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. 2021 Nov 30:2021:8254344.
doi: 10.1155/2021/8254344. eCollection 2021.

Efficacy and Safety of Ashwagandha Root Extract on Cognitive Functions in Healthy, Stressed Adults: A Randomized, Double-Blind, Placebo-Controlled Study

Kumarpillai Gopukumar  1 , Shefali Thanawala  2 , Venkateswarlu Somepalli  3 , T S Sathyanaryana Rao  4 , Vijaya Bhaskar Thamatam  5 , Sanjaya Chauhan  5
Affiliations

Efficacy and Safety of Ashwagandha Root Extract on Cognitive Functions in Healthy, Stressed Adults: A Randomized, Double-Blind, Placebo-Controlled Study

Kumarpillai Gopukumar et al. Evid Based Complement Alternat Med. .

Abstract

Background: The global prevalence of stress is increasing. Stress adversely affects cognitive ability, sleep quality, and overall psychological well-being. Ashwagandha (Withania somnifera (L.) Dunal), an essential medicine in Ayurveda, is reportedly beneficial in reducing stress and improving memory. This double-blind, randomized, placebo-controlled clinical study evaluated the effect of Ashwagandha root extract sustained-release capsule 300 mg (Prolanza™; hereafter Ashwagandha SR) on cognitive functions, stress levels, sleep quality, overall well-being, and safety in stressed subjects.

Methods: Subjects (130 healthy cognitively sound adults [20-55 years, body mass index:18-29 kg/m2]) having a Perceived Stress Scale (PSS) score of 14-24 were randomized to receive either Ashwagandha SR or placebo. Subjects took one capsule of Ashwagandha SR or placebo daily for 90 consecutive days. This study was registered on Clinical Trials Registry-India (CTRI) on 13/11/2019 [number: CTRI/2019/11/021990]. The primary endpoint was the change in cognitive function as measured by CANTAB from baseline to the end of the study period (90 ± 7 days). The secondary outcomes included the change in PSS-10 score, serum cortisol level (9-11 am), the OHQ score, the PSQI, and serum BDNF levels.

Results: Only 125 completed the study and were evaluated. The Cambridge Neuropsychological Test Automated Battery (CANTAB) reported significantly improved recall memory, and the total error rate in recalling patterns significantly decreased at visit 4 in the Ashwagandha SR group vs. the placebo group (first attempt memory score:12.9 ± 6.7 vs. 10.1 ± 6.3; total errors:17.5 ± 23.3 vs. 27.7 ± 23.6). At visit 4, lower PSS-10 score (13.0 ± 5.0 vs. 18.7 ± 4.6; p < .0001), serum cortisol levels (p=0.0443), and Pittsburgh Sleep Quality Index (PSQI) score (p < .0001) but higher Oxford Happiness Questionnaire (OHQ) scores (p < .0001) were seen in Ashwagandha SR vs. the placebo group, suggesting significantly lower stress levels and significantly better psychological well-being and sleep quality in the former. No adverse events were reported.

Conclusions: This is the first clinical study assessing Ashwagandha SR for its safety and efficacy. Treatment with one Ashwagandha SR capsule once daily for 90 days improved memory and focus, psychological well-being, and sleep quality, reduced stress levels, and was safe and well-tolerated.

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Conflict of interest statement

Shefali Thanawala is an employee of Inventia Healthcare Ltd. Venkateswarlu Somepalli is an employee of Laila Nutraceuticals. Vijaya Bhaskar Thamatam and Sanjaya Chauhan are employees of In Vitro Research Solutions (iVRS) Pvt Ltd. Publication of these results should not be considered an endorsement of any product used in this study by any organizations or universities where the authors are affiliated. The authors do not have any other conflicts of interest to declare.

Figures

Figure 1
Figure 1
Overview of study design. ALT, alanine aminotransferase; AST, aspartate aminotransferase; BDNF, brain-derived neurotrophic factor; CANTAB, Cambridge Neuropsychological Test Automated Battery; CBC, complete blood count; IP, investigational product; OHQ, Oxford Happiness Questionnaire; PSQI, Pittsburgh Sleep Quality Index; PSS, Perceived Stress Scale; MoCA, Montreal Cognitive Assessment.
Figure 2
Figure 2
Consolidated Standards of Reporting Trials (CONSORT) flow diagram.
Figure 3
Figure 3
Within-group and between-group differences for CANTAB scores of PALFAMS (a), PALTEA (b), and RVPA (c) from baseline to the last visit. CANTAB, Cambridge Neuropsychological Test Automated Battery; PAL, Paired Associates Learning; PALFAMS, PAL First Attempt Memory Score; PALTEA, PAL Total Errors (Adjusted); RVPA, Rapid Visual Information Processing A Prime.
See this image and copyright information in PMC

References

    1. Nader S., Hosseinian-Far A., Jalali R., et al. Prevalence of stress, anxiety, depression among the general population during the COVID-19 pandemic: a systematic review and meta-analysis. Globalization and Health . 2020;16(1):1–11. - PMC - PubMed
    1. Jianhui W., Yan J. Stress and cognition. Frontiers in Psychology . 2017;8:p. 970. - PMC - PubMed
    1. Gregor D., Frings C. Stress and cognition in humans. Journal of Experimental Psychology . 2020;67:73–76. - PubMed
    1. van Dalfsen J. H., Markus C. R., Markus C. R. The influence of sleep on human hypothalamic–pituitary–adrenal (HPA) axis reactivity: a systematic review. Sleep Medicine Reviews . 2018;39:187–194. doi: 10.1016/j.smrv.2017.10.002. - DOI - PubMed
    1. Labad J., Salvat-Pujol N., Armario A., et al. The role of sleep quality, trait anxiety and hypothalamic-pituitary-adrenal axis measures in cognitive abilities of healthy individuals. International Journal of Environmental Research and Public Health . 2020;17(20):p. 7600. - PMC - PubMed