Efficacy and Safety of Shatavari (Asparagus racemosus) Root Extract for Perimenopause: Randomized, Double-Blind, Placebo-Controlled Study

Purpose: Perimenopause is a natural phenomenon caused by hormonal changes, often accompanied by symptoms such as hot flashes and mood swings that can affect women’s quality of life. Due to concerns about hormonal treatments, women often seek plant-based alternatives. Shatavari ( Asparagus racemosus Willd.), a renowned herb in Ayurveda, is traditionally used for hormonal regulation and may help relieve these symptoms. Thus, the present study aimed to assess the efficacy and safety of 8-week oral administration of Shatavari root extract 300 mg once daily in women with perimenopausal symptoms. Patients and Methods: This prospective, randomized, double-blind, placebo-controlled study screened 120 women, and 80 were eligible participants and were randomly assigned to receive either Shatavari root extract (SHT; n = 40) or placebo (PL; n = 40). Seventy-three participants completed the study per protocol (SHT: n = 37; PL: n = 36). Symptom changes were assessed using scales such as the Menopause Rating Scale (MRS), Menopause-Specific Quality of Life (MENQOL) scale, Profile of Mood States (POMS) scale, and Perceived Stress Scale (PSS) at baseline, week 4, and week 8. Blood tests were also conducted to monitor hormone levels and safety markers. Results: The SHT group demonstrated a significant improvement in MRS (somato-vegetative, psychological, and urogenital domains) and PSS scores (p < 0.0001). Furthermore, it showed enhancements in fatigue (p = 0.019) at week 8, vigor (p = 0.021) at week 4, and stress reductions at week 4 (p = 0.010) and week 8 (p < 0.0001). Hot flashes improved significantly more (p = 0.002) with SHT group. Estradiol (p = 0.003), Follicle Stimulating Hormone (p = 0.028), and T3 (p = 0.021) levels increased with no adverse effects observed on liver or kidney function. Conclusion: Shatavari root extract may be an effective and safe natural intervention for the treatment of perimenopausal symptoms. Keywords: Asparagus racemosus Willd., perimenopause, randomization, shatavari root extract, MRS, POMS