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
Keywords:Ashwadaat®, Withania somnifera, Insomnia, Stress
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.
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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