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Clinical Trials/CTRI/2024/06/069214
CTRI/2024/06/069214Not yet recruitingPhase 2

Comparative effectiveness of individualised homoeopathic medicines in lm potencies and centesimal potencies for the management of irritable bowel syndrome: a prospective randomized clinical study

National Institute of Homoeopathy1 site in 1 country84 target enrollmentStarted: July 1, 2024Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Enrollment
84
Locations
1
Primary Endpoint
Assessment of increase or decrease in IBS-QOL questionnaire total score in patient

Study Overview

Brief Summary

The study will explore not only the symptomatic relief of IBS using IBS-QOL scores and IBS-SSS scores provided by the respective potencies of Homoeopathic medicine but also consider broader aspects such as quality of life, psychological well-being, and patient satisfaction. Through a comprehensive and randomized approach, this research seeks to enhance our understanding of homoeopathic approaches to IBS but also provide evidence-based guidance for practitioners in choosing between LM and centesimal potencies, thus optimizing individualized treatment strategies for patients suffering from this challenging condition.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

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

Inclusion Criteria

  • Patients suffering from IBS as per Rome IV diagnostic criteria b.
  • Both sexes c.
  • Age 18-65 years d.
  • Patients willing to participate in the study and giving written informed consent.
  • Ability to Understand Bengali or Hindi or English.

Exclusion Criteria

  • Any major gastrointestinal surgery in the last 6 months b.
  • Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or lifethreatening illness affecting the quality of life or any organ failure.
  • Currently receiving standard therapy for IBS and/ or homoeopathic treatment for any chronic condition(s) d.
  • Pregnant and lactating women e.
  • Self-reported immune compromised conditions f.
  • Substance abuse and/or dependence g.
  • Patients who are too sick for consultation.

Outcomes

Primary Outcomes

Assessment of increase or decrease in IBS-QOL questionnaire total score in patient

Time Frame: Baseline and every month up to 6 months of treatment.

suffering from Irritable Bowel Syndrome

Time Frame: Baseline and every month up to 6 months of treatment.

Secondary Outcomes

  • Assessment of increase or decrease in IBS-SSS questionnaire total score in patient(suffering from Irritable Bowel Syndrome)

Investigators

Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Subhrajit Paul

National Institute of Homoeopathy

Study Sites (1)

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