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

Efficacy of Racecadotril in Addition to Standard Treatment i in Decreasing the Duration of Acute Diarrhoea in Children as Compared to Standard of Treatment Alone

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06529497
Acronym
ERADICATE
Enrollment
260
Registered
2024-07-31
Start date
2024-08-02
Completion date
2024-12-02
Last updated
2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhoea

Keywords

Stool, Diarrhoea, Paediatrics

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.

Interventions

The intervention group will receive racecadotril+ORS+Zinc

Sponsors

Liaquat National Hospital & Medical College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Months to 5 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Stool frequency48 hoursTotal no. of stools passed during 24 and 48 hours from initiation of treatment will be compared between two groups

Secondary

MeasureTime frameDescription
Hospital Duration48 HoursTotal duration of hospital stay taken in hours

Contacts

Primary ContactAqsa Jabeen Jabeen, MBBS
aqsajabeen2010@gmail.com03327148228

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026