Protocol summary

Summary
The aim of the present study is to evaluate the efficacy of saffron on ADHD in children and adolescents through a double-blind, randomized, controlled trial. 40 outpatients, including 6-17 years old who clearly meet the DSM-5 diagnostic criteria for ADHD( based on duiagnosis of a child psychiatrist) will be randomly assigned to receive saffron Capsules (20 mg per day); methylphenidate (0.4 to 1 mg per day) or placebo for 6 weeks. The primary outcome measure is the Teacher and Parent ADHD Rating Scale. Patients will be assessed by a child psychiatrist at baseline, third and sixth weeks after the medication started.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201701131556N94
Registration date: 2017-01-13, 1395/10/24
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-01-13, 1395/10/24
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Saffron versus Methylphenidate in the treatment of Attention Deficit/ Hyperactivity Disorder: a double-blind and randomized trial
Public title
Saffron versus Methylphenidate in the treatment of Attention Deficit Hyperactivity Disorder
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 6 years old to 17 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshvarz Blvd.
City
Tehran
Postal code
Approval date
2016-12-21, 1395/10/01
Ethics committee reference number
IR.TUMS.VCR.REC.1395.1203

Health conditions studied

1

Description of health condition studied
Disturbance of activity and attention
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention

Primary outcomes

1

Description
Severity of ADHD
Timepoint
Week 0 (before treatment) and Weeks 3 and 6 after treatment
Method of measurement
Teacher and Parent ADHD Rating Scale

Secondary outcomes

empty

Intervention groups

1

Description
Ritaline 0.4 to 1 mg per day and placebo as control group for 6 weeks
Category
Treatment - Drugs

2

Description
Capsule Saffron 20 mg per day as intervention group for 6 weeks
Category
Treatment - Drugs

3

Description
Capsule placebo 20 mg per day as intervention group for 6 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Dr. Shahin Akhondzadeh
Street address
Roozbeh Hospital, South Kargar Sreeet
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Masoud Yunesian
Street address
Tehran University of Medical Sciences, Keshvarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar Sreeet
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
S.akhond@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar Sreeet
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
S.akhond@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar Sreeet
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
sakhond@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...