A clinical assessment of the therapeutic effects of Ashwagandha root extract on cognitive performance, sleep, and fatigue in children aged 6–12 years

Introduction Ashwagandha ( Withania somnifera L.Dunal ) is an adaptogenic herb known to reduce stress and enhance well-being in adults. Methods This randomized, double-blind, placebo controlled, parallel-group trial evaluated the efficacy and safety of standardized Ashwagandha root extract (ARE) in children with parent-reported concerns related to attention, concentration, or memory. Eight-five healthy children aged 6-12 years were randomized to receive ARE gummies ( n = 42; 150 mg twice daily) or identical placebo gummies ( n = 43) for 8 weeks. Primary outcomes included attention, memory, and executive function assessed using the Computerized Mental Performance Assessment System (COMPASS). Secondary outcomes included overall functioning and well-being assessed using the Strengths and Difficulties Questionnaire (SDQ), Behavior Rating Inventory of Executive Function, Second Edition (BRIEF2 Parent version), Sleep Disturbance Scale for Children (SDSC), and Patient-Reported Outcomes Measurement Information System - Fatigue Scale. Safety was evaluated based on self-reported adverse events. Results Among 73 participants who completed the study (ARE, n = 39; placebo, n = 34), ARE supplementation significantly improved speed of information processing ( p = 0.040). Improvements were also observed in delayed word recall ( p = 0.038, d = 0.59), Stroop task accuracy ( p = 0.021, d = 0.61), Corsi block span ( p = 0.013, d = 0.66), and choice reaction time accuracy ( p = 0.005, d = 0.75). Additionally, SDSC scores improved, indicating better parent-reported sleep quality ( p = 0.035). No significant adverse events were reported. Conclusion These findings suggest that an eight-week supplementation with ARE is well tolerated and may enhance cognitive performance and sleep quality in children. Clinical trial registration The trial was prospectively registered with the Clinical Trials Registry of India (CTRI/2021/10/037126; dated 06/10/2021; CTRI ) and the Australian and New Zealand Clinical Trials Registry (Reg. No.: ACTRN12621000656831; ANZCTR –Registration).