Prospective, Randomized, Double-blind, Placebo Controlled Study on Safety and Efficacy of Ashwagandha Root Extract (Withania Somnifera) on Menopause Symptoms

Background Hormone replacement therapy (HRT) is of the most recent therapeutic option available for management of menopausal syndrome. But the amalgamation of HRT and pharmaceutical antidepressants are linked to an elevated risk of serious adverse events. In addition, lifestyle changes are somehow ineffective in addressing the psychological signs. Hence, the present study was conducted to assess the safety and efficacy of high concentrated Ashwagandha root extract (ARE) formulation in age group experiencing menopausal syndrome with emphasis on Menopause Rating Scale (MRS). Methodology: A randomized, double-blind, placebo-controlled study was conducted for duration of eight weeks. Total 60 women with clinically diagnosed menopause were enrolled and prescribed either 300 mg of an Ashwagandha root extract capsules or placebo capsule twice daily. Results It was observed that total MRS score reduced significantly (p < 0.0001) with ARE supplementation, especially in psychological (p < 0.0001), somatic (p < 0.0001), and urogenital (p < 0.0001) domains as compared to the placebo group. Group receiving ARE capsules showed improved serum estradiol (p < 0.001), progesterone (p < 0.001) and Short Form survey (SF-12) scores (p < 0.001), while reduction in serum FSH (p < 0.001) and LH (p < 0.001), hot flashes events (p < 0.001) and Perceived Stress Scale (PSS-10) scores (p < 0.001). Conclusion To conclude, inclusion of ashwagandha for management of menopausal syndrome is a promising therapeutic option. The safety and efficacy of different concentrations of Ashwagandha could be studied further. Trial registration: The study was registered with Clinical Trial Registry of India (CTRI/2022/02/040551 dt: 23/02/2022)