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Clinical Efficacy and Safety of Ashokarishta, Ashvagandha Churna and Pravala Pishti in the Management of Menopausal Syndrome: A Prospective Open-label Multicenter Study

Introduction: The menopausal period comprises about onethird of average women’s life. During this period, women are vulnerable to conditions caused by estrogen deficiency from short-term discomfort to long-term health problems. Aim: To evaluate the clinical efficacy of Ashokarishta, Ashvagandha Churna and Pravala Pishti in the management of menopausal syndrome and to evaluate changes in the quality of life in women. Materials and methods: This trial was a multicenter singlearm study conducted at three Institutes of Central Council for Research in Ayurvedic Sciences. One hundred fifteen women aged between 40 and 55 years with Kupperman menopausal index score ≥15, follicle-stimulating hormone ≥20 IU/L, and endometrial thickness ≤5 mm were included in the study. Three Ayurvedic classical formulations, viz., Ashokarishta, Ashvagandha Churna and Pravala Pishti, were administered for 12 weeks followed by subsequent 2 weeks without intervention follow-up. Outcome measures were changes in menopausal symptoms using menopause rating scale (MRS) and improvement in the quality of life using menopause-specific quality of life (MENQOL) questionnaire and they were assessed at the baseline, 84th day, and at the end of 2 weeks after the completion of intervention period. Paired sample t-test was used to compare mean change from baseline to 84th day. A p-value <0.05 was considered significant. Results: The findings of the study reveal that the effect of therapy has shown statistically significant decrease in MRS total RESEARCH ARTICLE 1,6-8Research Officer (Ayurveda), 2,4,5Research Officer (Ayurveda) S-2, 3Former Research Officer (Ayurveda) S-4, 9Statistical Officer 10Statistical Assistant, 11Deputy Director General, 12Former Deputy Director General, 13Director General 1,2Regional Ayurveda Research Institute for Mother and Child Health Care, Nagpur, Maharashtra, India 3Regional Ayurveda Research Institute for Lifestyle Related Disorders, Thiruvananthapuram, Kerala, India 4Ayurveda Contraceptive Drug Research Institute, Ahmedabad Gujarat, India 5-13Central Council for Research in Ayurvedic Sciences New Delhi, India Corresponding Author: Sarada Ota, Research Officer (Ayurveda), Central Council for Research in Ayurvedic Sciences New Delhi, India, Phone: +919810425662, e-mail: sarada_ota@ yahoo.com score (p-value <0.001). The mean MRS total score at the baseline was 22.43 and decreased to 5.29 after treatment at 84th day, and further reduced to 5.06 at the 14th week (follow-up period without trial interventions). The improvements of MENQOL in four domains, viz., vasomotor, psychosocial, sexual, and physical, at the end of 12th week and 14th week were also significant (p-value <0.001) in comparison with the baseline. Further, all the safety parameters like liver function tests and kidney function tests remained within the normal limits throughout the trial period and no adverse events or adverse drug reaction were reported, which confirm the clinical safety of the trial drugs. Conclusion: Ashokarishta, Ashvagandha Churna and Pravala Pishti are found to be safe and effective in the management of menopausal syndrome.