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.

Downloads

Download data is not yet available.

References

Roth T. Insomnia: definition, prevalence, etiology, and consequences. Journal of clinical sleep medicine: JCSM: official publication of the American Academy of Sleep Medicine. 2007; 3 (5 Suppl): S7–S10.

Taylor D, Mallory L, Lichstein K, Durrence H, Riedel B, Bush A. Co-morbidity of chronic insomnia with medical problems. Sleep. 2007; 30: 213–218.

Buysse D, Angst J, Gamma A, Ajdacic V, Eich D, Rössler W. Prevalence, course, and co-morbidity of insomnia and depression in young adults. Sleep. 2008; 31: 473–80.

Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med. 2008; 4: 487–504.

Thorpy M. Classification of Sleep Disorders. Neurotherapeutics. 2012; 9: 687–701.

Maness D, Khan M. Non-pharmacologic Management of Chronic Insomnia. American Family Physician. 2015; 92: 12 - 14.

Ringdahl E, Pereira S, Delzell J. Treatment of primary insomnia. J Am Board Fam Pract. 2004 May-Jun; 17(3): 212-219.

Janine M., Curry D, Walsh J. Pharmacologic Treatment of Primary Insomnia. Sleep Med Clin. 2010; 5:609–625.

Wang M, Wang S, Tsai P. Cognitive behavioural therapy for primary insomnia: a systematic review. J Adv Nurs. 2005; 50(5): 553-564.

Krystal A, Prather A, Ashbrook L. The assessment and management of insomnia: an update. World Psychiatry. 2019 Oct; 18(3): 337-352.

Deshmukh A, Deshmukh B, Shirole P. Ocimum Sanctum: A Medicinal Gift from Nature. IJP, 2015; Vol. 2(12): 550-559.

Bhooshitha A, Ghosh A, Chandan H, Nandhini H, Pramod B, Krishna K. Review On Nutritional, Medicinal and CNS Activities of Tulsi (Ocimum. Sanctum). J. Pharm. Sci. & Res. 2020; 12(3): 420-426.

Kusindarta D, Wihadmadyatami H, Haryanto A. Ocimum sanctum Linn. Stimulate the expression of choline acetyl transferase on the human cerebral micro vascular endothelial cells, Veterinary World, 2016; 9(12):1348-1354.

Bathala L, Rao C, Manjunath S, Vinuta S, Vemulapalli R. Efficacy of Ocimum sanctum for Relieving Stress: A Preclinical Study. The Journal of Contemporary Dental Practice. 2012; 13(6):782-786.

Jo K, Nam G, Park Y, Kawl H, Kim J, Choi W, et al. Evaluation of Stress-related Behavioral and Biological Activity of Ocimum sanctum Extract in Rats. Biotechnol Bioproc. 2020; E 25: 170–180.

Sateia M. International classification of sleep disorders-third edition: highlights and modifications. Chest. 2014 Nov; 146(5):1387-1394.

Cohen M. M. (2014). Tulsi - Ocimum sanctum: A herb for all reasons. Journal of Ayurveda and integrative medicine. 2014; 5(4), 251–259.

Saxena R, Singh R, Kumar P, Negi M, Saxena V, Geetharani P, et al. Efficacy of an extract of ocimum tenuiflorum (OciBest) in the management of general stress: A double-blind, placebo-controlled study. Evid Based Complement Alternat Med. 2012; 2012:894-509.

Downloads

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