Efficacy and Safety of Shatavari (Asparagus Racemosus) Root Extract in the Management of Menopausal Symptoms: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Abstract

Introduction: Menopause is associated with vasomotor, psychological, and somatic symptoms that impair quality of life. The objectives was to evaluate the safety and efficacy of Shatavari root extract capsule improving menopause related hormonal changes and alleviating hot flushes and other climacteric symptoms.
Methods: Multicenter, randomized, double-blind, placebo-controlled trial enrolled 70 peri- and postmenopausal women, who randomized to receive Shatavari root extract capsules (400 mg/day) or placebo for 56 days. The primary objective was to evaluate effects on hot flushes and other climacteric symptoms compared with placebo. The secondary objective was to assess effects on stress, sleep, mood, quality of life, safety and tolerability.
Results: Baseline characteristics were comparable between groups. Shatavari significantly reduced menopausal symptoms (total MRS and somatic scores), improved quality of life (MENQOL) (total and psychosocial scores) and mood (total mood, tension-anxiety, vigor-activity scores) from Day 14 compared to placebo. Significant reduction in hot flush severity, other climacteric symptoms, stress, MENQOL, mood and improvement in sleep quality observed from Day 28. Shatavari significantly modulated serum estradiol (increased) and luteinizing hormone (decreased) from Day 14 and decreased cortisol from Day 42 compared to placebo. Follicle-stimulating hormone and testosterone remained stable. No meaningful changes in hematological, hepatic, or renal parameters, and adverse events low and comparable between groups.
Conclusions: Shatavari root extract for 56 days was safe and well-tolerated and resulted in clinically improvements in vasomotor symptoms, psychological well-being, sleep quality, and quality of life in peri- and postmenopausal women, supporting as a non-hormonal, holistic for management of menopausal symptoms.