The effect of Rosa canina L. and a polyherbal formulation syrups in patients with attention deficit/hyperactivity disorder: A study protocol for a multicenter randomized controlled trial

Abstract

\n Background: Attention deficit/hyperactivity disorder (ADHD) is the most common behavioral disorder in childhood and adolescence. A number of these patients do not respond to the current pharmacological treatments and there may also be drug side effects. This study aims to determine the efficacy and safety of two herbal medicine products, including Rosa canina L. (RC) and a polyherbal formulation (PHF) syrups on the clinical manifestations of ADHD in children and adolescents.Methods: Ninety ADHD patients based on DSM-5 diagnostic criteria will be randomly assigned equally to three groups: (1) RC syrup + methylphenidate (MP); (2) PHF syrup + MP; (3) placebo + MP according to the inclusion criteria (30 subjects in each group). The syrups dosage is 5 cc every 8 hours and MP has a stabilized dose for 8 weeks during the study. Moreover, Conner’s questionnaires will be completed by the teacher and parents before the intervention and then every 4 weeks. Also, the child symptom inventory-fourth edition (CSI-4) and temperament questionnaires will be completed before the intervention and every four weeks until two months.Discussion: This trial is the first experiment to determine the effects of RC and PHF syrups on the clinical manifestations of ADHD in children and adolescents. Our findings provide new insight into the effect of these herbal products on the clinical manifestations of ADHD.Trial registration: The trial was registered at https://en.irct.ir/ (Registration number: IRCT20190923044855N1). Registration date: 2020-01-14.