Clinical Efficacy and Safety of Brahma Rasayana in Apparently Healthy Elderly Persons: A Prospective Multicenter Open-label Study

Abstract

Background: Rasayana therapy is one of the branches of Ayurveda, which aims at promoting the excellence of Dhatu, improving inherent defense mechanisms in our body, and improving general health.Aim: To assess the clinical efcacy and safety of Brahma Rasayana in apparently healthy elderly persons.Materials and methods: The clinical study was undertaken at three peripheral institutes in different geographical areas. One hundred and eighty apparently healthy elderly persons fullling the inclusion criteria were enrolled in the study. Brahma Rasayana was administered orally in the dose of 15 grams twice a day on empty stomach with lukewarm milk for a period of 12 weeks (84th day). Parameters, like the Hamilton depression rating scale, PGI Memory Scale, WHO Quality of Life-BREF Scale, hematological parameters, lipid prole, liver function tests, renal function tests, thyroid stimulating hormone (TSH), serum calcium, and serum vitamin D3 level, were assessed before and after the administration of therapy. The paired t test was applied to compare mean changes from baseline to the 84th day.Results: A statistically significant effect (p < 0.0001) was observed at the end of the 84th day on all the four domains of the WHOQOL-BREF score, PGI Memory Scale, Hamilton depression rating scale, and chief complaints at the end of 12 weeks, compared with the baseline. Nonsignicant changes in blood parameters were obtained, proving the safety of the test drug. Also, the signicant increase in the serum vitamin D3 level and decrease in the fasting blood sugar level were observed