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

  • 2022-05-23
  • Trials 23(1)
    • Haide Golsorkhi
    • Mostafa Qorbani
    • Mohammad Kamalinejad
    • Saeideh Sabbaghzadegan
    • Mohsen Bahrami
    • Mohammad Vafaee-Shahi
    • Hadi Montazerlotfelahi
    • Elham Abniki
    • Majid Dadmehr

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 30
Population
Ninety ADHD patients based on DSM-5 diagnostic criteria
Methods
randomly assigned equally into three groups: (1) RC syrup + methylphenidate (MP), (2) PHF syrup + MP, and (3) placebo + MP; syrup dosage 5cc every 8 h; MP stabilized dose for 8 weeks
Duration
8 weeks

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) syrup, 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 into three groups: (1) RC syrup + methylphenidate (MP), (2) PHF syrup + MP, and (3) placebo + MP according to the inclusion criteria (30 subjects in each group). The syrup dosage is 5cc every 8 h, and MP will have 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 4 weeks until 2 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

Iranian Registry of Clinical Trials IRCT20190923044855N1 . Registered on 14 January 2020. The trial was registered at https://www.irct.ir/ .

Research Insights

  • Rose Hip→Improved ADHD Symptoms

    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.

    Effect
    Neutral
    Effect size
    Small
    Dose
    5cc every 8 h
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