Herbal Medicine for Diarrhoea-Predominant IBS: A Randomised Controlled Clinical Study.

Irritable Bowel Syndrome with Diarrhoea (IBS-D) is a chronic functional gastrointestinal disorder involving altered gut motility, visceral hypersensitivity, gut–brain axis dysregulation, and microbiota imbalance. Conventional therapies often provide incomplete relief, necessitating multi-target therapeutic strategies. IBS-Sure Plus is a polyherbal formulation developed to address multiple pathophysiological pathways underlying IBS-D. This study evaluates the efficacy of IBS-Sure Plus compared with mesalamine and placebo in patients with IBS-D. In this prospective, randomised, three-arm, open-label, parallel-group study, 60 adults diagnosed with IBS-D (Rome IV criteria) were randomised (1:1:1) to receive IBS-Sure Plus, mesalamine, or placebo (n=20 per group) for 3 weeks. Primary outcomes included bowel movement frequency and stool consistency assessed using the Bristol Stool Scale (BSS). Secondary outcomes included complete spontaneous bowel movements (CSBM), symptom severity, effect size (ES), standardised response mean (SRM), and treatment satisfaction. Baseline characteristics were comparable across groups. IBS-Sure Plus demonstrated large to very large effect sizes (0.90–3.59) across symptom domains, exceeding mesalamine (0.65–2.31), while placebo showed negligible effects. SRM values indicated consistent responsiveness with IBS-Sure Plus (0.43–0.48). CSBM increased from 30% at baseline to 100% at Week 3 with IBS-Sure Plus, compared with 80% for mesalamine and 25% for placebo. Stool consistency normalised (BSS Types 3–4) predominantly in the IBS-Sure Plus group. Treatment satisfaction differed significantly among groups (p < 0.0001). IBS-Sure Plus demonstrated superior short-term efficacy compared with mesalamine and placebo, supporting its potential as a multi-target therapeutic option for IBS-D. Larger, blinded studies are warranted.

Trial registration number: CTRI/2022/04/041561 (Clinical Trial Registry of India) Date: April 1, 2022.