A mixed-method research to develop diagnostic criteria for tubercular diathesis in homoeopathy and its use in a subsequent double-blind, randomized, placebo-controlled trial evaluating the efficacy of homoeopathic medicines in irritable bowel syndrome

Irritable bowel syndrome (IBS) (K 58.0 as per ICD 10) is a functional bowel disorder characterized by abdominal pain associated with altered bowel habits. Abdominal pain, discomfort, and changes in bowel habits without any structural or biochemical abnormalities are the hallmarks of the prevalent functional gastrointestinal illness known as irritable bowel syndrome or IBS. The overall stated prevalence in India varies between 4.2% and 14% depending on the region. It is one of the most important causes of absence from work, thereby causing a great economic burden. Homeopathy may have immense potential to offer in the successful treatment of Irritable Bowel Syndrome, but has remained seriously under-researched till date. Under such circumstances, we intend to undertake this research project to evaluate the efficacy and safety of homoeopathic medicines in the treatment Irritable Bowel Syndrome in adults. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 82 adults who are suffering from the Irritable Bowel Syndrome at the outpatient department of The Calcutta Homoeopathic Medical College and Hospital. Assessment will be done by Irritable Bowel Syndrome Quality of Life questionnaire (IBS-QOL) score [Primary outcome], IBS-SSS (Irritable Bowel Syndrome Symptoms Severity Score), and MYMOP2 ( Measure Yourself Medical Outcome Profile) score [Secondary outcomes], all to be measured every month, up to 3 months. Comparative analysis will be carried out to detect group differences. The result will be published in scientific journal.