Bowel disorder and its homoeopathic treatment

Phase 2

Completed

Conditions: Irritable Bowel Syndrome

Registration Number: CTRI/2017/05/008480

Lead Sponsor: National Institute of Homoeopathy Ministry of AYUSH Govt of India

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

Age 18 to 65 years 2.
Both sexes 3.
Symptomatic IBS for at least 2 days/week over 3 months 4.
IBS diagnosed and sub-typed as per Rome III criteria.

Exclusion Criteria

Patients who are too sick for consultation 2.
Unable to read patient information sheets and/or not giving consent to join the study 3.
Diagnosed cases of unstable mental or psychiatric illness or other systemic disease affecting quality of life 4.
Major gastro-intestinal surgery in last 6 months 5.
Currently receiving standard therapy for IBS and/or undergoing homoeopathic treatment for chronic condition(s) 6.
Pregnant and lactating women 7.
Self-reported immune-compromised state 8.
Substance abuse and/or dependence.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IBS Quality of Life (IBS-QOL) questionnaire	3 months

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): National Institute of Homoeopathy, Govt. of India
🇮🇳
Kolkata, WEST BENGAL, India
National Institute of Homoeopathy, Govt. of India
🇮🇳Kolkata, WEST BENGAL, India
Laijun Nahar
Principal investigator
7980274752
laijun786@gmail.com