A SAFETY EVALUATION AND TOLERABILITY OF SMRUTIHILLS CAPSULE AN AYURVEDA FORMULATION IN HEALTHY SUBJECTS

Abstract

Background: Due to stressful & sedentary lifestyle, unhealthy and unhygienic food habits many peoples develop lifestyle disorders which effects on body as well as mind. Every year in India prevalence rate of age associated with memory impairment was 3.6% individuals of 40 years and above. Ayurveda had described many natural memory boosting drugs which helps in increasing the memory and relieves stress. Medhya (Memory boosting) drugs i.e., Shankhpushpi, Mandukparnee, Guduchi, Brahmi, Jyotishmati, Vacha etc. promising results in increasement of cognitive functions available in Ayurveda texts. Smritihills capsule is made from the combination of such drugs. Objectives: The aim of the study was safety evaluation and tolerability of Smrutihills capsule on total clinical fitness, hematological and biochemical parameters in healthy individuals assessed on MOCA Test (Montreal Cognitive Assessment). Materials and methods: Present study was an observational clinical study conducted on 30 healthy volunteers. 2 capsules of Smrutihills capsules (500 mg) twice a day for 21 days were given to the 30 healthy volunteers. The data was assessed on clinical cognitive functions and total MOCA score. Results: The average total score of MOCA test increased significantly from 24.74 ± 3.26 to 26.47 ± 1.17 after 21st day treatment with Smrutihills Capsule as t=2.7358 and p value 0.0082. Thus, all the cognitive functions were increased significantly from baseline to completion of the treatment in healthy volunteers (P<0.05). Conclusions: Smrutihills capsule has been put to critical safety tests in healthy volunteers and found to be devoid of any adverse effects. It provides good clinical evidence to prove the efficacy and safety of Smrutihills capsule in healthy volunteers.