Efficacy and Safety of Shatavari Root Extract in Managing Peri-Menopausal Symptoms—A Randomized, Double-Blind, Placebo Controlled Clinical Trial

Perimenopause is a biological process which involves hormonal and neuropsychological changes that produce clustered symptoms like vasomotor instability and sleep. Although conventional hormone therapy remains effective, safety concerns and contraindications fueled growing interest in herbal alternatives, particularly Asparagus racemosus (Shatavari). To evaluate the efficacy and safety of Shatavari root extract (500 mg/day) in alleviating the multidomain symptom burden in perimenopausal women. A randomized, double-blind, placebo-controlled clinical trial was implemented at two sites in India for a total period of 12 weeks, from June 10, 2025 to September 17, 2025 in a multicenter hospital-based setting. A total of 250 women were screened, and 150 eligible perimenopausal women aged 38–54 yrs were consecutively recruited and randomized; 145 completed the 84-day intervention (completion rate: 96.7%). Eligible participants were healthy perimenopausal women meeting predefined inclusion criteria. All randomized participants (n = 150) were included in the intention-to-treat (ITT) analysis. Participants received (1) Shatavari root extract (Aspurus) 500 mg/day (n = 73) or (2) matching placebo capsules/day (n = 72, containing 500 mg microcrystalline cellulose). Double-blinding was maintained through identical study product fill-to-finish and administration instructions. The primary endpoint quantified was changed in the Menopause Symptom Severity Inventory (MSSI-38) scores. The secondary endpoints included validated scales assessing vasomotor, psychological, cognitive, sleep, stress, fatigue, sexual, and quality-of-life domains and serum hormone levels. Safety monitoring comprised vital signs, liver, renal function test, and urinalysis. A total of 145 subjects (mean age 43.89 ± 4.49 years) completed the study; analyses were performed using the ITT population (n = 150). The active group showed significant improvements in MSSI-38 frequency scores versus placebo on Day 84 [30.71 ± 17.09 vs 65.54 ± 28.32, p < 0.001], with earlier onset of benefit; intensity scores were [23.81 ± 12.11 vs 69.74 ± 28.97, p < 0.001]. Parallel improvements were observed in hot flushes [6.73 ± 2.3] and the Menopause-Specific Quality of Life Questionnaire (MENQOL) [48 ± 27.16]. Serum hormones decreased significantly [FSH: 25.69 ± 5.85 mIU/L; LH: 4.67 ± 2.11 mIU/mL, p < 0.05]. No adverse events were reported. Shatavari was safe and well tolerated and significantly improved multidomain symptom burden, quality of life, and hormonal parameters, suggesting potential benefit as a non-hormonal intervention for perimenopausal women.Clinical Trial Registry of India (CTRI) CTRI/2025/06/088470 (https://ctri.nic.in).