Effectiveness of Medhasagar Rasa® in Combating Aging-Associated Mild Neurocognitive Disorder: An Open-Label, Exploratory, Interventional Clinical Trial

Introduction: With the rising prevalence of neurocognitive disorders (NCDs) among the aging population, particularly in conditions like mild cognitive impairment (MCI), which often precedes dementia, there remains a significant gap in effective pharmacological interventions. This has generated interest in exploring alternative therapies to manage symptoms and enhance cognitive function in the aging population. The primary objective of this study was to evaluate the effect of Medhasagar Rasa® on cognitive functions, daily functioning, and quality of life in participants with aging-associated mild neurocognitive disorder using the Montreal Cognitive Assessment (MoCA) Scale, Ayurvedic Manasabhava Scale, and Brief Cognitive Rating Scale (BCRS).

Methods: This open-label, interventional study at Karnatak Lingayat Education (KLE) Ayurveda Hospital, Belagavi, Karnataka, involved 32 screened participants, with 30 completing the study. Participants aged 50-70 years with MoCA scores of 18-25 received Medhasagar Rasa (2 tablets at bedtime, provided by M/s. Shree Dhootapapeshwar Limited, Mumbai, India) for 60 days. Assessments occurred at baseline and every 15 days until day 60.

Results: Thirty participants were recruited for the study after screening, all of whom completed the study. The median total MoCA score at baseline (visit one) was 20, which significantly improved to 25 by visit five (day 60±3) (p<0.001), indicating enhanced cognitive performance. The BCRS scores also showed significant improvement, with the median score decreasing from 12 to 7.5 (p<0.001) over 60 days. Anxiety symptoms were significantly reduced, with Hamilton Anxiety Rating Scale (HAM-A) scores dropping from 14 to 7 (p<0.001), while the Pittsburgh Sleep Quality Index (PSQI) scores indicated improved sleep quality, reducing from 9.5 to 7 (p<0.001). The Ayurvedic Manasabhava Scale also demonstrated a significant reduction in intensity (14 to 6; p<0.001) and frequency (13.5 to 6; p<0.001). Clinical Global Impression (CGI) scores showed stable illness severity, sustained global improvement, and consistent therapeutic efficacy. No adverse events were reported, and vital parameters remained normal throughout the study. Compliance with the medication was over 80%, and no significant changes were observed in laboratory values.

Conclusion: Medhasagar Rasa effectively enhanced cognitive functions and alleviated anxiety and sleep disturbances in aging-related mild neurocognitive disorder, offering a promising therapeutic option.