“The findings suggest that [ashwagandha root extract] was well-tolerated and could serve as a safe, non-pharmaceutical herbal intervention to support cognitive performance and overall well-being in this population,” wrote researchers from India and Australia in the Frontiers in Nutrition.
Shri Kartikeya Pharma, India, which manufactures and supplies KSM-66 ashwagandha extract, provided financial support, the test product and a matching placebo for the study.
According to the researchers, it is the first to examine the efficacy of ARE as a stand-alone intervention on sleep and cognition in children.
“With further research and larger clinical trials, ARE holds potential as a dietary supplement for enhancing cognition and alleviating sleep disturbances in children, providing a complementary approach alongside conventional strategies,” they wrote.
Safety priority in children
The study comes amid heightened scrutiny of the ingredient’s safety, after several European authorities raised concerns over potential toxicity, with some even banning it.
Industry stakeholders are now urging ashwagandha suppliers to invest in stronger safety data to help ensure that the Ayurvedic ingredient remains on the European market.
“Following cognitive assessment, it is important to carefully select treatment modalities that will be devoid of adverse effects, as interventions-related adverse events introduced during early life can have a lasting impact across an individual’s lifespan,” the researchers on the current study wrote.
They also noted that current pharmacological treatment for managing attentional difficulties and behavioral disturbances in children includes stimulant medications, antidepressant and stimulant medications, all of which are associated with a range of adverse effects such as sleep disturbances, appetite suppression, gastrointestinal upset, emotional blunting and headaches.
As such, there is growing interest in exploring herbal or plant-based formulations that offer therapeutic benefits with a potential lower toxicity risk with long-term use.
Study details
The randomized, double-blind, placebo controlled, parallel-group trial 85 healthy participants (48 males and 37 females) were recruited through social media advertisements, email databases and the outpatient department at D. Y. Patil Medical College, where parents had reported concerns about their child’s attention, concentration and memory.
Participants were randomly assigned to receive a twice-daily 150 mg dose of ashwagandha root extract (ARE) standardized to >5% withanolides (KSM-66, supplied by Ixoreal Biomed Inc.) or identical placebo gummies 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, 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 the 73 participants who completed the study (ARE, n= 39; placebo, n= 34), supplementation significantly improved speed of information processing.
Improvements were also observed in delayed word recall Stroop task accuracy, Corsi block span and choice reaction time accuracy. Additionally, SDSC scores improved, indicating better parent-reported sleep quality.
The researchers noted that findings should be interpreted as preliminary and exploratory rather than definitive evidence of therapeutic efficacy. Study limitations include the relatively small sample size, short intervention duration and reliance on guardian-reported outcome measures.
“Future studies should employ larger, adequately powered designs with intention-to-treat analyses, predefined handling of missing data and appropriate multiplicity adjustments to confirm these findings and evaluate the long-term safety and efficacy of ARE supplementation,” they wrote.
Source: Frontiers in Nutrition. doi: 10.3389/fnut.2026.1742138. “A clinical assessment of the therapeutic effects of Ashwagandha root extract on cognitive performance, sleep, and fatigue in children aged 6–12 years”. Authors: Saxena A et al.
