A CLINICAL STUDY TO EVALUATE COMPARATIVE CLINICAL EFFICACY AND SAFETY OF BHC9612CP ON COGNITIVE FUNCTION IN ADULT SUBJECTS

Dr. Harish S.*, Madhu Krishnamani and Gaurav Soni

ABSTRACT

Background: Ashwagandha has been used since many years for improving Memory and Cognitive Functions in traditional medicine. In Ayurvedic medicine, Withania somnifera (Ashwagandha) is commonly being used for its broad spectrum of pharmacological actions. Ashwagandha is traditionally used as a rasayana (tonic) that works in a holistic manner to promote overall health and vitality. Ashwagandha is known for its memory boosting and restorative functions and is also reported to reverse loss of memory in by promoting the neurogenesis and growth of brain cells. Similarly root extract of the plant and one of its active component withanolide. A has been shown to improve spatial memory and cognitive deficits in temporal lobe epilepsy and experimental model of stroke. (Shaffi Manchanda et al. 2017). Ashwagandha extract has been suggested in the treatment of various neurological disorders due to its neuroprotective and anti-degenerative properties. Hence this clinical trial is conducted to evaluate the safety and efficacy of Ashwagandha extract in patients with memory impairment. Objectives: To evaluate comparative clinical Efficacy and Safety of BHC9612CP on Cognitive Function in Adult Subjects. Conclusion: After 56 days of treatment with Ashwagandha extract BHC9612CP there was significant improvement in MMSE scores. The safety results of this study demonstrated the formulation is safe and well tolerated when administered orally. Hence, from this study it can be concluded that Ashwagandha extract BHC9612CP favourably influences cognitive functions in memory impairment subjects and is safe orally.

Keywords: Withania somnifera (L.) Dunal; ashwagandha; cognition; efficacy; memory; safety.