Efficacy and safety of Shatavari root extract in women with Polycystic Ovarian Syndrome: a randomized, double-blind, placebo-controlled trial
Abstract
Background: Polycystic Ovarian Syndrome (PCOS) is a hormonal disorder affecting women of reproductive age. It frequently causes hormonal imbalance, irregular menstrual cycle, and in some cases, infertility. For centuries, traditional herbs like Shatavari (Asparagus racemosus Willd.) have been used to support women's reproductive health, and some studies suggest it may help with PCOS symptoms. Thus, this study aimed to evaluate the safety and efficacy of standardized Shatavari root extract in women with PCOS.
Methods: This prospective, randomized, double-blind, placebo-controlled trial was conducted on women aged 20-40 years for 12 weeks. Seventy participants were randomized into Shatavari root extract (SHT, n=35) and placebo (PL, n=35) groups. Sixty-six participants completed the full 12-week trial. The primary outcome was the change in ovarian and endometrial outcomes. Secondary outcomes were the change in Body Mass Index (BMI) and Perceived Stress Scale (PSS-10) scores. Assessments were performed at baseline, week 4, week 8, and week 12. Blood samples were collected at baseline and week 12 to estimate glycated hemoglobin (HbA1c), lipid profile, and serum insulin. The serum hormones, liver, renal, and thyroid functions were also assessed. For the safety assessment, adverse events were continuously monitored.
Results: Baseline demographics and clinical parameters were comparable between groups. At 12 weeks, Ovarian volume did not differ significantly between groups (p=…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 35 participants or records.
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