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

NCT02642250 | Completed Phase 2 DMC

• 1 other identifier: Entb-1117
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Diarrhea

Keywords

safety; efficacy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Improvement in clinical symptoms such as abdominal pain, abdominal distension, etc will be secondary outcome measures

  5 days

Study Arms (2)

Entoban Capsules

EXPERIMENTAL

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

Drug: Entoban

Metronidazole DS

EXPERIMENTAL

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.

Drug: Metronidazole

Interventions

Metronidazole 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.

Metronidazole DS

Entoban 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.

Entoban Capsules

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shifa Ul Mulk Memorial Hospital: lead

Study Sites (1)

Shifa Ul MUlk Memorial Hospital

Karachi, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 28167477 DERIVED

MeSH Terms

Interventions

Metronidazole; Entoban

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Khan Usman Ghani, Ph. D

  Hamdard University Karachi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sadia Shakeel

Study Record Dates

• First Submitted: December 12, 2015
• First Posted: December 30, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 1, 2016

Record last verified: 2015-12

Locations

PA (1)