CL22209, a standardized Asparagus racemosus root extract, demonstrates improved ovarian morphology, menstrual regularity, and metabolic parameters in women with polycystic ovary syndrome in a randomized, controlled trial

Abstract

Background and objective: Polycystic ovary syndrome (PCOS) is a leading cause of infertility and metabolic dysfunction in women of reproductive age. Despite its high prevalence, current medical treatments are largely symptom-targeted and often prescribed off-label, highlighting the need for safer, integrative interventions. Botanical formulations with phytoestrogenic and insulin-sensitizing properties may represent a holistic therapeutic approach. The study aims to evaluate the clinical efficacy and safety of a standardized Asparagus racemosus root extract (CL22209) in women diagnosed with PCOS.

Methods: A randomized, double-blind, placebo-controlled clinical trial (registration no: CTRI/2023/11/059457) was conducted in 60 women aged 20–35 years who were diagnosed with PCOS, as determined by the Rotterdam criteria. Participants received either CL22209 (100 mg daily) or a placebo for 84 consecutive days. The primary endpoint was the change in ovarian volume from the baseline. Secondary outcomes included ovarian cyst size and follicle number, menstrual cycle regularity, androgen-related manifestations, anthropometric indices, hormonal parameters, insulin sensitization, and safety.

Results: After 84 days of supplementation, CL22209 significantly (P < 0.0001) reduced mean ovarian volume (20.98%), cyst size (40.97%), and follicle number (20.56%) as compared to placebo. The supplement showed exploratory indications of improved insulin sensitivity and hormonal profiles. Modest changes were also seen in menstrual patterns and anthropometric measures. CL22209 was well-tolerated over the study period.

Conclusion: CL22209 was well-tolerated and demonstrated broad-spectrum efficacy in women diagnosed with PCOS, improving ovarian morphology, metabolic health, and androgen-mediated symptoms. Future studies with larger sample sizes and longer follow-up durations would help to further validate these findings and clarify CL22209’s role in the management of PCOS.