Efficacy and safety of Shatavari root extract (Asparagus racemosus) for menopausal symptoms: a randomized, double-blind, three-arm, placebo-controlled study

Abstract

Menopause brings hormonal changes that can significantly affect quality of life. Herbal remedies like Shatavari ( Asparagus racemosus Willd.) and Ashwagandha ( Withania somnifera L. Dunal) are Ayurvedic herbs traditionally used for hormonal balance and associated stress adaptation. The study evaluated the efficacy and safety of Shatavari root extract (SHT) alone and, in combination with Ashwagandha root extract (ARE-SHT), in women with menopausal symptoms. This was an 8-week, randomized, double-blind, placebo-controlled, multicentric study that enrolled 135 women aged 45–65 years. Participants were randomized into three groups: SHT ( n = 45) or an ARE-SHT ( n = 45), or a placebo (PL; n = 45). The primary outcome was evaluated by the change in the Menopause Rating Scale (MRS) score at weeks 4 and 8. Secondary outcomes were evaluated by changes in Perceived Stress Scale (PSS) score, Menopause-Specific Quality of Life Questionnaire (MENQOL) score, Profile of Mood States (POMS) score, hot flashes, and mood improvement. The serum hormonal assessments and safety evaluations (liver, renal, and thyroid function) were conducted at week 8. Baseline values were comparable among the groups. Significant improvements in MRS scores were observed in the ARE-SHT group compared to SHT [Week 4 and 8 ( p < 0.0001)] and PL [weeks 4 ( p = 0.01) and 8 ( p < 0.0001)], respectively. MENQOL scores improved numerically by week 8. Esteem-related affect ( p = 0.025) and mood improvement ( p = 0.008) showed significant changes between the groups. Normal hormonal levels were maintained. Mild adverse events were reported by four participants (loose stools and dizziness in the ARE-SHT group, nausea in the SHT monotherapy group, and headache in the PL group). Shatavari root extract was safe and effective; however, combined with Ashwagandha root extract demonstrated a promising option in managing menopausal symptoms and in enhancing overall health. Future studies with longer duration and larger sample sizes across defined menopausal stages are required to confirm and extend these findings. Clinical Trial Registration Clinicaltrials.gov , identifier [NCT06716554].