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

Chronic Diarrhea Clinical Trial

— HA  

Official title:

Chemical, Biological and Comparative Clinical Evaluation of Entoban to Determine Safety and Efficacy for the Treatment of Chronic Diarrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02642250
• Other study ID #: Entb-1117
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 12, 2015
• Last updated: December 30, 2015
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Shifa Ul Mulk Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Diarrhea
• Diarrhea

Intervention

Drug:
• Metronidazole
The data will be recorded for physical examination including gender , age, height, weight, temperature, heart rate ,respiratory rate and blood pressure of the subject, number of stool per day, stool with or without mucus or mixed with blood along with abdominal cramps, dehydration, nausea, vomiting and related clinical information will be carefully recorded. Statistical tools and tabulated results will be used to identify the similarities and differences in safety, efficacy and tolerability of treatment.
• Entoban
To evaluate the safety and efficacy of coded herbal formulation (Entoban) through randomized clinical study and compared with Metronidazole DS for treatment of gastrointestinal infections for improving the health of the community with due regard to the prevalence of disease and the feasibility of using alternative treatments.

Locations

Country	Name	City	State
Pakistan	Shifa Ul MUlk Memorial Hospital	Karachi

Sponsors (1)

Lead Sponsor	Collaborator
Shifa Ul Mulk Memorial Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool D/R	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.	5 days	Yes
Secondary	Improvement in clinical symptoms such as abdominal pain, abdominal distension, etc will be secondary outcome measures		5 days	Yes