Randomized double blind placebo control trial; phase 2. Inclusion criteria: age more than 18 and diagnosis of coronary artery disease according to angiography results. Exclusion criteria: severe renal or hepatic failure; having infectious disease; use of immunosuppressive or anti-inflammatory drugs; curcumin sensitivity; pregnancy and lactation. The main goal of study is the evaluation of Curcumin effect on plaque formation and plaque rupturing biomarkers in coronary artery disease. 40 patients with the diagnosis of coronary artery diseases according to angiography results will be selected. These patients with completion of inclusion and exclusion criteria will be randomly included in one of two groups (curcumin or placebo) and will be treated with Curcumin or placebo in addition to typical therapeutic regimen. Blood samples will be prepared before and 2 months after the beginning of study and then evaluated for the effect on atherosclerosis plaque formation and plaque instability. Biomarkers including: MCP-1, VCAM-1, MMP-9, IL-18, CD-40L, MPO.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112028276N1
Registration date:2011-12-08, 1390/09/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-08, 1390/09/17
Registrant information
Name
Parastoo Mirzabeygi
Name of organization / entity
Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
pmirzabeygi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-12-08, 1390/09/17
Expected recruitment end date
2012-12-20, 1391/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Curcumin effect on plaque formation and plaque rupturing biomarkers in coronary artery disease
Public title
Curcumin effect on athresclerosis plaqua in coronary artery disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age more than 18 and diagnosis of coronary artery disease according to angiography results
Exclusion criteria: severe renal or hepatic failure; having infectious disease; use of immunosuppressive or anti inalmmatory drugs; curcumin sensitivity; pregnancy and lactation.
Age
From 18 years old
Gender
Both
Phase
2
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
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Pharmaceutical sciences research center Tehran University of Medical Sciences
Street address
School of pharmacy, Tehran university of medical sciences, Enghelab ave.
City
Tehran
Postal code
Approval date
2011-10-25, 1390/08/03
Ethics committee reference number
90-8-3:0-1
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
IL-18
Timepoint
Before and 2 month after begining of study
Method of measurement
Kit
2
Description
CD40L
Timepoint
Before and 2 month after begining of study
Method of measurement
Kit
3
Description
MMP-9
Timepoint
Before and 2 month after begining of study
Method of measurement
Kit
4
Description
MPO
Timepoint
Before and 2 month after begining of study
Method of measurement
Kit
5
Description
VCAM-1
Timepoint
Before and 2 month after begining of study
Method of measurement
Kit
6
Description
MCP-1
Timepoint
Before and 2 month after begining of study
Method of measurement
Kit
Secondary outcomes
empty
Intervention groups
1
Description
Curcumin, Capsule 500 mg,1g/twice daily
Category
Treatment - Drugs
2
Description
Placebo, Capsule 500 mg, 1g/twice daily
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice-Chancellor for Research
Street address
Sixth floor, Tehran University of Medical Sciences, Ghods street, Keshavarz blv.
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
Dr.Mohammad reza Javadi
Position
Assistance professor
Other areas of specialty/work
Street address
Clinical pharmacy department, School of pharmacy, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 218881415558
Fax
+98 21888322028
Email
javadirctex1351@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Pharmacy, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Amir Hooshang Mohammadpour
Position
Associate Professor
Other areas of specialty/work
Street address
School of Pharmacy, Mashhad University of Medical Sciences
City
Mashhad
Postal code
Phone
+98 51 1882 3255
Fax
Email
mohamadpoorah@mums.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
Parastoo Mirzabeygi
Position
Resident of Clinical Pharmacy
Other areas of specialty/work
Street address
Clinical Pharmacy department,School of Pharmacy, Tehran University of Medical Sciences, Enghelab Ave
City
Tehran
Postal code
Phone
Fax
+98 21 6695 4709
Email
pmirzabeygi@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)