A total of 45 patients with rheumatoid arthritis who have been diagnosed with EULAR 2010 ACR criteria and 6 months of their illness are enrolled in the study.
Patients are examined at the beginning of the study and a questionnaire containing disease information is available. Height, weight, abdominal circumference, number of sensitive and swollen joints, and duration of disease and type of medication are recorded.
The disease activity is based on DAS28 and SDAI and
Before starting the administration of the patients, 5 ml of blood was taken after 8-10 hours of fasting and transferred to the glass tubes and after the creation of a clot and centrifuge with about 3000 RPM for 15 minutes, the serum would be isolated. Samples Serum will be transferred to the tubes forTBX2 measurement and will be transferred to the freezer -70 degrees
Then 80 mg of spray will be administered to the study group, which lasts for one week, and after the last administration, the sampling will be repeated under completely identical conditions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201707293812N6
Registration date:2017-08-08, 1396/05/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-08, 1396/05/17
Registrant information
Name
Amir Ghorbanihaghjo
Name of organization / entity
Biotechnology Research Center, Tabriz University of Medical Sciences, Tabriz 51664, Iran.
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 3234
Email address
ghorbani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Connective Tissue Disease Research Center. Tabriz University of Medical sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low dose aspirin on platelet inhibition in patients with rheumatoid arthritis
Public title
The effect of low dose aspirin on platelet inhibition in patients with rheumatoid arthritis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with rheumatoid arthritis who have been diagnosed with EULAR 2010 ACR criteria and have been ill for 6 months
Exclusion criteria:
Includes recent use of aspirin and anti-coagulant drugs, history of aspirin allergy, renal failure (creatinine above 8.1 mg / dL), thrombotic cytopenia, pregnancy, gastric ulcer and gastrointestinal bleeding. Patients with maternal and metabolic disorders are also among the exclusion criteria.
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz Univesity of Medical Sciences
Street address
Tabriz Univesity of Medical Sciences
City
Tabriz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.TBZMED.REC.1395.638
2
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences- Tabriz- Iran
City
Tabriz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.TBZMED.REC.1395.638
Health conditions studied
1
Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M06.9
ICD-10 code description
Rheumatoid arthritis, unspecified
2
Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M06.9
ICD-10 code description
Rheumatoid arthritis, unspecified
Primary outcomes
1
Description
platelet aggregation
Timepoint
One week
Method of measurement
Elisa
Secondary outcomes
1
Description
TXA2
Timepoint
one weak
Method of measurement
Elisa
2
Description
TX-A2
Timepoint
One week
Method of measurement
Elisa
Intervention groups
1
Description
Prescribing 80 mg of asprin on the patient's group and taking the drug for one week.After the last dose and re sampling, blood samples will be used to measure serum TX levels
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam reza Hospital - Tabriz University of Medical sciences
Full name of responsible person
Dr. Hajialilo
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Connective Tissue research Center- Tabriz University of Medical Sciences
Full name of responsible person
Dr Khabazi
Street address
Connective Tissue research Center- Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Connective Tissue research Center- Tabriz University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
abriz University of Medical Sciences, Tabriz, Iran
Full name of responsible person
Dr.Khabbazi
Street address
Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
abriz University of Medical Sciences, Tabriz, Iran
Proportion provided by this source
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
Amir ghorbanihaghjo
Position
Phd
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3336 4666
Fax
Email
ghorbaniamir@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of Medical Sciences
Full name of responsible person
Mahrzad Hajialilo
Position
rheumatologist
Other areas of specialty/work
Street address
Tabriz university of Medical Sciences
City
Tabriz
Postal code
Iran
Phone
+33 364666
Fax
Email
hajialilo@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Amir Ghorbanihaghjo
Position
PhD
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41133364666
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)