Publication:

Gevalin™ Aegle marmelos fruit extract improves gastrointestinal symptoms, quality of life, and inflammatory markers in symptomatic adults: a randomized, double-blind and placebo-controlled trial

Background This is randomised, double-blind, placebo-controlled trial evaluated the efficacy and tolerability of Gevalin™, a standardised Aegle marmelos (bael) fruit extract, in adults with chronic upper gastrointestinal symptoms such as postprandial fullness, early satiation, bloating, acidity, and epigastric discomfort etc.

Methods Eighty-four adults meeting Rome IV criteria were randomised 1:1 to Gevalin™ 250 mg (n=42) or placebo (n=42) once daily for 56 days. The primary endpoint was change in GIS Rating Scale (GSRS) total score from baseline to Day 56. Secondary outcomes were gastrointestinal symptom and Functional Dyspepsia Related Quality of Life (FDQoL) total scores; inflammatory and oxidative stress biomarkers were exploratory. Analysis was per protocol (n=40 vs. 38).

Results Gevalin™ significantly reduced GSRS total score versus placebo (change -3.87±4.03 vs. -0.55±1.19; difference -3.32, 95% CI -4.66 to -1.98; p<0.0001), a 20.2% vs. 2.7% reduction. Gastrointestinal symptom total score improved significantly (-7.30±5.25 vs. +0.29±2.73; p<0.0001), as did all four FDQoL domains (p≤0.0083). Exploratory analyses showed greater reductions in erythrocyte sedimentation rate (p<0.0001), C-reactive protein (p=0.0119), and 8-hydroxy-2′-deoxyguanosine (p=0.0076), and improved sleep quality (p<0.0001). No serious or treatment-related adverse events (AEs) were reported.

Conclusions Gevalin™ significantly improved GISs, quality of life, sleep quality, and selected exploratory biomarkers over 56 days, with favorable short-term tolerability, and warrants confirmation in multicentre trials with long-term follow-up.