A Evaluation of Efficacy and Safety of TulsiOdaat™ in Patients Suffering from Insomnia Disorder - An Open Label, Single Arm, Multi-Centric, Non- Comparative, Interventional, Prospective, Clinical Study

Authors

  • Dr. Mahesh Kumar Harit Professor and Dean, DY Patil Deemed to be University School of Ayurveda, Nerul, Navi Mumbai
  • Dr. Shailesh Deshpande Professor, Parul Institute of Ayurved, Parul University, Vadodara, Gujarat State, India
  • Dr. Shishir Pande Professor, Ayurved Seva Sangh, Nashik, India
  • Dr. Kavita Hande Assistant Professor, Dept of RSBK, D Y Patil Deemed to be University, School of Ayurveda, Nerul, Navi Mumbai, India
  • Dr. Sanjay Tamoli Director, Target Institute of Medical Education & Research, 402/A, Jaswanti Allied Business Center, Off Link Road, Malad West, Mumbai, India
  • Kiran Khatau Lodaat Pharma, USA
  • Vinay Pawar School of Ayurveda, D. Y. Patil University, Sector 7, Navi Mumbai, India
  • Dr. Swapnali Mahadik Target Institute of Medical Education & Research, Mumbai, India

DOI:

https://doi.org/10.53555/ans.v7i8.1826

Keywords:

Tulsi, Insomnia, Holy Basil, Sleep disorders

Abstract

Background- Holy Basil (Ocimum sanctum) has been prescribed in Ayurvedic texts for the management of insomnia which possesses sleep-inducing and neuroprotective properties.

Objectives- The objective of the study was to evaluate the efficacy and safety of TulsiOdaat™, a botanical ingredient extract in patients suffering from mild to moderate Insomnia Disorder.

Materials & Methods- After ethics committee approval and subsequent registration of the study on CTRI, 31 consented patients, suffering from insomnia attending out-patient department of the three study centers were enrolled in the study. Patients were advised to take TulsiOdaat™ in a dose of 2 Capsules twice daily (500mg TulsiOdaat™) for a period of 30 days.

Assessment of insomnia was done on various objective and subjective efficacy parameters. Safety was assessed by clinical review of all safety parameters, including the adverse event reporting. Intra-group comparison was done by paired t-test or Wilcoxon matched-pairs signed-ranks. P-Value < 0.05 was considered significant.

Results-

TulsiOdaatTM significantly improved total sleep time and sleep efficiency as well helps provide relief in symptoms of mild to moderate insomnia with no significant rebound of insomnia. There was no significant change in safety parameters from baseline to 90 days follow up.

Conclusion:

Thus, it can be concluded that TulsiOdaat™ botanical ingredient extract is safe and effective for the treatment of primary insomnia.

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Published

2021-09-30

How to Cite

Harit, M. ., Deshpande, S. D., Pande, S. ., Hande, K., Tamoli, S. ., Khatau , K. ., Pawar, V., & Mahadik , S. (2021). A Evaluation of Efficacy and Safety of TulsiOdaat™ in Patients Suffering from Insomnia Disorder - An Open Label, Single Arm, Multi-Centric, Non- Comparative, Interventional, Prospective, Clinical Study. International Journal For Research In Applied And Natural Science, 7(8), 01–06. https://doi.org/10.53555/ans.v7i8.1826

Issue

Vol. 7 No. 8 (2021): International Journal For Research In Applied And Natural Science (ISSN: 2208-2085)

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Articles

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