Safety and efficacy of a proprietary Asparagus racemosus root extract on ovarian morphology, androgen balance, and insulin resistance in women diagnosed with polycystic ovary syndrome

Abstract

Background: Polycystic ovary syndrome (PCOS) is a common endocrine-metabolic disorder characterized by ovarian dysfunction, androgen imbalance, and insulin resistance (IR). Current treatments often target isolated symptoms and may have tolerability limitations, suggesting the need for safe, multi-targeted therapeutic alternatives. Asparagus racemosus (Shatavari), which contains steroidal saponins, demonstrates phytoestrogenic and metabolic regulatory activities and may offer potential benefits in PCOS.

Objective: To evaluate the efficacy and safety of CL22205, a standardized A. racemosus root extract, on ovarian morphology, reproductive hormones, hyperandrogenic drive, insulin sensitivity, and anthropometric outcomes in women suffering from PCOS.

Methods: In a randomized, double-blind, placebo-controlled study, 60 women (age 20–35 years) suffering from PCOS were assigned to receive either CL22205 (200 mg/day) or a placebo over a period of 84 consecutive days. The primary outcome was the change in ovarian volume from baseline. Secondary outcomes included ovarian volume, cyst size, follicle count, and menstrual cycle regularity, hirsutism score, acne severity, serum endocrine factors, insulin resistance, and anthropometric measurements. Safety was assessed through hematology, serum biochemistry, urinalysis, and monitoring of adverse events.

Results: Fifty-nine participants completed the trial. CL22205 demonstrated significant reductions (p < 0.05, vs. baseline) in ovarian volume (18.7%), cyst size (39.0%), and average follicle count (19.7%), and improved menstrual regularity (10.8%) at the end of the study. Hirsutism score (41.8%) and acne severity (40.7%) decreased remarkably. CL22205 significantly increased (p < 0.05 vs. baseline) serum levels of sex hormone binding globulin, reduced total testosterone, and lowered the luteinizing hormone: follicle-stimulating hormone ratio. Post-trial, homeostatic model assessment for IR decreased by 13.2% (p < 0.0001 vs. baseline), indicating enhanced insulin sensitivity. Reductions in body weight and waist and hip circumferences further supported the metabolic benefits. No major adverse effects were observed.

Conclusion: CL22205 exhibited reproductive, endocrine, and metabolic benefits with excellent tolerability, demonstrating its potential as a phytoceutical intervention for the management of PCOS.

Keywords: Asparagus racemosus, Clinical trial, Hyperandrogenism, Insulin resistance, Phytoceutical, Polycystic ovary