A prospective, randomized, double-blind, placebo-controlled study on efficacy and safety of Ashwagandha root extract (Withania somnifera) for managing menopausal symptoms in women

Background Menopausal hormone therapy (MHT) is one of the most recent therapeutic options available for the management of menopausal symptoms. MHT is used in healthy symptomatic women under 60 or within 10 years of menopause without contraindications. Still, as many menopausal women use both MHT and antidepressants, safer alternatives are needed. Herbal remedies like Ashwagandha can offer a safer alternative to existing therapies. Ashwagandha aids in hormonal balance, vitality, and reduces stress and fatigue. Objective The study aimed to assess the efficacy and safety of Ashwagandha root extract (ARE) for managing menopausal symptoms. Methods A randomized, double-blind, placebo-controlled study included 60 women aged 45–55 years who received either ARE or a placebo (PL) for 56 days. The primary outcome was a change in the Menopause Rating Scale (MRS) score from baseline to 56 days. Secondary outcomes were changes in serum hormonal parameters [estradiol, progesterone, luteinizing hormone (LH), and follicle-stimulating hormone (FSH)], hot flash events, Short Form-12 Health Survey (SF-12) (Quality of Life) score, and Perceived Stress Scale-10 (PSS-10) from baseline to day 56. Tolerability was measured using Patient Global Assessment of Tolerability to Therapy. Safety outcomes, such as change in severity and frequency of adverse events, were also assessed from baseline to day 56. Results At the end of the study, the total MRS score reduced significantly ( p < 0.0001) with ARE intervention, in psychological ( p < 0.0001), somatic ( p < 0.0001), and urogenital ( p < 0.0001) domains as compared to the PL group. Similarly, ARE group showed improved serum estradiol ( p < 0.001) and progesterone ( p < 0.001) levels, and increase in SF-12 scores ( p < 0.001), while presenting reduced serum FSH ( p < 0.001) and LH ( p < 0.001), hot flashes events ( p < 0.001) and PSS-10 scores ( p < 0.001) compared to PL. Conclusion Ashwagandha root extract can be a potential herbal intervention for managing menopausal symptoms in healthy women. Clinical Trial Registration https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=OTk3Mw==&Enc=&userName= , CTRI/2022/02/040551.