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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-02

Study Completion Date

2024-12-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Diarrhoea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment group receiving (racecadotril+ORS+Zinc)

The intervention group will receive racecadotril+ORS+Zinc while the reference group will receive ORS+Zinc alone

Group Type EXPERIMENTAL

Racecadotril

Intervention Type DRUG

The intervention group will receive racecadotril+ORS+Zinc

the control group (receiving ORS + Zinc or standard treatment)

The intervention group will receive racecadotril+ORS+Zinc while the reference group will receive ORS+Zinc alone

Group Type ACTIVE_COMPARATOR

Racecadotril

Intervention Type DRUG

The intervention group will receive racecadotril+ORS+Zinc

Interventions

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Racecadotril

The intervention group will receive racecadotril+ORS+Zinc

Intervention Type DRUG

Other Intervention Names

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ORS+Zinc

Eligibility Criteria

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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

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

Minimum Eligible Age

3 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No