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

Shankaranarayanan Jeyakodi; Arunkanth Krishnakumar; Mohan Muttanahally Eraiah; Jestin V. Thomas; M. Mohamed Hussain

doi:10.18203/2319-2003.ijbcp20263697

Authors

Shankaranarayanan Jeyakodi Zeus Hygia Lifesciences Pvt. Ltd., Raviraja Industries, TIE, Balanagar, Hyderabad, Telangana, India
Arunkanth Krishnakumar Zeus Hygia Lifesciences Pvt. Ltd., Raviraja Industries, TIE, Balanagar, Hyderabad, Telangana, India
Mohan Muttanahally Eraiah Department of General Medicine, BGS Global Institute of Medical Sciences, BGS Health and Education City, Kengeri, Bangalore, Karnataka, India
Jestin V. Thomas Department of Clinical Research, Leads Clinical Research and Bio Services Pvt. Ltd., Bangalore, Karnataka, India
M. Mohamed Hussain Nisa Natural Healing, Dindigul, Tamil Nadu, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20263697

Keywords:

Aegle marmelos, Bael, Nutraceutical, Gut health, Inflammatory biomarkers

Abstract

Background: Recurrent upper gastrointestinal symptoms (GISs) such as postprandial fullness, early satiation, and epigastric discomfort often fulfil Rome IV criteria for functional dyspepsia. This randomised, double-blind, placebo-controlled trial evaluated the efficacy and tolerability of GEVALIN^TM, a standardised Aegle marmelos (bael) fruit extract, in adults with chronic upper GISs.

Methods: Eighty-four adults meeting Rome IV criteria were randomised 1:1 to GEVALIN^TM 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 GIS 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^TM 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. GIS 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^TM 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.

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