CLINICAL TRIAL article
Front. Nutr.
Sec. Nutrition, Psychology and Brain Health
A Clinical Assessment of the Therapeutic Effects of Ashwagandha Root Extract on Cognitive Performance, Sleep, and Fatigue in Children Aged 6-12 Years
Provisionally accepted
- 1Dr. D. Y. Patil University School of Medicine, Navi Mumbai, India
- 2Clinical Research Australia, Duncraig, Australia
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Ashwagandha (Withania somnifera Linn) is an adaptogenic herb known to reduce stress and enhance well-being in adults. This randomized, double-blind, placebo-controlled, parallel-group study evaluated the efficacy and safety of Ashwagandha root extract (ARE) in children with parent-reported concerns related to attention, concentration, or memory. 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 eight 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. 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. These findings suggest that an eight-week supplementation with ARE is well tolerated and may enhance cognitive performance and sleep quality in children. 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).
Keywords: Ashwagandha, Children, Cognition, COMPASS, Memory, PROMIS, Withania somnifera
Received: 08 Nov 2025; Accepted: 23 Jan 2026.
Copyright: © 2026 Saxena, Lopresti, Sharif, Elon, Suri and Langade. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Amit Saxena
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