to racecadotril
10. Patients managed before enrolled to study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment group receiving (racecadotril+ORS+Zinc)	Racecadotril	The intervention group will receive racecadotril+ORS+Zinc while the reference group will receive ORS+Zinc alone
the control group (receiving ORS + Zinc or standard treatment)	Racecadotril	The intervention group will receive racecadotril+ORS+Zinc while the reference group will receive ORS+Zinc alone

Primary Outcome Measures

Name	Time	Method
Stool frequency	48 hours	Total no. of stools passed during 24 and 48 hours from initiation of treatment will be compared between two groups

Secondary Outcome Measures

Name	Time	Method
Hospital Duration	48 Hours	Total duration of hospital stay taken in hours