<b>Ashwagandha Root Extract in Treatment of Mild Attention Deficit Hyperactivity Disorder (ADHD) in Children Aged 5–12 Years: A Prospective, </b><b>Double-Blind, Randomized, Placebo Controlled Study</b>

Background and Aim: Ashwagandha (Withania Somnifera Linn.) is known for its broad pharmacological qualities, including treating children with attention deficit hyperactivity disorder (ADHD). The aim of the study is to evaluate the safety and effectiveness of Ashwagandha root extract (ARE) in children with ADHD Experimental procedure: In this randomized, double-blind, placebo-controlled research, 58 boys and girls aged 5-12 years having ADHD were randomly assigned to receive either oral ashwagandha root aqueous extract (ARE) 150mg/day (n=29) or an identical placebo (n=29) for 56 days. The primary outcome was change in scores of the ADHD Rating Scale-IV. Secondary outcomes included change from baseline in the Behavioural Regulation Index (BRI), Emotional Regulation Index (ERI), and Cognitive Regulation Index (CRI) of the Behaviour Rating Inventory of Executive Function 2 (BRIEF-2), and Quality of Life (QoL) assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS), and Clinician Global Impression (CGI). The clinical safety was evaluated using adverse events. Results: ARE treatment for 56 days in children having ADHD resulted in a significantly higher improvement in ADHD scores (p&lt;0.001). Children receiving ARE showed higher improvements (p&lt;0.001) in all dimensions of BRIEF-2 and PROMIS (p&lt;0.001). All patients reported an improvement on the CGI scale after receiving ARE, whereas 65.5% reported no change and 34.5% indicated minimal deterioration with placebo. One patient from placebo and ARE reported fever and cough respectively. Both incidents were minor and addressed. Conclusion and implications: Ashwagandha root extract is a potential therapeutic option and safe in the management of ADHD in children.