A community based clinical trial to study the effects of Racecadotril and standard care versus standard care alone in children below 5 years of age with diarrhoea

Community-based randomized control trial of racecadotril in gastroenteritis in children less than 5 years of age

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2007/091/000001

Enrollment

128

Registered

2007-08-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Acute gastroenteritis in children

Interventions

Intervention1: Racecadotril oral: 1.5 mg/kg for 3 days Control Intervention1: Standard care: Oral rehydration solution, etc., for 3 days

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion:Child 4-59 months, with acute watery diarrhoea

Exclusion criteria

Exclusion criteria: Child <4 months or >60 months, not resident in Kasba/ Ramanaickanpalayam, bloody diarrhoea, diarrhoea requiring intravenous rehydration, diarrhoea >1 week duration, not willing for enrollment

Design outcomes

Primary

Measure	Time frame
Duration of diarrhoea (time to first formed stool)Timepoint: within first week or till time to first formed stool	—

Secondary

Measure	Time frame
1. Severity of diarrhoea 2. Requirement for rehydrationTimepoint: Days 1, 2 and 3 of follow-up	—

Countries

India

Contacts

Public ContactGagandeep Kang

Christian Medical College

gkang@cmcvellore.ac.in0416-2282052

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026