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

Liaquat National Hospital & Medical College

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Diarrhoea

Treatments: Drug: Racecadotril

Study type: Interventional

Funder types: Other

Identifiers

NCT06529497

R-30/RMU

Details and patient eligibility

About

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.

Enrollment: 260 estimated patients

Sex: All

Ages: 3 months to 5 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

treatment group receiving (racecadotril+ORS+Zinc)

Experimental group

Description:

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

Treatment:

Drug: Racecadotril

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

Active Comparator group

Description:

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

Treatment:

Drug: Racecadotril