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

NCT06529497 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: R-30/RMU
• Study Type: interventional
• Target: 260
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diarrhoea

Keywords

Stool; Diarrhoea; Paediatrics

Outcome Measures

Primary Outcomes (1)

• Stool frequency

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

  48 hours

Secondary Outcomes (1)

• Hospital Duration

  48 Hours

Study Arms (2)

treatment group receiving (racecadotril+ORS+Zinc)

EXPERIMENTAL

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

Drug: Racecadotril

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

ACTIVE COMPARATOR

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

Drug: Racecadotril

Interventions

Racecadotril DRUG

The intervention group will receive racecadotril+ORS+Zinc

Also known as: ORS+Zinc

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

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• <!-- -->
• Parenteral Diarrhea
• Chronic Diarrhea like Coeliac disease, Lactose intolerance
• Mal-absorption Syndromes
• Diarrhea related to food poisoning, dysentery as suggested by history
• Severe dehydration patents who are vitally unstable.
• Diarrhea associated with measles.
• Persistent vomiting
• Abdominal distention
• Patients allergic to racecadotril
• Patients managed before enrolled to study

Sponsors & Collaborators

• Liaquat National Hospital & Medical College: lead

MeSH Terms

Conditions

Diarrhea

Interventions

racecadotril

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aqsa Jabeen Jabeen, MBBS

CONTACT

03327148228; aqsajabeen2010@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 31, 2024
• Study Start: August 2, 2024
• Primary Completion: November 15, 2024
• Study Completion: December 2, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share