The aim of the present study is to evaluate the efficacy of Ginkgo Biloba 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-IV-TR diagnostic criteria for ADHD( based on duiagnosis of a child psychiatrist) will be randomly assigned to receive Ginkgo biloba tablets (80mg/day) or methylphenidate (20 mg/day for those who are <30 Kg and 30 mg/day for those who are >30 Kg) for 6 weeks. The primary outcome measure is the Teacher and Parent ADHD Rating Scale- IV. Patients will be assessed by a child psychiatrist at baseline, 21 and 42 days after the medication started.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138711151556N6
Registration date:2009-03-13, 1387/12/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-03-13, 1387/12/23
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
Expected recruitment start date
2007-04-20, 1386/01/31
Expected recruitment end date
2009-04-20, 1388/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Ginkgo biloba in the treatment of ADHD in child and adolescent: a randomized clinical trial
Public title
Ginkgo biloba in the treatment of ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Diagnosis of ADHD based on DSMIV
age between 6-17
Exclusion Criteria:
receiving of any psychotropics drugs during past two weeks, presence of any psychiatric disorders or mental retardation (I.Q. <70) except for ODD, History of Allergy to Ginkgo, presence of any medical problem including cardiovascular dieseases, presence of uncontrolled seizures
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
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz Blvd
City
Tehran
Postal code
Approval date
2007-04-20, 1386/01/31
Ethics committee reference number
5404
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
Tablet Ginkgo Biloba 80 mg/day as intervention group for 6 weeks
Category
Treatment - Drugs
2
Description
Tablet Ritalin 20-30 mg/kg/day for 6 weeks as control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Prof. Mohammad Reza Mohhamadi
Street address
Roozbeh Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Foutouhi
Street address
Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
5404
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
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
City
Tehran
Postal code
13337
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
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
City
Tehran
Postal code
13337
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)