The aim of this study is evaluation of effect of Curcumin on serum levels of inflammatory markers in patients with acute myocardial infarction. Study is designed as Randomized, double-blind trial. Examples include patients referred to 22 Bahaman Hospital in Neyshabur city, disease has been confirmed by clinical signs, electrocardiogram and serum markers. 80 patients( 18-75 years) are selected and will be divided into two groups of intervention with curcumin and placebo. The main criteria inclusion are included: Diagnosis of Acute MI and exclusion criteria are: diabetes, kidney failure and liver failure. Patients were randomly divided into two equal groups. intervention are performed for 2 months, treated with a single dose of 500 mg per day curcumin or placebo. At the beginning and end of the study, blood levels of inflammatory markers will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017010922381N3
Registration date:2017-02-08, 1395/11/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-02-08, 1395/11/20
Registrant information
Name
Azam Rezaei Farimani
Name of organization / entity
Neyshabur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4334 4011
Email address
rezaia1@nums.ac.ir
Recruitment status
Recruitment complete
Funding source
Neyshabur University of Medical Sciences in collaboration with Mashhad, Razavi Hospital
Expected recruitment start date
2017-02-18, 1395/11/30
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of curcumin on serum levels of inflammatory markers in patients with acute myocardial infarction
Public title
The effect of curcumin in the treatment of patients with acute myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
diagnosed Acute MI based on clinical signs, electrocardiogram and serum markers; older than 18 years; maximum age of 75 years; written consent form.
Exclusion criteria:
Diabetes; renal failure; liver failure; immunosuppressive drugs; pentoxifylline; cilostazol consumption; inflammatory diseases; sensitivity of curcumin (turmeric); leukocytosis with a left Schiff; the use of glucosamine. Barberry juice consumption; malabsorption disorders; history of clotting problems; history of consumption anticoagulant therapy; patients with surgical indications.
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:
80
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
Neyshabour University of Medical Science
Street address
Office of Research Affairs, Razi St, ShahidJafari St, Imam Khomeini Square, Neyshabur, Iran
City
Neyshabour
Postal code
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.NUMS.REC.1394.15
Health conditions studied
1
Description of health condition studied
Acute Myocardial Infarction
ICD-10 code
121
ICD-10 code description
myocardial infarction specified as acute or with a stated duration of 4 weeks (28 days) or less from onset
Primary outcomes
1
Description
MCP-1
Timepoint
Before intervention and two months after intervention
Method of measurement
pg / ml using blood tests
2
Description
IL-2
Timepoint
Before intervention and two months after intervention
Method of measurement
pg / ml using blood tests
3
Description
IL-6
Timepoint
Before intervention and two months after intervention
Method of measurement
pg / ml using blood tests
4
Description
IL-8
Timepoint
Before intervention and two months after intervention
Method of measurement
pg / ml using blood tests
5
Description
IL-1α
Timepoint
Before intervention and two months after intervention
Method of measurement
pg / ml using blood tests
6
Description
IL-1β
Timepoint
Before intervention and two months after intervention
Method of measurement
pg / ml using blood tests
7
Description
VEGF
Timepoint
Before intervention and two months after intervention
Method of measurement
pg / ml using blood tests
8
Description
TNFα
Timepoint
Before intervention and two months after intervention
Method of measurement
pg / ml using blood tests
9
Description
EGF
Timepoint
Before intervention and two months after intervention
Method of measurement
pg / ml using blood tests
10
Description
INF-γ
Timepoint
Before intervention and two months after intervention
Method of measurement
pg / ml using blood tests
11
Description
IL-4
Timepoint
Before intervention and two months after intervention
Method of measurement
pg / ml using blood tests
12
Description
IL-10
Timepoint
Before intervention and two months after intervention
Method of measurement
pg / ml using blood tests
13
Description
Hs-CRP
Timepoint
Before intervention and two months after intervention
Method of measurement
Mg / dl using blood tests
14
Description
homosysteine
Timepoint
Before intervention and two months after intervention
Method of measurement
pg / ml using blood tests
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Curcumin, 500 mg capsules، single dose per day for 2 months, the chemical formula: C21H2O6
Category
Treatment - Drugs
2
Description
Control group: placebo, starch, 500 mg capsules، single dose per day for 2 months