Efficacy and safety of ashwagandha root extract in children and adolescents with mild attention-deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled trial
Naik S, Muralidhar G, Rao BS, Agarwal S, Jain M
Journal of medicine and life · 0 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
Según la declaración de financiación del texto completo.
Publicación
- Publicado
- 2026-06-01 · J Med Life · vol. 19 · número 6 · págs. 456–466
- Editorial
- Carol Davila University of Medicine and Pharmacy Publishing House
- Citado
- 0 citas · más que el 68% de estudios similares · 0.0× el promedio de su campo
- Referencias
- 0 trabajos
- Acceso
- Acceso abierto (publicación gratuita) · CC-BY
- Áreas de investigación
- Phytochemicals and Medicinal Plants · Attention Deficit Hyperactivity Disorder · Medicinal Plants and Neuroprotection
- Palabras clave
- ashwagandha root extract, Withania somnifera, attention deficit hyperactivity disorder, children and adolescents, executive function, ADHD symptom severity, patient-reported outcomes, herbal supplementation, safety profile
- MeSH
- humans, plant roots, plant extracts, treatment outcome, double-blind method, attention deficit disorder with hyperactivity, adolescent, child, female, male, executive function
5 autores
- Mukta Jain🇮🇳MGM Medical College, Nerul
- Sunil Naik🇮🇳Government of Andhra Pradesh
- Gudla Muralidhar🇮🇳Government of Andhra Pradesh
- B.D. Rao🇮🇳Government of Andhra Pradesh
- Sanjay Agarwal🇮🇳D.Y. Patil University
Resumen
El texto original del estudio, en el idioma en que se publicó.
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 P 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.
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