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2024-06-25

A Randomized, Double blind, Placebo controlled, Multicentric,Interventional, Prospective Clinical study toEvaluate Efficacy and Safety of Passiflora incarnata (AerialParts) Extract in participants with Stress and Insomnia

Source : Harit M, Mundhe N, Tamoli S, et al. (March 20, 2024)

Objective : The objective of the present study was to the evaluate efficacy and safety of SIVI
(Passiflora incarnata extract) in the management of stress and sleep problems in Indian participants in a
randomized, double-blind, placebo-controlled, clinical study.

Methods : A total of 65 participants with stress and insomnia were randomized to two groups with 32 in the SIVI (Passiflora incarnata extract) group and 33 in the placebo group. Subjects were asked to take the test substance along with water at bedtime for 30 days. The Perceived Stress Scale, quality of life using the General Health Questionnaire (GHQ-12) scale, and Insomnia Severity Index were assessed on day 1, day 15, and day 30.

Conclusion : The results of the current study indicate that Passiflora incarnata extract is beneficial in the management of stress and helps to improve sleep quality in subjects with stress and insomnia.