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.

Background: Perimenopause is the period during which many physiological changes mark the transition into the final menstrual period of a woman and these changes are associated with climacteric symptoms.Objectives: This study aimed to assess the efficacy and tolerability of an Ashwagandha root extract on the climacteric symptoms, quality of life (QoL), and hormonal parameters in perimenopausal women. Materials and Methods: In this 8-week, randomized, double-blind, placebo-controlled study, 100 women with climacteric symptoms were randomly allocated to take either a placebo or 300 mg of an Ashwagandha root extract twice daily. Outcomes were measured using the menopause rating scale (MRS), menopausespecific QoL (MENQoL), hot flash score, and hormonal changes in estradiol, follicle-stimulating hormone (FSH), luteinizing hormone (LH), and testosterone. Results: Among 100 participants enrolled, 91 participants completed the study. In comparison with the placebo, ashwagandha supplementation was associated with a statistically significant reduction in total MRS score (p < 0.0001), reflected by significant reductions in the psychological (p = 0.0003), somato-vegetative (p = 0.0152), and urogenital (p < 0.0001) domains. Ashwagandha intake demonstrated a statistically significant reduction in total MENQoL scores (p < 0.0001) and was also associated with a statistically significant increase in serum estradiol (p < 0.0001) and a significant reduction in serum FSH (p < 0.0001) and serum LH (p < 0.05) compared with the placebo. There was no significant between the group differences in the serum testosterone level. Conclusion: These findings suggest that ashwagandha root extract can be a safe and effective option to relieve mild to moderate climacteric symptoms during perimenopause in women.

Background and Aim: In Ayurveda, ashwagandha is a popular plant for promoting youthful energy, longevity, and overall well-being. It is also an excellent aphrodisiac herb that aids in the improvement and maintenance of normal sexual health. The present study aims to evaluate the effect of ashwagandha root extract on improving sexual health in adult males.Methods: In this 8-week randomized, double-blind, placebo-controlled study, we investigated the aphrodisiac property of an ashwagandha root extract in adult males.Fifty participants with lower sexual desire were randomly allocated to take 300 mg of ashwagandha root extract or placebo capsules twice daily. Outcomes were measured using the derogatis interview for sexual functioning-male (DISF-M) questionnaire, serum testosterone, serum prolactin, and short-form survey-36 quality of life questionnaire before and after the intervention.Results: Compared to placebo, ashwagandha root extract supplementation was associated with a statistically significant increase in the total DISF-M scores (mean difference −9.8; 95% confidence interval, −10.73 to −8.87; p < 0.0001; t-test). It was also associated with a statistically significant increase in serum testosterone levels (−66.52; −80.70 to −52.34; p < 0.0001; t-test). However, the prolactin level did not change after intervention in both the ashwagandha and placebo groups (−1.06; −2.78 to 0.66; p > 0.05). Conclusion:These findings suggest that ashwagandha demonstrated a significant subjective perception of sexual well-being and assisted in increasing serum testosterone levels in the participants.