Clinical Evaluation of the Pharmacological Impact of Ashwagandha Root Extract On Sleep in Healthy Volunteers and Insomnia Patients: A Double-Blind Randomized Parallel-Group Placebo-Controlled Study

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Main idea: The present study confirms that Ashwagandha root extract can improve sleep quality and can help in managing insomnia. Ashwagandha root extract was well tolerated by all the participants irrespective of their health condition and age. Additional clinical trials are required to generalize the outcome.

Abstract

Ashwagandha (Withania somnifera (L.) Dunal.) is long known for its sleep-inducing effects. Ashwagandha can be proposed as an alternative to the recommended present treatments for insomnia. This study aimed to evaluate the pharmacological effect of Ashwagandha root extract on sleep in healthy subjects and also in the subjects having insomnia.

A total of 80 eligible participants, 40 in Arm-A (healthy) and 40 in Arm-B (insomnia) were assigned to two groups, either Ashwagandha or placebo and studied for 8-weeks.

Results: In both healthy and insomnia subjects, there was a significant improvement in the sleep parameters in the Ashwagandha root extract supplemented group. The improvement was found more significant in insomnia subjects than healthy subjects. Repeat measure analysis of variance (ANOVA) confirmed the significant improvement in SOL, HAM-A outcomes, mental alertness, and sleep quality of the insomnia patients. A two-way ANOVA was used to confirm the outcomes that denoted sleep onset latency and sleep efficiency as the most improved parameters, followed by TST and WASO. All tested parameters were also statistically assessed for the significant improvement within the group both for the treatment and the placebo groups in the healthy and the insomnia datasets. Obtained results suggest statistically significant (p < 0.0001) changes between the baseline values and the end of the study results except for the HAM-A and the mental alertness scores in the healthy subject group.

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