Efficacy and Safety of Bacopa monnieri Extract for Stress Management and Sleep Quality: A Randomized, Double-Blind, Placebo-Controlled Trial

Background: Chronic psycho-social stress is associated with dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis, impaired sleep, and adverse mood outcomes.Bacopa monnieri is an established adaptogen with potential benefits on stress and cognitive-emotional functioning.This study evaluated the efficacy and safety of B-Lit Bacopa (BME), a Bio Enhanced B. monnieri extract, in adults experiencing non-chronic stress.Methods: In this randomized, double-blind, placebo-controlled clinical trial, 50 adults with non-chronic stress were assigned to receive BME (n=25) or placebo (n=25) once daily for 84 days.Validated psychometric assessments (Perceived Stress Scale-10 (PSS-10), Pittsburgh Sleep Quality Index (PSQI), Profile of Mood States (POMS), Beck Anxiety Inventory (BAI), wrist actigraphy (sleep latency, actual sleep time, sleep efficiency, wake episodes, wake after sleep onset (WASO)), and serum cortisol were measured at baseline and designated time points over 12 weeks.Safety was monitored through adverse events, vitals, physical examination, and laboratory analyses.Results: Forty-four subjects completed the study.BME produced significant improvements in perceived stress starting from baseline at Day 14 (-2.48 ± 2.76 vs -1.10 ± 1.38; p