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

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.

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Key information

Conditions

Diarrhoea Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

3 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Racecadotril

Drug

The intervention group will receive racecadotril+ORS+Zinc

Other names: ORS+Zinc

Primary outcomes

Stool frequency

Time frame: 48 hours

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

Secondary outcomes

Hospital Duration

Time frame: 48 Hours

Total duration of hospital stay taken in hours

Study contacts

Contact information is provided by the study sponsor or research team.

Aqsa Jabeen Jabeen, MBBS

CONTACT

[email protected]

03327148228

Sponsors and collaborators

Lead sponsor

Liaquat National Hospital & Medical College

Other

Registry information

Official study title

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

Acronym: ERADICATE

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jul 31, 2024
Registry last updated: Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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