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

Ashwagandha (<i>Withania Somnifera Linn.</i>) is known for its broad pharmacological qualities, making it useful for a variety of therapeutic applications, including treating children with attention deficit hyperactivity disorder (ADHD).This randomized, double-blind, placebo-controlled study enrolled 8 children (boys and girls) aged 5-12 years having ADHD were randomly assigned to receive either oral (chewable gummy) ashwagandha root aqueous extract (ARE) 150mg/day (n=29) or an identical placebo (n=29) for 56 days in a 1:1 ratio. The primary outcome was the ADHD Rating Scale-IV. Secondary outcomes included Behavioural Regulation Index (BRI), Emotional Regulation Index (ERI), and Cognitive Regulation Index (CRI) scores from the Behaviour Rating Inventory of Executive Function 2 (BRIEF-2), Quality of Life (QoL) as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS), and Clinician Global Impression. ARE treatment causes improvement in ADHD scores (p&lt;0.001). Children receiving ARE showed higher improvements (p&lt;0.001) in all dimensions of BRIEF-2 (BRI, ERI, and CRI) 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. One placebo patient experienced a fever, while one on ARE developed a cough. Both incidents were minor and addressed. Ashwagandha root extract is a potential therapeutic option in the management of ADHD in children.