IRCT201701131556N94.

Study name	Public title: Saffron versus methylphenidate in the treatment of attention deficit/hyperactivity disorder Scientific title: Saffron versus methylphenidate in the treatment of attention deficit/hyperactivity disorder: a double‐blind and randomized trial
Methods	Parallel RCT Study duration: 6‐weeks
Participants	Sample size (target): 40 Inclusion criteria 6‐17 years Clearly meeting the DSM‐5 diagnostic criteria for ADHD Exclusion criteria Intellectual disability Presence of any psychiatric disorders except for ODD History of allergy to saffron or Ritalin Presence of any medical problem including cardiovascular diseases Presence of uncontrolled seizures SBP >120 mm Hg Resting pulse rate < 60/min or > 115/min Receiving warfarin, ASA and other antiplatelet agents Receiving any herbal medicine including fever few, garlic, ginseng, dong quai, and red clover 14 days before any surgery Nursing and pregnancy
Interventions	Saffron capsules (20 mg/d) MPH (0.4 mg‐1 mg/d) Placebo
Outcomes	ADHD symptoms Teacher and Parent ADHD‐RS assessed at baseline, week 3 and six
Starting date	20 January 2017
Contact information	Name: Shahin Akhondzadeh Telephone: + 98 21 5541 2222 Email: s.akhond@sina.tums.ac.ir
Notes	Sponsor: Tehran University of Medical Sciences Declaration of interests: not reported