Evaluation of Efficacy and Safety of Ashwadaat-TM botanical extract in patients with Stress and Insomnia – An Open label, multi center, non-comparative, interventional, prospective clinical study

Efficacy and Safety of Ashwadaat-TM in patients with Stress and Insomnia

Authors

  • Dr. Sanjay Tamoli Director, Target Institute of Medical Education & Research, 402/A, Jaswanti Allied Business Center, Off Link Road, Malad West, Mumbai 400064
  • Dr. Mahesh Kumar Harit Professor and Dean
  • Dr.Narendra B. Mundhe Assistant Professor
  • Dr. Sudarshan Hande Associate Professor
  • Ms. Kiran Khatau Director
  • Dr. Rajesh Giri Principal
  • Dr. Swapnali Mahadik Clinical Research Associate
  • Vinay Pawar School of Ayurveda, D. Y. Patil University, Sector 7
  • Dr. Ganesh Kolhe Assistant Professor

Keywords:

Ashwadaat®, Withania somnifera, Insomnia, Stress

Abstract

Introduction: Ashwadaat® is a proprietary extract based on standardized Ashwagandha (Withania somnifera) extract, which is a herb possessing anti-stress, anti-anxiety, anti- depressant, and sleep inducing properties.

Objective: The objective of the study was to evaluate efficacy and safety of Ashwadaat® in individuals with Stress and Insomnia.

Methods: In an Open label, multi centre, non-comparative, interventional, prospective clinical study carried out at two study sites, 30 individuals suffering from Stress and Insomnia were considered for the study after obtaining ethical clearance & informed consent.  Study participants were advised to take Ashwadaat® in a dose of 2 Capsules twice daily (500 mg Ashwadaat®) for a period of 30 days. Assessment of efficacy was done by stress by Perceived Stress Scale (PSS), severity of Insomnia on Insomnia Severity Index, assessment of quality of life (QOL) on GHQ28 scale and Serum Cortisol level (Morning). Safety related blood investigations were done for assessment of safety.

Results:

There was statistically significant reduction in stress and insomnia with the use of Ashwadaat®. A significant improvement in sleep quality along with improvement of quality of life (QOL) was seen at day 15 and day 30 as compared to the baseline scores. There was a reduction in morning Serum cortisol levels (within normal range) from baseline to 30 days. Excellent tolerability was reported over 30 days of consumption of Ashwadaat®. There were no adverse effects due to the consumption of Ashwadaat® and also the safety related laboratory parameters were within the normal range at baseline and further at the end of the study.

Conclusion: Ashwadaat® was found to be effective in reduction of stress and other associated symptoms, also effective in improving sleep quality, quality of life, without producing any adverse effects.

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Author Biographies

Dr. Sanjay Tamoli, Director, Target Institute of Medical Education & Research, 402/A, Jaswanti Allied Business Center, Off Link Road, Malad West, Mumbai 400064

Director, Target Institute of Medical Education & Research, 402/A, Jaswanti Allied Business Center, Off Link Road, Malad West, Mumbai 400064

Dr. Mahesh Kumar Harit, Professor and Dean

D. Y. Patil Deemed to be University School of Ayurveda, Nerul, Sector1, Navi Mumbai - 400706

Dr.Narendra B. Mundhe , Assistant Professor

Department of Kayachikitsa, KVTR Ayurvedic College Boradi, Tal. Shirpur, Dist.Dhule - 425428

Dr. Sudarshan Hande, Associate Professor

D. Y. Patil Deemed to be University School of Ayurveda, Nerul, Sector1, Navi Mumbai - 400706

Ms. Kiran Khatau, Director

1415 West 22nd Street-Tower Floor,Oak Brook, Illinois 60523

Dr. Rajesh Giri, Principal

KVTR Ayurvedic College Boradi,Tal.Shirpur,Dist., Dhule-425428

Dr. Swapnali Mahadik, Clinical Research Associate

Target Institute of Medical Education & Research, 402/A, Jaswanti Allied Business Center, Off Link Road, Malad West, Mumbai 400064

Dr. Ganesh Kolhe, Assistant Professor

KVTR Ayurvedic College Boradi, Tal. Shirpur, Dist - Dhule - 425428

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Published

2021-06-15

How to Cite

Tamoli, S., Harit, M. K. ., Mundhe, N., Hande, S., Khatau, K., Giri, R. ., Mahadik, S., Pawar, V., & Kolhe, G. (2021). Evaluation of Efficacy and Safety of Ashwadaat-TM botanical extract in patients with Stress and Insomnia – An Open label, multi center, non-comparative, interventional, prospective clinical study: Efficacy and Safety of Ashwadaat-TM in patients with Stress and Insomnia. International Journal For Research In Applied And Natural Science (ISSN: 2208-2085), 7(4), 06–11. Retrieved from https://gnpublication.org/index.php/ans/article/view/1557