A Randomized,Double-blind, Placebo-controlled, Multi-centric, Interventional, Prospective Clinical Study to Evaluate Efficacy and Safety of Passiflora incarnata (Aerial Parts) Extract in participants with Stress and Insomnia

Abstract

Abstract Background: Passiflora incarnata is used for treating anxiety or nervousness, generalized anxiety disorder (GAD), insomnia, and other related disorders. Previous studies indicate that passion flower has a positive effect on sleep patterns. It reduces the time to fall asleep and increases the duration of sleep. Objectives: To Evaluate Efficacy and Safety of Passiflora incarnata (Passion Flower) Extract in participants with Stress and Insomnia Methods: In a Randomized, Double Blind, Placebo Controlled, Multi-centre, Interventional, Prospective Clinical Study, a total of 65 participants with stress and insomnia were screened and recruited and randomised to two groups (32 in the Passiflora group and 33 in the Placebo group). The participants were randomized either to Passiflora incarnata (Aerial Parts) Extract group or placebo group in 1:1 ratio. Subjects were asked to take given product at bed time with water for 30 days. Subjects were evaluated on Day 1, Day 15 and Day 30 on Perceived Stress Scale (PSS), subject’s Quality of Life on GHQ12 Scale. Subject’s insomnia was evaluated on Insomnia Severity Index. Appropriate statistical tests were applied to the data derived from the clinical study to draw inferences. Results: Statistically significant reduction in mean score of stress on PSS and mean score of total sleep time were observed with the use of Passoflora extract as compared to placebo. The general psychological health significantly improved in Passiflora group compared to placebo group on day 15 and day 30. Passiflora Extract was found to be safe without producing any adverse effects. Conclusion: Passiflora incarnata(aerial parts) extract was significantly effective in reducing stress and other related symptoms. It improved sleep time and quality of sleep with no adverse events.