A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED COMPARATIVE STUDY EVALUATING THE EFFICACY OF OCITUMTM (HOLY BASIL LEAF EXTRACT) ON DEPRESSION, ANXIETY, STRESS, AND SLEEP QUALITY

*Nimish Dudhatra, Viraj Patel, Dr. Ghanshyam Patel, Dr. Sandeep Desai and Dr. Nile Desai

ABSTRACT

Background: Stress, anxiety, and sleep disturbances negatively affect mental health and quality of life. Ocitum™ (Holy Basil Leaf Extract) has been explored for its anti-stress and anxiolytic properties. This study evaluates its efficacy and safety in improving depression, anxiety, stress, and sleep quality. Methods: This double-blind, randomized, placebo-controlled study enrolled 61 participants experiencing mild to moderate depression, anxiety, stress, and sleep disturbances. Participants were randomized 1:1 to receive either Ocitum™ or a placebo for 8 weeks. The primary endpoints included changes in Depression, Anxiety, and Stress Scale (DASS-21) scores, Stanford Sleepiness Scale (SSS) scores and sleep parameters. Secondary endpoints assessed cortisol levels and WHOQOL-BREF scores. Safety assessments included complete blood count (CBC), ALT, and serum creatinine levels. Results: Significant improvements were observed in the Ocitum™ group for DASS-21 scores (−14.34 vs. 1.80; p < 0.001) and SSS scores (−1.33 vs. +0.20; p < 0.001). Sleep efficiency improved markedly in the Ocitum™ group compared to placebo for both workdays (8.24% vs. −0.44%) and free days (7.2% vs. −0.5%). Serum cortisol, ALT, and WHOQOL-BREF scores demonstrated statistically significant improvements in the Ocitum™ group. No adverse events or serious adverse events were reported. Conclusion: Ocitum™ significantly improved psychological well-being, sleep quality, and safety markers, offering a promising natural intervention for managing stress-related conditions.

Keywords: Mental Health, Depression, Anxiety, Stress, Ocimum tenuiflorum (Tulsi- Holy Basil), WHOQOL-BREF.