Clinical assessment of CL22209, a standardized proprietary extract of Asparagus racemosus, for mitigating vasomotor and menstrual symptoms in perimenopausal women: A randomized, double-blind, placebo-controlled study

Abstract

Background: Vasomotor symptoms (VMS) and menstrual discomfort are prevalent and distressing manifestations during the menopausal transition in women, significantly impairing the quality of life (QoL). Asparagus racemosus Willd. (family: Asparagaceae) (Shatavari), a revered Rasayana herb in Ayurvedic medicine, has long been used to support female reproductive health. 

Objective: We investigated the therapeutic potential of CL22209, a standardized A racemosus root extract, in early perimenopausal women. Precisely, it assessed the extract’s ability to alleviate vasomotor symptoms, menstrual discomfort, and hormonal dysregulation through a comprehensive evaluation of symptom scores, reproductive hormone levels, ovarian follicle counts, and patient-reported outcomes, and ensuring its safety and tolerability over a 120-day supplementation.

Methods: In this randomized, double-blind, placebo-controlled investigation, 75 early perimenopausal women (aged 40–50 years) with mild-to-moderate VMS were assigned to receive either CL22209 (50- or 100 mg/day) or placebo over a period of 120 consecutive days. The primary endpoint was the change in total Menopausal Rating Scale (MRS) scores. Secondary outcomes included Hot Flash Weekly Weighted Score (HFWWS), Menstrual Symptom Questionnaire (MSQ) score, follicle count via ultrasonography, and serum levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), anti-Müllerian hormone (AMH), and 17β-estradiol (E2) in the participants. Skin and hair quality, as well as patient-reported outcomes, were also assessed. Safety and tolerability were evaluated through monitoring of hematology, clinical biochemistry, urinalysis, and adverse events.

Results: Supplementation with CL22209 at both 50 mg and 100 mg/day significantly reduced MRS scores and HFWWS as compared to baseline and placebo (p < 0.001). Menstrual symptoms, particularly spasmodic and congestive dysmenorrhea, showed marked improvement. Notably, a dose-dependent modulation of FSH, LH, AMH, and E2 levels was observed. No serious adverse events were reported.

Conclusion: CL22209 demonstrates the efficacy and safety profile as a natural, non-hormonal intervention for alleviating perimenopausal symptoms, providing clinical benefits in symptom reduction, hormonal regulation, and dermatological well-being. The study provides the first clinical evidence of CL22209’s dual central and peripheral endocrine modulation, positioning it as a novel functional food for integrative women's health support during the menopausal transition.

Keywords: Asparagus racemosus (Shatavari), Functional Food, Hormonal balance, Menopausal Rating Scale (MRS), Perimenopause. Phytoestrogens, Safety, Vasomotor symptoms.