The aim of this triple blind randomized clinical trial is to assess efficacy of Ginco biloba on ischemic stroke outcome compared with placebo. Inclusion criterion for this research is having ischemic stroke as a patient hospitalized in Razi and Imam Reza university hospitals in Tabriz. Exclusion criteria were as: Renal and hepatic failure, warfarin or heparin consumption; pregnancy or breastfeeding; and coma. 200 patients referring to Razi university hospital diagnosed as ischemic stroke will be randomly allocated to receive either Ginco biloba or placebo. The main outcome of the trial is the effect of drug on functional status after ischemic stroke. The primary outcome of this study is functional status after stroke measured through NIHSS three times (At hospitalization, discharge and after 4 months).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138804212150N1
Registration date:2009-08-20, 1388/05/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-08-20, 1388/05/29
Registrant information
Name
Homayoun Sadeghi Bazargani
Name of organization / entity
Tabriz University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 3741
Email address
homayoun.sadeghi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of medical sciences
Expected recruitment start date
2009-08-20, 1388/05/29
Expected recruitment end date
2010-08-20, 1389/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Ginco biloba on ischemic stroke outcome
Public title
Efficacy of Ginco biloba on ischemic stroke outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Ischemic stroke hospitalization in Razi university hospital , Tabriz
Exclusion criteria:
1- Renal and hepatic failure
2- Warfarin or heparin consumption
3- Pregnancy or breastfeeding
4- Coma
Age
From 45 years old to 139 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of medical sciences
Street address
Daneshgah street , Deputy for research, Tabriz university of medical sciences
City
Tabriz
Postal code
Approval date
2008-08-01, 1387/05/11
Ethics committee reference number
8727
Health conditions studied
1
Description of health condition studied
Ischemic stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Functional status after stroke
Timepoint
At hospitalization(0), discharge(1), and after 4 months(2)
Method of measurement
Functional status score based on NIHSS(National institute of health stroke scale)
Secondary outcomes
empty
Intervention groups
1
Description
Ginkgo biloba tablets(produced with commercial name as Ginkgo TD)/ 40 mg TDS
Category
Treatment - Drugs
2
Description
Placebo as the same shape and size and color as ginkgo biloba tablets
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi and Imam reza University hospoital, Tabriz, Iran
Full name of responsible person
Dr. Mehdi Farhoudi
Street address
Golgasht street, Faculty of medicine , deputy for research
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of medical sciences
Full name of responsible person
Dr.Farhoudi
Street address
Golgasht street, Faculty of medicine
City
Tabriz
Grant name
Grant code / Reference number
grant code: 87-5 -- thesis code:87/3-5/6
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of medical sciences
Full name of responsible person
Mirmohsen Sharifi Bonab
Position
MD, Resident of neurology specialty degree
Other areas of specialty/work
Street address
Elgoli ave. Razi university hospital, neurology department
City
Tabriz
Postal code
Phone
+98 912 688 0416
Fax
Email
amirmohsen57@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of medical sciences, Tabriz, Iran
Full name of responsible person
Dr Daryoush savadi oskouei
Position
Specialist and Associate professor of neurology
Other areas of specialty/work
Street address
Neurology department,Imam reza University hospital, Golgasht ave.
City
Tabriz
Postal code
Phone
+98 41 1336 4672
Fax
Email
d.savadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of medical sciences
Full name of responsible person
Rogayyeh shami
Position
Professional
Other areas of specialty/work
Street address
Razi hospital elgoli ave.
City
Tabriz
Postal code
Phone
1- +984113810810 2-9144027218
Fax
Email
1- shami_20062001@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)