Homeopathic medicines for problems related to recurrent stool

Phase 2/3

Recruiting

Conditions: Irritable bowel syndrome with diarrhea,

Registration Number: CTRI/2019/11/021916

Lead Sponsor: National Institute of Homoeopathy

Brief Summary: Irritable Bowel Syndrome (IBS) is one of the most frequently encountered gastro-intestinal disorders globally, distressing 10-20% of the adult population. The prevalence is 6-22% in the Western countries, although it is likely to be lower and ranges from 2-17% in the Eastern countries. The prevalence of IBS in North Indian people is around 4% where it poses a considerable burden on the rural adults. Early studies from Asia reported a prevalence of

IBS below 5%. IBS is characterized by recurrent pain abdomen, distension, altered bowel movement (constipation, diarrhea, or both), and a multitude of gastrointestinal complaints. Severe IBS can significantly alter quality of life, disrupt daily activities, and result in inflated healthcare costs. Homeopathy research evidences in IBS remain compromised. We aimed to evaluate its efficacy beyond mere placebo effect in blinded and randomized design

by using validated outcome measures. In this open-label, randomized, placebo-controlled, three parallel arms, clinical trial, 111 eligible patients suffering from IBS will be randomized to receive either homeopathic medicine Gambogia (n=37) in centesimal potencies, or individualized homeopathic medicines in centesimal potencies (n=37), or identical looking placebo (n=37). The patients will be advised to avoid foods which trigger the disease condition like fat diet, cabbage, beans and legumes, to consume fibre rich diet, sour curd and sufficient fluid daily, and to practice yoga, meditation, and exercises daily. Duration of therapy will be 3 months. IBS-QOL questionnaire, IBS Symptoms Severity Score, and EQ-5D-5L questionnaire score and VAS measures will be assessed at baseline, and every month up to 3 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 111

Inclusion Criteria

a) Patients suffering from IBS, as per Rome IV diagnostic criteria b) Both sexes c) Age 18-65 years d) Literate patients with ability to read Bengali and/or English e)Patients willing to participate in the study and giving written informed consent.

Exclusion Criteria

a) Patients who are too unwell to take part b) Inability to read patient information sheets and/or denied consent to take part c) Diagnosed cases of unstable psychiatric complaints or other systemic diseases affecting quality of life d) Any major gastro-intestinal surgery in last 6 months e) Currently receiving standard therapy for IBS and/or homeopathic treatment for any chronic condition(s) f) Pregnant and lactating women g) Self-reported immune compromised conditions h) Substance abuse and/or dependence.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IBS Quality of Life questionnaire	Baseline, every month, up to 3 months

Secondary Outcome Measures

Name	Time	Method
IBS symptom severity score	Baseline, every month, up to 3 months
EQ-5D-5L questionnaire score and VAS measure	Baseline, every month, up to 3 months

Trial Locations

Locations (1): National Institute of Homoeopathy
🇮🇳
Kolkata, WEST BENGAL, India
National Institute of Homoeopathy
🇮🇳Kolkata, WEST BENGAL, India
Sourav Das
Principal investigator
8346808824
souravnih@gmail.com