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

ConditionDiarrhoea
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age3-5
SponsorLiaquat National Hospital & Medical College

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Parenteral Diarrhea

Chronic Diarrhea like Coeliac disease, Lactose intolerance

Mal-absorption Syndromes

Diarrhea related to food poisoning, dysentery as suggested by history

Trial design

Design model

Parallel

Treatments tested in this trial

  • Racecadotril

    Drug

    The intervention group will receive racecadotril+ORS+Zinc

Treatment groups

260 Participants
are divided into 2 treatment groups
Group A: treatment group receiving (racecadotril+ORS+Zinc)Experimental treatment 1 intervention
Group B: the control group (receiving ORS + Zinc or standard treatment)Active comparator 1 intervention

Trial outcomes

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

Time frame
48 hours

Secondary outcomes

1

Hospital Duration

Total duration of hospital stay taken in hours

Time frame
48 Hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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