Evaluation of Curcumin anti-inflammatory effects on peripheral blood mononuclear cells in coronary artery disease and plaque stabilization serum level of CD40L
Curcumin (diferuloylmethane) is an active component of the spice turmeric and has been linked with anti-inflammatory and chemopreventive activities. The present hypothesis explained the involvement of anti-inflammatory effects of crcumin in prevention of acute coronary syndromes (ACS) (i.e. unstable angina and myocardial infarction). ACS is the leading cause of death in both developed and developing countries. Coronary events often result from thrombi that form because of physical disruption of the atherosclerotic plaque. However, despite lipid lowing therapy with statins, significant numbers of cardiovascular events continue to occur indicating the need for additional agents for atherosclerosis management. We proposed that curcumin therapy can stabilize vulnerable 'rupture-prone' plaques by normalizing plaque properties. Thus, co-administration of curcumin along with other present options may prove to be a useful and potent natural plaque stabilizing approach in the prevention of ACS.
In this interventional study,the patients with less than 50% coronary obstruction and have medical follow up indication will be divieded in two two groups and curcumin and placebo.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013081114330N1
Registration date:2013-08-30, 1392/06/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-08-30, 1392/06/08
Registrant information
Name
Hamid Reza Rahimi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1800 2288
Email address
rahimihr891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2013-09-21, 1392/06/30
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Curcumin anti-inflammatory effects on peripheral blood mononuclear cells in coronary artery disease and plaque stabilization serum level of CD40L
Public title
Turmeric extract for the prevention of MI
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria: diagnosis of CAD; age above 18-75 years old; giving informed consent. Exclusion criteria: diabetes (assessed by measuring 126 <FBS); renal failure (with BUN, Cr); liver failure (evaluation of liver enzymes ALT, AST and bilirubin); drugs inhibit the immune system; taking pentoxifylline; taking cilostazol; an underlying infectious or inflammatory diseases (based on history and physical examination); having a history of sensitivity to curcumin (turmeric); high CRP (CRP) and Schiff Lvkvstvz the right (at least two positive CRP test qualitative biochemistry and CBC); taking glucosamine (due to inhibitory effects on the inflammatory NFκB); Egypt barberry extract, berberine (due to inhibitory effects on the inflammatory NFκB) and having a history of abuse syndromes induced absorption (based on history).
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
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
Street address
Faculty of Medicine, Azadi Square, Pardis Campus, Mashhad-Iran
City
Mashhad
Postal code
Approval date
2013-03-02, 1391/12/12
Ethics committee reference number
910738
Health conditions studied
1
Description of health condition studied
CAD
ICD-10 code
I25
ICD-10 code description
Chronic ischaemic heart disease
Primary outcomes
1
Description
Effect of curcumin on the expression of cellular markers of inflammation (NFκB)
Timepoint
Before and after study
Method of measurement
Gene expression and proteomics
Secondary outcomes
1
Description
plaque instability indirect parameters such as MMP9, CD40 concentration, and etc
Timepoint
Before the study and after stud
Method of measurement
Measurement of CD40L
Intervention groups
1
Description
The intervention group received routine treatment of heart disease in accordance with, the administration of curcumin. 1 Soft gel ((SinaCurcumin® (as nano-micelle 80 mg/day)) will be gave to patients for three months.
Category
Treatment - Drugs
2
Description
control group: in this group, the patients with less than 50% obstruction in coronary artery and have medical follow up will take their medications and placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital in Mashhad
Full name of responsible person
dr Mostafa Dastani
Street address
Mashhad, Ghaem Hospital, Ahmadabad Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences,vice chancellor for research
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Quraish bilding of MUMS, daneshghah St, Mashhad, Iran
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences,vice chancellor for research
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
Full name of responsible person
Hamid Reza Rahimi
Position
MD, PhD Student
Other areas of specialty/work
Street address
Faculty of Medicine, Azadi Square, Pardis Campus, Mashhad-Iran,
City
Mashhad
Postal code
Phone
+98 51 1800 2301
Fax
Email
rahimihr89+1@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Reza Kazemi Oskuee & Dr Amir Houshang Mohammadpour
Position
Assistant Prof
Other areas of specialty/work
Street address
Faculty of Medicine, Azadi Square, Pardis Campus, Mashhad-Iran,
City
Mashhad
Postal code
Phone
+98 51 1800 2288
Fax
Email
OskueeKR@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Reza Rahimi
Position
MD, PhD student
Other areas of specialty/work
Street address
Faculty of Medicine, Azadi Square, Pardis Campus, Mashhad-Iran
City
Mashhad
Postal code
Phone
+98 51 1800 2301
Fax
+98 511800287
Email
rahimihr891@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)