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

NCT ID: NCT02642250

Last Updated: 2016-01-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-12-31

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.

Conditions

Chronic Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Entoban Capsules

Entoban is the combination of Holarrhena antidysenterica, Berberis aristata, Symplocos racemosa, Querecus infectoria and Helicteres isora.

Group Type: EXPERIMENTAL

Entoban

Intervention Type: DRUG

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.

Metronidazole DS

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.

Group Type: EXPERIMENTAL

Metronidazole

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shifa Ul Mulk Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hafiz Muhammad Asif

Sadia Shakeel

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khan Usman Ghani, Ph. D

Role: STUDY_DIRECTOR

Hamdard University Karachi

Locations

Shifa Ul MUlk Memorial Hospital

Karachi, , Pakistan

Countries

Pakistan

References

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.

Reference Type: DERIVED

PMID: 28167477 (View on PubMed)

Other Identifiers

Entb-1117

Identifier Type: -

Identifier Source: org_study_id