Abstract
Background Menopause is a significant transitional phase in women's lives, characterized by hormonal fluctuations that often entail quality-of-life-altering symptoms. These can include hot flashes, mood changes, and sleep disturbances, among others. Though hormone replacement therapy (HRT) may alleviate some menopausal symptoms, it is not appropriate for all individuals. The Shatavari plant (Asparagus racemosus) has long been utilized in traditional Ayurvedic medicine to support women's reproductive health, though rigorous clinical evidence for its efficacy remains limited. Methods In this study, we evaluated a standardized A. racemosus root extract (SheVari4®) in improving menopausal symptoms across somatic, psychological, and urogenital domains. A total of 60 healthy (pre-, peri-, and post-menopausal) women aged 40-55 years were recruited and randomized into two groups to receive daily doses of either 100 mg of placebo or SheVari4® via double-blinded administration. Menopausal symptoms were assessed at baseline (pre-treatment), and at four and eight weeks (post-treatment), using the Menopause Rating Scale (MRS). Results Confirming successful randomization, both groups reported similar baseline MRS scores (~15 on a 44-point scale). However, post-treatment, the SheVari4® group demonstrated a significant reduction in menopausal symptom severity at week 4 (43% decrease) and at week 8 (71% decrease, linear mixed model (LMM) analysis, p < 0.001). Additionally, several parameters across MRS subscales showed significant improvement with SheVari4®, including hot flash occurrence and sleep quality (both >90% improved at week 8). Adverse events were mild, transient, and comparable between groups, with gastrointestinal discomfort being the most common. Conclusion These findings suggest that SheVari4® may represent a promising botanical alternative for women seeking non-HRT approaches to manage menopausal symptoms.