The aim of this randomized double blind study is to assess the effect of Ginkgo biloba on the ischemic manifestations of scleroderma in extremities. A total of fifty patients with scleroderma and raynaud's phenomenon will be randomly assigned into two groups of 25 each. The patients in one group will receive Ginkgo biloba (Tolidaru Pharmaceutical Company) 40mg tds for 3 months while in control group will receive placebo. Raynaud's Condition Score and Score Modified Rodnan Skin will be evaluated at the end of months 1, 2, and 3 and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103062053N1
Registration date:2011-03-06, 1389/12/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-03-06, 1389/12/15
Registrant information
Name
Seideh Zahra Mirfeizi
Name of organization / entity
Mashhad University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 51 1846 1781
Email address
mirfeiziz@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Mashhad University of Medical Sciences and Health Services
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2011-06-20, 1390/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effects of Ginkgo biloba on ischemic manifestations of scleroderma in extremities
Public title
Therapeutic effects of Ginkgo biloba on ischemic manifestations of scleroderma in extremities
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: suffering from scleroderma, suffering from Raynaud's phenomenon, primary level of education, age more than 18 and less than 50 years old, signing the informed consent
Exclusion criteria: consumption of use anticoagulants, consumption of NSAIDs, consumption of mono amino Oxidase inhibitors
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences and Health Services
Street address
Ghoreishi Building, Daneshgah St, PO Box:951
City
Mashhad
Postal code
Approval date
2009-01-28, 1387/11/09
Ethics committee reference number
87176
Health conditions studied
1
Description of health condition studied
Scleroderma
ICD-10 code
M34
ICD-10 code description
Progressive Systemic Sclerosis
Primary outcomes
1
Description
Stiffness of the skin
Timepoint
Every months till 3 month
Method of measurement
Modified Rodnan Skin Score
2
Description
Raynaud's Condition
Timepoint
before treatment and at the end of months 1 , 2 , 3
Method of measurement
Raynaud's Condition Score
Secondary outcomes
1
Description
Interval of Raynaud's attack
Timepoint
every month till 3 month
Method of measurement
Patient examination and his/her statement about the condition of his/ her sickness.
Intervention groups
1
Description
Ginkgo biloba, Oral Tab 40 mg, Tds , for 3 months
Category
Treatment - Drugs
2
Description
Placebo, Oral Tab , Tds , for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Mashhad University of Medical Sciences and Health Services
Full name of responsible person
Vice President for Research (Jalil Tavakol Afshari Ph.D.)
Street address
Ghoreishi Building, Daneshgah St, PO Box:951
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Mashhad University of Medical Sciences and Health Services
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
Mashhad University of Medical Sciences and Health Services
Full name of responsible person
Mohamad Hassan Jokar
Position
Associated Professor/Sub-specialty in Rheumatology
Other areas of specialty/work
Street address
Ghoreishi Building, Daneshgah St, PO Box:951
City
Mashhad
Postal code
Phone
+98 51 1859 5818
Fax
Email
jokarmh@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences and Health Services
Full name of responsible person
Mohamad Hassan Jokar
Position
Associate Professor/Sub-specialty in Rheumatology
Other areas of specialty/work
Street address
Ghoreishi Building, Daneshgah St, PO Box:951
City
Mashhad
Postal code
Phone
+98 51 1859 5818
Fax
Email
jokarmh@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences and Health Services
Full name of responsible person
Seideh Zahra Mirfeizi
Position
Assistant Professor/Sub-specialty in Rheumatology
Other areas of specialty/work
Street address
Ghoreishi Building, Daneshgah St, PO Box:951
City
Mashhad
Postal code
Phone
Fax
Email
mirfeiziz@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)