Preprint / Version 1

Randomized, Double-Blind, Placebo-Controlled, Clinical Study of Passiflora incarnata in Participants With Stress and Sleep Problems

Authors

  • Mahesh Harit Department of Sanskrit Samhita Siddhant, DY (Dnyandeo Yashwantrao) Patil Deemed to be University School of Ayurveda, Navi Mumbai, IND
  • Narendra Mundhe Department of Kayachikitsa, KVTR (Karmvir Vyankatrao Tanaji Randhir) Ayurved College, Dhule, IND
  • Sanjay Sr Department of Research, Target Institute of Medical Education and Research, Mumbai, IND
  • Vinay Pawar Department of Sanskrit Samhita Siddhant, DY (Dnyandeo Yashwantrao) Patil Deemed to be University School of Ayurveda, Navi Mumbai, IND
  • Vedvati Bhapkar Department of Rasashastra and Bhaishajya Kalpana, DY (Dnyandeo Yashwantrao) Patil Deemed to be University School of Ayurveda, Navi Mumbai, IND
  • Ganesh Kolhe Department of Kayachikitsa, KVTR (Karmvir Vyankatrao Tanaji Randhir) Ayurved College, Dhule, IND
  • Swapnali Mahadik Department of Research, Target Institute of Medical Education and Research, Mumbai, IND
  • Anand Kulkarni Department of Research, JK (Jairamdass Khushiram) Botanicals Private Limited, Navi Mumbai, IND
  • Ankit Agarwal Department of Research, JK (Jairamdass Khushiram) Botanicals Private Limited, Navi Mumbai, IND

Keywords:

passion flower, sleep, stress, clinical study, sivi (passiflora incarnata extract)

Abstract

Background and objectives SIVI is a standardized extract prepared using the aerial parts of Passiflora incarnata developed to enhance the quality of sleep. ​​​​​​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. Materials and 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. Results Passiflora incarnata extract showed a statistically significant reduction in the mean score of stress on the Perceived Stress Scale and significantly increased the mean score of total sleep time compared to placebo. The general psychological health was found to be significantly improved in the SIVI (Passiflora incarnata extract) group compared to the placebo group on day 15 and day 30. SIVI (Passiflora incarnata extract) did not show any adverse effects. Conclusions 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. Keywords: passion flower, sleep, stress, clinical study, sivi (passiflora incarnata extract)

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