Effects of Bacopa monnieri (CDRI 08®) in a population of males exhibiting inattention and hyperactivity aged 6 to 14years: A randomized, double‐blind, placebo‐controlled trial

• Published in: Phytotherapy research 2022-02, Vol.36 (2), p.996-1012
• Main Authors: Kean, James D, Downey, Luke A, Sarris, Jerome, Kaufman, Jordy, Zangara, Andrea, Stough, Con
• Format: Article
• Language: English
• Subjects: Attention; Bacopa monnieri; Children; Clinical trials; Cognitive ability; Double-blind studies; Executive function; Hyperactivity; Mood; Placebos; Reaction time; Sleep; Sleep disorders
• ISSN: 0951-418X; 1099-1573
• DOI: 10.1002/ptr.7372

The current study investigated the efficacy of extract of Bacopa monnieri (BM; CDRI 08®) in reducing levels of inattention and hyperactivity in young children. BM has demonstrated improvements in cognitive outcomes in adults, yet little research is available on its effects in younger populations. A 14‐week randomized, double‐blind, placebo‐controlled clinical trial, with placebo run‐in and run‐out phases, investigated the effects of BM on behavioural, cognitive, mood, and sleep effects in male children aged 6 to 14 years against placebo. One‐hundred and twelve participants were recruited into the trial, with 93 datasets available for analysis. No significant behavioural differences were noted between treatment groups. Cognitive outcomes indicated decreased error‐making in children taking CDRI 08® (p = .04) and increased speed of reaction time in those taking placebo (p = .04) at study end. Improvements in cognitive flexibility (p = .01), executive functioning (p = .04), interpersonal problems (p = .02), and sleep routine (p = .04) were noted in those consuming CDRI 08® over placebo. CDRI 08® did not improve behavioural outcomes, but may have cognitive, mood and sleep benefits in children aged 6 to 14 years. Further study is required to support the findings presented here.