Randomized Placebo-controlled Double-blind Clinical Trial on the Efficacy of AYUSHMANAS in the Management of Smritidaurbalya (Cognitive Deficit)

Abstract

Background: According to modern medicine, individuals whose general intellectual functioning is significantly below average and concurrently having deficits in adaptive behavior are considered to be having cognitive deficit. It may be congenital or caused by factors such as brain injuries, neurological disorders, or mental illness. In Ayurveda, the condition can be correlated with Manasamandata. Various terms are used in the classics like Buddhimandyata, Jadata, Smritidaurbalya, etc., to denote impairment of intellectual functions. The current medications for cognitive deficit in modern medicine are not entirely satisfactory, so many patients seek alternative treatment for its management. Thus, there is a definite need to scientifically assess some of alternative treatment modalities. Objective: To assess the efficacy and safety of a coded Ayurvedic drug-AYUSHMANAS-in children suffering from cognitive deficit. Materials and methods: This is a prospective, randomized, double-blind, two-arm placebo-controlled clinical study. A total of 150 participants (75 in each arm) suffering with cognitive deficit will be included in line with inclusion and exclusion criteria. The participants of trial group will be administered with AYUSHMANAS (250 mg × 2 tablets) while in control group Placebo (250 mg × 2 tablets) will be administered twice daily after food for 180 days. A total of seven visits will be scheduled for each participant: first visit at screening day 0, 30th day, 60th day, 90th day, 120th day, 150th day, and 180th day. The outcomes intended from the study include observing changes in Binet Kamat test of intelligence (BKT) and mini-mental state examination (MMSE) and a modified MMSE (mMMSE) scores apart from assessing safety of the intervention. Observation of therapeutic and safety endpoint outcomes will be undertaken. Discussion: This clinical protocol is designed for exploring a better clinical outcome with good safety profile in the management of cognitive deficit in children. If found effective, the selected drug can be listed in the management protocol of cognitive deficit at clinical practice level in terms of better efficacy, safety, and cost-effective intervention. The selected drug may also lead to better understanding and management of cognition related problems. Trial registration: CTRI/2019/07/020324