A double-blind, randomized, placebo-controlled trial evaluating safety and efficacy of an ayurvedic botanical formulation in reducing menopausal symptoms in otherwise healthy women

Abstract

AimsThe aim of the present study was to examine the safety and efficacy of a formulated Ayurvedic botanical combination in reducing vasomotor and other menopause-associated symptoms in otherwise healthy women. MethodsThis was a double-blind, randomized, placebo-controlled trial conducted with 117 healthy women, aged 40–65 years using a formulated Ayurvedic medicine composed of 75 mg Tinospora Cardifolia, 100 mg Asparagus racemosus, 100 mg Withania somnifera and 225 mg Commiphora mukul per capsule, administered as one capsule twice per day over a period of 12 weeks. The primary outcome measure was menopausal symptoms assessed by the validated Menopause-Specific Quality of Life (MENQOL) questionnaire. The secondary outcome measures included a patient-reported diary of vasomotor symptoms, serum hormone levels and health indices (body weight, blood pressure, haematological and biochemistry markers). ResultsA significant difference was demonstrated for the total MENQOL score and the vasomotor (p < 0.001), psychosocial (p < 0.001), physical (p = 0.02) and sexual domains (p < 0.001) between the active treatment and placebo groups after 12 weeks. There was a significant reduction in total hot flushes, daytime hot flushes and night sweats in the active treatment group compared to the placebo group (p ≤ 0.001). There were no significant changes observed in serum hormone levels or health indices between the active and the placebo group. ConclusionThis study demonstrated a combination of Tinospora cardifolia, Asparagus racemosus, Withania somnifera and Commiphora mukul to be a safe and effective treatment for reducing menopausal symptoms in healthy menopausal women over a duration of 12 weeks.