Efficacy of Amritadi formulation in Post Menopausal Syndrome: A Randomized Controlled Trial

Post Menopausal syndrome, a complex and multifaceted condition, affects women during the natural transition from reproductive to non-reproductive years. It encompasses a variety of physical, psychological, and hormonal changes that can significantly impact a woman’s quality of life. The prevalence of Post Menopausal syndrome varies globally, with an estimated 25% of women experiencing severe symptoms that require medical intervention. Despite its prevalence, the syndrome is often underdiagnosed and undertreated, leading to unnecessary suffering for many women.In Ayurveda, the Menopausal period around the age of 50 is described as "Rajonivrithi" or "Rajakshaya," marking a transition from the pitta predominant middle stage of life (madhyamavastha) to the vata predominant elderly stage (vridhavastha). During this phase, there is a disturbance in the balance of pitta and kapha doshas, with vata dosha becoming dominant and there is a generalized Kshayavastha hence the line management is focussed on vatapittasamana, rasa rakta prasadana, balya and rasayana. In traditional Ayurvedic practice, Bala (Sida Cordifolia) and Satavari (Asparagus racemosus) are commonly utilized to alleviate Post Menopausal symptoms. This study is to determine the efficacy of the Amritadi tablet, in mitigating Post Menopausal symptoms, in comparison with the control group administered with Satavari tablet, when assessed using the Menopause Rating Scale (MRS). In this randomized controlled trial,76 Post Menopausal women between 45and 55 years, exhibiting Post Menopausal symptoms and scoring above 14 on the Menopause Rating Scale (MRS), will be recruited from the Govt. Ayurveda College Hospital, Thiruvananthapuram. Participants will be randomly allocated to receive either Amritadi tablet (2 tablets each, twice daily before food) or Satavari tablet (2 tablets each, twice daily before food) for 90 days. The primary endpoint will be the alteration in MRS scores, while secondary endpoints will encompass evaluations by the Greene Climacteric Scale (GCS), and Post Menopause-Specific Quality of Life (MENQOL), and Psychological General Wellbeing Index (PGWBI). The study is anticipated to provide data on the Amritadi formulation’s effectiveness in reducing vasomotor, somatic, psychological, and sexual symptoms of Post Menopause. The analysis will primarily focus on the differences in MRS scores from baseline through the treatment and follow-up stages.