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= 0.254). SHT significantly reduced psychological stress (PSS score: -6.64 ± 3.99; p < 0.0001), decreased follicular count (p < 0.0001), and increased endometrial thickness (p = 0.028) compared to PL. No significant differences were observed in BMI, hormonal levels, or laboratory parameters. No serious adverse events occurred; mild to moderate events were reported in 11.4% (SHT) and 8.5% (PL) of participants, all manageable with standard therapy and not related to the intervention. CONCLUSION: Shatavari root extract oral administration can be a safe and effective potential intervention for women with PCOS. The study was registered with the Clinical Trials Registry of India (CTRI) under registration number CTRI/2024/10/074660 on October 3, 2024. CLINICAL TRIAL REGISTRATION: https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTE0ODIy&Enc=&userName=, identifier CTRI/2024/10/074660.