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.
Highlights
IntroductionIts prevalence is increasing globally [1]. Among adults, experiences of the past, occupation, family problems, and environmental factors act as some of the sources of stress. e COVID-19 pandemic has further added to the prevalence and severity of stress [1]
Stress is omnipresent, and its prevalence is increasing globally [1]
E study was conducted in accordance with Good Clinical Practice, the Declaration of Helsinki, Schedule Y, and the Ethical Guidelines for Biomedical Research on Human Subjects, issued by the Indian Council of Medical Research and New Drugs and Clinical Trials Rules 2019. is study was registered on Clinical Trials Registry-India (CTRI) on 13/11/2019 [Registration No.: CTRI/2019/11/021990]
Summary
Its prevalence is increasing globally [1]. Among adults, experiences of the past, occupation, family problems, and environmental factors act as some of the sources of stress. e COVID-19 pandemic has further added to the prevalence and severity of stress [1]. Us, stress is a major risk factor for the development of both physical and psychiatric conditions. It adversely affects cognitive ability, memory, sleep quality, and overall psychological well-being of individuals besides affecting executive functions, all these together leading to the development of somatic problems [2]. E HPA axis influences sleep: HPA activation leads to disturbed and lighter sleep, and inadequate sleep increases the HPA axis’s basal activity [4] Factors such as subtle HPA axis abnormalities and higher trait anxiety are associated with lower sleep quality and poorer cognitive functioning among healthy adults [5]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
