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Clinical Trials/CTRI/2017/05/008480
CTRI/2017/05/008480CompletedPhase 2

An open-label randomized clinical study for the comparative effectiveness of constitutional homoeopathic medicine with Dysentery Compound in cases of Irritable Bowel Syndrome

National Institute of Homoeopathy Ministry of AYUSH Govt of India1 site in 1 country60 target enrollmentStarted: May 15, 2017Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
IBS Quality of Life (IBS-QOL) questionnaire

Study Overview

Brief Summary

Irritable bowel syndrome (IBS) is the most common gastrointestinal disorder worldwide characterized by recurrent abdominal pain, bloating, altered bowel function (constipation, diarrhoea, or both), and a myriad of gastrointestinal symptoms. Its prevalence ranges between 10-15% in Western countries, 6.5-10.1% in Asian countries, and around 4% in North India, where it poses a significant burden on the rural adults and reduces the quality of life. Severe IBS can significantly reduce quality of life, disrupt activities of daily life, and result in exorbitant healthcare costs. In the absence of a reliable biologic marker of IBS, it has been challenging to develop well-targeted, effective IBS drugs and optimal endpoints for clinical trials. Due to unsatisfactory results from conventional treatment of IBS, Complementary and Alternative Medicine (CAM) modalities are increasingly becoming popular treatment alternatives. Unfortunately, most of the CAM clinical trials, including that of homoeopathy, have been of poor quality, and the efficacy of these therapies have not been adequately elucidated. In this project, we intend to evaluate the comparative efficacy of individualized homoeopathic treatment and treatment with a specific medicine Dysentery Compound in 60 patients suffering from IBS using IBS quality of life questionnaire over 3 months at the National Institute of Homoeopathy, Kolkata, West Bengal, India from May 2017 onward. It is an open, prospective, randomized, parallel arm trial. The generated results will undergo statistical analysis and will be published in scientific journal.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Open Label

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Age 18 to 65 years
  • Both sexes
  • Symptomatic IBS for at least 2 days/week over 3 months
  • IBS diagnosed and sub-typed as per Rome III criteria.

Exclusion Criteria

  • Patients who are too sick for consultation
  • Unable to read patient information sheets and/or not giving consent to join the study
  • Diagnosed cases of unstable mental or psychiatric illness or other systemic disease affecting quality of life
  • Major gastro-intestinal surgery in last 6 months
  • Currently receiving standard therapy for IBS and/or undergoing homoeopathic treatment for chronic condition(s)
  • Pregnant and lactating women
  • Self-reported immune-compromised state
  • Substance abuse and/or dependence.

Outcomes

Primary Outcomes

IBS Quality of Life (IBS-QOL) questionnaire

Time Frame: 3 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
National Institute of Homoeopathy Ministry of AYUSH Govt of India
Sponsor Class
Government medical college

Study Sites (1)

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