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Completed

NCT Number: NCT02642250

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

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.

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Key information

Conditions

Chronic Diarrhea

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Shifa Ul MUlk Memorial Hospital

Karachi, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Stool D/R

    Time frame: 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 outcomes

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

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Shifa Ul Mulk Memorial Hospital

Other

Registry information

Official study title

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

Acronym: HA

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 30, 2015
Registry last updated
Jan 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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