Clinical evaluation of the Dr. Brain syrup in the treatment of anxiety, depression, and dementia: randomized, placebo controlled, single blinded clinical study

Abstract

Background: Epidemiological studies of Indian population show that dementia, anxiety, and depression are largely a major hidden problem in India. Ayurveda claims several plants are beneficial in cognitive disorders. The prime objective of study was to clinically evaluate polyherbal formulation (Dr. Brain syrup) and compare it with the Placebo. It was randomized, placebo controlled, single blinded clinical study, approved by Institutional Human Ethics Committee. Methods: 60 outpatients from P. D. Patel Ayurveda Hospital (8-70 years) ready to sign Informed consent form were included in study. All these patients were given either Placebo syrup or Dr. Brain syrup at similar dose of 10 ml twice a day for 6 weeks. They were evaluated based on the HADS (hospital anxiety depression scale), EDQ (early dementia questionnaire) and symptoms assessment parameters on weekly basis. Results: Result showed that there was significant reduction in HADS score at the end of the study. Moreover, the sensitivity and specificity of the HADS was observed highly relevant to detect the level of anxiety and depression by obtaining ROC curve. Numerical analysis of the EDQ was also shown eye-catching differences in patient receiving Dr. Brain syrup improved their memory at the end of the study compared to placebo group. Conclusions: This study prooves the efficacy and safety of the Dr. Brain syrup in improving the memory and reducing the level of anxiety and depression in particular diseased patients without any side effects.