Efficacy and Safety of She Care Juice, an Ayurvedic Polyherbal Oral Formulation, in Women With Polycystic Ovary Syndrome: A Prospective, Open-Label, Single-Arm Study.

Background Polycystic ovarian disease (PCOD) is a common endocrine disorder among women of reproductive age and is characterized by hyperandrogenism, menstrual dysfunction, and metabolic abnormalities. Existing therapeutic approaches may be associated with tolerability concerns and often fail to address the broad spectrum of PCOD manifestations. She Care Juice is a polyherbal Ayurvedic oral formulation containing 15 botanical ingredients. This study evaluated the efficacy and safety of She Care Juice in women with PCOD over a 90-day intervention period. Methods This prospective, open-label, single-arm, baseline-controlled clinical study enrolled 30 women aged 18-45 years diagnosed with PCOD, fulfilling the Rotterdam diagnostic criteria for polycystic ovary syndrome (PCOS), at a single clinical site in New Delhi, India. Participants received 30 mL of She Care Juice twice daily for 90 days. The primary efficacy outcomes included changes in hirsutism severity assessed using the modified Ferriman-Gallwey (mFG) score, serum hormonal parameters (luteinizing hormone (LH), follicle-stimulating hormone (FSH), LH/FSH ratio, and total testosterone), and menstrual symptom improvement at Day 90. Secondary outcomes included acne severity measured using the Investigator Global Assessment (IGA) scale, anthropometric measurements, quality of life assessed using the Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ), and metabolic parameters. Safety was evaluated through adverse event monitoring and laboratory investigations. Results Twenty-six participants completed the study. Mean mFG scores decreased significantly from 11.53 ± 2.87 at baseline to 4.88 ± 1.48 at Day 90 (mean change: -6.62 ± 2.35; p < 0.0001), resulting in scores below the diagnostic threshold for hirsutism. Acne severity improved substantially, with all participants achieving clear or almost clear skin by Day 90 (IGA score: 2.20 ± 0.55 vs. 0.54 ± 0.51; mean change: -1.62 ± 0.70; p < 0.001). At Day 90, 92.3% (24/26) of participants demonstrated clinically meaningful improvement in menstrual-related symptoms, including reduced menstrual symptoms and improved menstrual cycle regularity. Significant reductions were observed in body weight (-3.79 ± 1.60 kg), body mass index (-1.38 ± 0.69 kg/m²), and waist circumference (-4.41 ± 3.67 cm) (all p < 0.001). Quality-of-life outcomes improved markedly, with total PCOSQ scores increasing from 81.50 ± 25.87 at baseline to 173.90 ± 77.60 at Day 90 (p < 0.001). Hormonal parameters exhibited numerical improvements; 53.8% (14/26) of participants achieved a ≥20% reduction in the LH/FSH ratio, although overall hormonal changes did not reach statistical significance. No treatment-emergent adverse events (TEAEs) were reported, and all laboratory safety parameters remained within normal reference ranges throughout the study. Conclusions She Care Juice administration for 90 days was associated with significant improvements in hirsutism, acne severity, anthropometric measures, and health-related quality of life in women with PCOD, while demonstrating an excellent safety and tolerability profile. These findings suggest potential therapeutic benefits of this polyherbal formulation and warrant confirmation through larger randomized, double-blind, placebo-controlled trials.