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JOURNAL TITLE: Journal of Research in Ayurvedic Sciences
Introduction: Menopause (Rajonivritti) is one of the most significant events in a woman's life and brings a lot of physiological changes that affect the life of a woman permanently. Ayurveda consider it as a normal physiological process and hence have not included it as a gynecological disorder. Objective: To evaluate the clinical efficacy and safety of Sukumara Ghritam and Brahmi Churnam in the management of menopausal syndrome in women. Materials and methods: This trial was a single-center, single arm study conducted on 49 women aged between 40 years and 55 years having amenorrhea ≥12 months; Kupperman menopausal index score ≥15; follicle-stimulating hormone (FSH) level ≥20 IU/L; and endometrial thickness ≤5 mm. Ayurvedic classical formulations, Sukumara Ghritam (6 g) 1 hour before food and Brahmi Churnam (3 g) after food were administered orally twice a day with lukewarm water for 84 days, and subsequent 28 days follow-up was without intervention. Outcome, i.e., changes in the score of menopause rating scale (MRS) and improvement in the quality of life using menopause-specific quality of life (MENQOL) questionnaire, were assessed at baseline, 84th day, and 112th day. Paired sample t test was used to compare mean change from baseline to 84th day and 112th day. p value < 0.05 was considered significant. Results: The results reveal that the effect of therapy in decreasing MRS total score was statistically significant (p value < 0.001). The mean score at the baseline was 7.14 (7.47), at 84th day 4.55 (2.67), and 3.33 (2.53) at 112th day (follow-up period without trial interventions). The improvements in MENQOL in four domains, namely, vasomotor, psychosocial, sexual, and physical, were also significant (p value < 0.001) at 84th day and 112th day in comparison to the baseline. All the safety laboratory parameters such as liver and renal function tests remained within the normal limits throughout the trial period, and no adverse events/adverse drug reaction were reported. Conclusion: Sukumara Ghritam and Brahmi Churnam are found to be safe and effective in the management of menopausal syndrome.
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