Anti-Secretory Drug in Treatment of Acute Watery Diarrhea

Study Overview
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Brief Summary
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In conclusion, racecadotril is an anti-secretory drug that exerts its antidiarrheal effect by inhibiting intestinal enkephalinase. It is effective in reducing the volume and frequency of stool output. racecadotril is well tolerated and safe by providing symptomatic relief and reducing the severity of diarrhea as an adjuvant therapy during the acute attack of gastroenteritis. It is recommended that the new generations of already discovered drugs for control of secretory diarrhea should be studied to discover the ones with fewer side effects to other systems in the body.

Detailed Description
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Background: Previous studies have shown that racecadotril is a safe and effective drug in treating children with acute diarrhea. Study Aim: to evaluate the effect of racecadotril as an adjunct to oral rehydration solution in the treatment of acute watery diarrhea among children under 5 years of age. Subjects and methods: This RCT trial included 50 children with acute watery diarrhea for 5 days or less with a frequency of three or more diarrheic stools in the past 24 hours before admission to the hospital, with no/mild to moderate dehydration.

Official Title
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Role of Anti-Secretory Drug in Treatment of Children With Acute Watery Diarrhea

Conditions
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Acute Watery Diarrhea

Intervention / Treatment
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* Drug: Racecadotril


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age group for six months - 5 years. No or mild to moderate dehydration. Alert patient (to tolerate oral intake since the drug is only available in oral form). Exclusion Criteria: Patients with severe dehydration (inability to drink because of drowsiness). Patients with any serious concomitant illness that needs antibiotic treatment. If severe adverse events occur at any time. Chronic diarrhea.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: children received ORS and racecadotril as treatment<br>25 children received ORS and racecadotril as treatment (at a dose of 1.5 mg/kg/day, an oral single daily dose for three days) | Drug: Racecadotril<br>* racecadotril (dose of 1.5 mg/kg/day, an oral single daily dose for three days<br>* Other names: Acetorphan;|
| Active Comparator: children received ORS alone as treatment<br>25 children received ORS alone for treatment as a control group | Drug: Racecadotril<br>* racecadotril (dose of 1.5 mg/kg/day, an oral single daily dose for three days<br>* Other names: Acetorphan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diarrheal episode | number | 1-3 months |