Effect of Brahmi ghrita on cognitive, neurodegenerative and neurotrophic parameters in Mild Cognitive Impairment – A Double-blind Randomized Placebo-controlled Trial

MCI represents a transitional stage between healthy aging and dementia, and affects 10–15% of the population and The annual conversion rate from MCI to AD has been reported as 10 to 15% (Dubois B etal2010, Albert MSetaal 2011,)and 80% of these patients will have converted to AD after approximately six years of follow-up. Currently, there are no accepted pharmacologic treatments for MCI approved by the FDA. Pharmacological and nonpharmacological treatments are used to prevent more reduction of cognition in MCI (Pinto C etal 2009) and is limited to the patients who are at higher risk of transition to AD. Brahmi is a promising herb known for its cognitive-enhancing properties and is widely used. 

This study is a Double-blind randomized placebo-controlled trial to evaluate the efficacy of Brahmi ghrita in a dose of 15 ml twice daily for a period of 12 weeks in patients diagnosed with amnestic single or multi-domain MCI. The trial group will receive brahmi ghrita and the Control group will receive plain cow ghee in addition to the standard care they receive. The sample size is 30 in each groups. The primary outcome measure involves memory, attention and executive functions which will be assessed using NIHANS Neuropsychological battery for the elderly. secondary outcome measures are Neurofilament lite chain (marker of degeneration) and BDNF (neurotrophic factor). The duration of intervention is for 12 weeks with two assessment points at baseline and after 12 weeks.