Efficacy and safety of ashwagandha root extract in children and adolescents with mild attention-deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled trial.

This study investigated the effects of ashwagandha root extract (ARE) supplementation on core attention-deficit/hyperactivity disorder (ADHD) symptoms, executive functioning, and patient-reported outcomes in children and adolescents with mild ADHD. Fifty-eight children and adolescents with clinically diagnosed mild ADHD were randomly assigned to either the ARE group (ARE; n = 29) or a placebo group (PLA; n = 29) in a prospective, randomized, double-blind, placebo-controlled, parallel-group design. Participants received 150 mg of ashwagandha root extract or a matched placebo gummies twice daily for 56 days. Primary outcomes were changes in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) total score. Secondary outcomes: ADHD-RS-IV inattention and hyperactivity-impulsivity subscales, Behavior Rating Inventory of Executive Function-2 (BRIEF-2) scores and Patient-Reported Outcomes Measurement Information System (PROMIS) scores. Safety markers, including routine clinical laboratory parameters, were assessed at baseline and Day 56. At Day 56, ADHD-RS-IV inattention, hyperactivity-impulsivity, and total scores were significantly lower in ARE than in PLA (P < 0.001). Significant improvements were also observed in the BRIEF-2 behavioral, emotional, and cognitive regulation indices and the global executive composite in ARE (P < 0.001). PROMIS sleep disturbance and anxiety scores improved significantly in ARE relative to PLA (P < 0.001). No significant between-group differences or clinically meaningful changes were observed in safety markers across the intervention period. No serious adverse events were reported. Supplementation with 300 mg/day of ashwagandha root extract for 56 days significantly improved ADHD symptom severity, executive functioning, and selected patient-reported outcomes in children and adolescents with mild ADHD, with a favorable safety profile.