Anti-Secretory Drug in Treatment of Acute Watery Diarrhea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2018-08-31

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.

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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.

Conditions

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Acute Watery Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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children received ORS and racecadotril as treatment

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)

Group Type EXPERIMENTAL

Racecadotril

Intervention Type DRUG

racecadotril (dose of 1.5 mg/kg/day, an oral single daily dose for three days

children received ORS alone as treatment

25 children received ORS alone for treatment as a control group

Group Type ACTIVE_COMPARATOR

Racecadotril

Intervention Type DRUG

racecadotril (dose of 1.5 mg/kg/day, an oral single daily dose for three days

Interventions

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Racecadotril

racecadotril (dose of 1.5 mg/kg/day, an oral single daily dose for three days

Intervention Type DRUG

Other Intervention Names

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Acetorphan

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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No