Efficacy and Safety of Rosa canina L. and a Traditional Polyherbal Formulation Syrup in Children and Adolescents With Attention‐Deficit/Hyperactivity Disorder: A Factorial Randomized Double‐Blind Placebo‐Controlled Clinical Trial

ABSTRACT Attention‐deficit/hyperactivity disorder (ADHD) is a neuropsychiatric disorder in children and adolescents. A number of patients do not respond adequately to psychostimulant medications or sometimes experience intolerable side effects. The present study was conducted to determine the efficacy and safety of Rosa canina L. and a traditional polyherbal formulation (PHF) syrup on ADHD as a complementary treatment. Ninety ADHD patients aged 5–14 years based on DSM‐5 diagnostic criteria were randomly divided into three groups to receive (1) R. canina syrup + methylphenidate (MPH), (2) PHF syrup + MPH, and (3) placebo syrup + MPH for 8 weeks. The Conners' Teacher Rating Scale (CTRS) and Conners' Parent Rating Scale (CPRS) as well as the Child Symptom Inventory‐4 (CSI‐4) questionnaires were completed before the intervention and then every 4 weeks for 2 months. The results showed that the decreasing trend of intra‐group changes in the sum of CTRS, CPRS, and CSI‐4 was statistically significant in three groups ( p < 0.0001, p < 0.0001, p < 0.001, respectively). The study of intergroup changes in the CTRS ( p = 0.02) and CSI‐4 ( p = 0.04) was significant and the CPRS was not significant ( p = 0.15). Also, a significant increase in the total quality of life scores was reported in the three groups ( p < 0.0001), but no significant difference was observed between them ( p = 0.27). Therefore, R. canina and PHF syrups in combination with standard medical treatment could provide more clinical benefits for ADHD patients.