Clinical trial NCT02642250: Comparative Evaluation of Herbal and Allopathic Drugs for the Treatment of Chronic Diarrhea
Official title: Chemical, Biological and Comparative Clinical Evaluation of Entoban to Determine Safety and Efficacy for the Treatment of Chronic Diarrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Diarrhea
Keywords: safety
efficacy
Lead sponsor: Shifa Ul Mulk Memorial Hospital
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Stool D/R
timeFrame: 5 days
Secondary outcomes:
measure: Improvement in clinical symptoms such as abdominal pain, abdominal distension, etc will be secondary outcome measures
timeFrame: 5 days
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Shifa Ul MUlk Memorial Hospital
Study officials:
affiliation: Hamdard University Karachi
name: Khan Usman Ghani, Ph. D
role: STUDY_DIRECTOR
References:
citation: Shakeel S, Usmanghani K, Asif HM. Efficacy and safety of Entoban for the treatment of chronic diarrhea. Pak J Pharm Sci. 2016 Nov;29(6 Suppl):2349-2353.