Comparative Evaluation of Herbal and Allopathic Drugs for the Treatment of Chronic Diarrhea

Phase 2

Completed

• Conditions: Chronic Diarrhea
• Interventions: Drug: Entoban; Drug: Metronidazole

• Registration Number: NCT02642250
• Lead Sponsor: Shifa Ul Mulk Memorial Hospital

Brief Summary

Revival of significance and the emergent market of herbal medicinal products necessitate strong commitment by the stakeholders to safeguard the end users. The variability in the concentrations of constituents of plant material, coupled with the variety of extraction techniques and processing steps used by different manufacturers, results in distinct inconsistency in the quality of herbal products. The present study will be directed to a polyherbal formulation Entoban which integrates an outstanding blend of herbs that have been used for decades to eradicate microorganisms and worms from gastrointestinal tract. It is the combination of Holarrhena antidysenterica, Berberis aristata, Symplocos racemosa, Querecus infectoria and Helicteres isora. The current study would target the chemical assessment, pharmacological and comparative clinical evaluation of Entoban to assure its safety and efficacy.

Detailed Description

The study will be adopted to compare the efficacy, tolerability, and safety of Entoban using Metronidazole DS as a comparator. The study was carried out in XYZ hospital from Jan 2015 to Dec 2015. The participants will be selected on the basis of inclusion and exclusive criteria.

Study Timeline

• Study Start: 2015-01
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted: 2015-12-12
• Study First Submitted QC: 2015-12-23
• Study First Posted: 2015-12-30
• Last Update Submitted: 2015-12-30
• Last Update Posted: 2016-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Male or female adults between the age of 18-60 years who were suffering from diarrhea of presumed infectious origin and willing to participate were eligible for inclusion in the study.

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Exclusion Criteria

• Exclusion criteria were the presence of chronic
• Iatrogenic, or bloody diarrhea, having received antibiotic treatment for other medical or surgical problems
• Having a history of renal or hepatic dysfunction
• Having a concomitant infection.
• Patients receiving treatment with an anti-diarrheal drug in the five days prior to the study were also excluded.
• Pregnant or lactating women and women planning pregnancy were also ineligible for study participation.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Entoban Capsules	Entoban	Entoban is the combination of Holarrhena antidysenterica, Berberis aristata, Symplocos racemosa, Querecus infectoria and Helicteres isora.
Metronidazole DS	Metronidazole	Metronidazole DS(400 mg) is commonly used to treat diarrhea.It eliminates bacteria and other microorganisms that cause infections of the reproductive system, gastrointestinal tract, skin, vagina, and other areas of the body.

Primary Outcome Measures

Name	Time	Method
Stool D/R	5 days	The primary efficacy criterion will be the frequency and consistency of diarrhea in hours, from the first treatment dose to recovery. It will be evaluated through stool D/R. Stool D/R described the consistency, frequency and other important features of stool. Semisolid stool consistency with 1-2/day will be considered significant.

Secondary Outcome Measures

Name	Time	Method
Improvement in clinical symptoms such as abdominal pain, abdominal distension, etc will be secondary outcome measures	5 days

Trial Locations

Locations (1)

Shifa Ul MUlk Memorial Hospital; 🇵🇰 Karachi, Pakistan