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Racecadotril For The Treatment Of Acute Watery Diarrhoea In Children. A Randomised Double Blinded Placebo Controlled Trial

Racecadotril For The Treatment Of Acute Watery Diarrhoea In Children Admitted to the Kenyatta national Hopital. A Randomised Double Blinded Placebo Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR201403000694398
Enrollment
120
Registered
2013-11-02
Start date
2014-02-05
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Digestive System Paediatrics Acute Gastroenteritis

Interventions

Racecadotril +standard WHO treatment ( ORS, Zinc, continued feeding)
Placebo + Standard WHO treatment ( ORS, Zinc, Continued feeding)

Sponsors

Aga Khan University
Lead Sponsor
Sai Pharmaceuticals
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Children 3mo ¿ 60mo Acute gastroenteritis as defined by WHO (the passage of unusually loose or watery stools, usually at least three times in a 24 hour period) requiring admission for severe gastroenteritis (as evidenced by a vesicari score of >11) parental consent obtained

Exclusion criteria

Exclusion criteria: Scoring 3 on the vesicari score for Maximum Number Vomiting Episodes per Day Clinical diagnosis of dysentery Requiring / having been prescribed antibiotics and/or probiotics or any other anti-diarrhoeal medication for the disease (except zinc) known diagnosis of liver and renal failure

Design outcomes

Primary

MeasureTime frame
severity of the diarrhoeal illness, measured by the number of stools in the first 48 hours after introduction of the drug and the consistency of stools at 48 hours

Secondary

MeasureTime frame
the duration of inpatient stay ;number of adverse events associated with racecadotril

Countries

Kenya

Contacts

Public ContactJaspreet Singh Gharial

3rd year postgraduate resident

jaspreet.singh@aku.edu+254 722 690 453

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026