Obstetrics & Gynecology · Medical Literature
Efficacy and Safety of Shatavari Root Extract in Managing Peri-Menopausal Symptoms-A Randomized, Double-Blind, Placebo Controlled Clinical Trial.
Abstract
CTRI/2025/06/088470 (https://ctri.nic.in).
Clinical relevance
Perimenopausal women represent a large and underserved clinical population who increasingly avoid hormone replacement therapy (HRT) due to well-documented risks of breast cancer, thromboembolism, and cardiovascular events established by the Women's Health Initiative. This RCT addresses a critical evidence gap by rigorously evaluating Shatavari (Asparagus racemosus) root extract — an Ayurvedic phytoestrogenic botanical with steroidal saponins (Shatavarins) — as a non-hormonal alternative for managing vasomotor, psychological, and urogenital perimenopausal symptoms. Given the growing demand among patients for evidence-based botanical therapies and the limited number of well-designed trials in this area, these findings are timely and directly relevant to gynecologists and integrative medicine practitioners.
Key findings
1. MRS Composite Symptom Reduction: SHT 300 mg/day demonstrated statistically significant improvement across all three MRS domains — somato-vegetative, psychological, and urogenital — vs. placebo (p < 0.0001), indicating broad-spectrum efficacy on climacteric symptoms. 2. Vasomotor Symptom Relief: Hot flash scores were significantly reduced in the SHT group vs. placebo by week 8 (mean change: −3.84 ± 3.79 vs. −1.03 ± 3.78; p = 0.002); a non-significant trend was observed at week 4 (p = 0.090). 3. Perceived Stress (PSS-10): SHT produced progressive and statistically robust reductions in perceived stress vs. placebo at both week 4 (−2.65 ± 6.43 vs. +1.06 ± 5.54; p = 0.010) and week 8 (−7.11 ± 6.95 vs. +3.81 ± 4.97; p < 0.0001). 4. POMS Mood Subscales: Significant between-group improvements were observed in fatigue at week 8 (p = 0.019) and vigor at week 4 (p = 0.021), suggesting early onset and sustained psychoaffective benefit. 5. Endocrine Biomarkers: Serum estradiol (p = 0.003), FSH (p = 0.028), and T3 (p = 0.021) levels increased significantly in the SHT group, providing objective endocrine correlates of the observed symptomatic benefit. 6. Safety Profile: No adverse effects on hepatic or renal function were observed over 8 weeks of administration; the extract was well tolerated in the per-protocol population of 73 completers (SHT: n = 37; PL: n = 36).
Practice implications
Clinicians should consider Shatavari root extract 300 mg once daily after breakfast as a short-term (8-week) non-hormonal option for perimenopausal women with mild-to-moderate vasomotor, psychological, and urogenital symptoms, particularly those who decline or have contraindications to HRT — the extract standardized to ≥10% total Shatavarins (13:1 herb-to-extract ratio) was used in this trial. Baseline and follow-up assessment using validated scales (MRS, PSS-10) is recommended to monitor treatment response, with significant symptomatic improvement expected as early as week 4 for stress and mood outcomes and by week 8 for hot flashes. Practitioners should note that this trial was relatively short (8 weeks), conducted at a single gynecology center with a modest sample (n = 73 completers), and lacked long-term safety data or head-to-head comparisons with established non-hormonal agents (e.g., SSNRIs, gabapentin), limiting immediate generalizability; larger, longer-duration multi-center trials are warranted before definitive guideline incorporation.