Disturbance of activity and attention. Disturbance of activity and attention
Conditions
Interventions
Intervention 1: Ritaline 0.4 to 1 mg per day and placebo as control group for 6 weeks. Intervention 2: Capsule Saffron 20 mg per day as intervention group for 6 weeks. Intervention 3: Capsule placebo
Treatment - Drugs
Placebo
Ritaline 0.4 to 1 mg per day and placebo as control group for 6 weeks
Capsule Saffron 20 mg per day as intervention group for 6 weeks
Capsule placebo 20 mg per day as intervention group for 6 weeks
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
6 Years to 17 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: diagnosis of ADHD based on DSM-5; age between 6-17 years old. Exclusion criteria: Intellectual disability; presence of any psychiatric disorders except for ODD; history of allergy to saffron or Ritaline; presence of any medical problem including cardiovascular diseases; presence of uncontrolled seizures; systolic blood pressure more than 120 mm Hg; resting pulse rate less than 60/minute or more than 115/minute; receiving warfarin, ASA and other antiplatelete agents; receiving any herbal medicine including fever few, garlic, ginseng, dong quai, and red clover; 14 days before any surgery; nursing and pregnancy
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of ADHD. Timepoint: Week 0 (before treatment) and Weeks 3 and 6 after treatment. Method of measurement: Teacher and Parent ADHD Rating Scale. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactProf. Shahin Akhondzadeh
Tehran University of Medical Sciences
Outcome results
None listed