SheVari4®, a proprietary root extract from Asparagus racemosus, ameliorates menopausal health: insights from a randomized, double-blind, placebo controlled clinical trial.

Abstract

Objective: Menopause marks the natural end of reproductive phase of women caused by decline in levels of estrogen, progesterone and other reproductive hormones. Asparagus racemosus (Shatavari) is a medicinal herb particularly known to be effective in alleviating women's reproductive health. Shatavarin IV, a steroidal saponin and a primary bioactive component in this herb, acts as a phytoestrogen by modulating the ER-alpha/ER-beta signalling, the TrkB-BDNF axis, and the Hypothalamic-Pituitary-Gonadal (HPG) and Hypothalamic-Pituitary-Adrenal (HPA) axes. In this study, the efficacy of SheVari4^® on alleviating the menopause-specific endocrine dysfunction and subsequent impaired quality of life (QOL) was assessed through a randomized double-blind placebo-controlled parallel arm trial conducted on 60 pre-, peri-, and post-menopausal women.

Methodology: Sixty women (age 50.0 ± 7.4 years) randomized in two equal groups were administered with 100 mg SheVari4^® or placebo capsules once daily for 8 weeks. Assessment of Menopause-Specific Quality of Life (MENQOL) along with domain scores across vasomotor, psychosocial, physical, and sexual function constituted primary endpoint analysis; changes in serum estradiol E2, Follicle Stimulating Hormone (FSH), progesterone, cortisol, Anti Mullerian Hormone (AMH), Sex Hormone-Binding Globulin (SHBG) and free testosterone were assessed as secondary endpoint analysis. Safety of the formulation was evaluated in terms of body mass index, blood biochemistry and liver function test.

Results: SheVari4 induced a 42.8% reduction in MENQOL versus placebo. Significant improvements in functioning (vs. placebo) were observed, respectively, across vasomotor (53.1% vs. 14.5%), psychosocial (53.6% vs. 9.9%), physical (39.2% vs. 6.5%) and sexual (29.4% vs. 10.7%) domains. The formulation also increased E2 (+36.44% vs. -2.08%) and progesterone (+0.30% vs. -2.88%) coupled with marked reduction in levels of FSH (-38.18% vs. +12.97%) and cortisol (-26.87% vs. +17.16%). Concomitantly, AMH, SHBG, and free testosterone were also favorably modulated. Blood biochemistry, liver function tests, and vital signs confirmed the broad-spectrum safety of SheVari4^®.

Conclusion: SheVari4^® significantly improved menopause-specific QOL and endocrine parameters in peri- and post-menopausal women, with a well-established safety profile.