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Effects of Turmeric (Curcumin) on inflammatory factors affecting Remodeling after acute ST-segment elevation myocardial infarction

Protocol summary

Summary
Objective: The aim of study is evaluation of effect of Turmeric (Curcumin) on inflammatory factors affecting Remodeling after acute myocardial infarction (ST-segment elevation myocardial infarction). Participants: The study population is patients with STEMI. Including criteria: All patients with acute myocardial infarction with ST-segment elevation myocardial infarction are included. Excluding criteria: Exclusion criteria are Acute or chronic infection, co-exciting autoimmune diseases such as connective tissue disorders, malignancy, surgery during one month ago, treatment with corticosteroids, immunosuppressants, thiazolidinediones, or NSAIDs, chronic liver disease, chronic renal disease. Intreventions: All patients divide to two groups: intervention and control. The sample size in each group is 30 patients. The intervention group will be given 750 mg curcumin orally for 4 weeks and the control group will receive placebo for the same period. Main outcome measures: At time of administration and the end of 4 weeks, cardiac biomarkers (CKMB, CTnT), serum levels of inflammatory markers (NT Pro-BNP, CRP, TNFα, IL1, IL6) will be measured. Also, patients will be evaluated for drug complications.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012112011235N1
Registration date: 2013-01-08, 1391/10/19
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-01-08, 1391/10/19
Registrant information
Name
Mohammad Javd Alemzadeh-Ansari
Name of organization / entity
Tehran Heart Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 916 617 4016
Email address
aansari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Baghiatallah Medical Sciences University
Expected recruitment start date
2013-01-09, 1391/10/20
Expected recruitment end date
2015-01-10, 1393/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Turmeric (Curcumin) on inflammatory factors affecting Remodeling after acute ST-segment elevation myocardial infarction
Public title
Effects of Turmeric on inflammatory factors affecting Remodeling after acute myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with ST-segment elevation myocardial infarction exclusion criteria: Acute or chronic infection; co-exciting autoimmune diseases such as connective tissue disorders; malignancy; surgery during one month ago; treatment with corticosteroids, immunosuppressants, thiazolidinediones, or NSAIDs; chronic liver disease; chronic renal disease (serum creatinine more than 3 mg/dl or glomerular filtration rate less than ml/min)
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical sciences
Street address
Mirdamad st, Tehran
City
Tehran
Postal code
Approval date
2012-10-31, 1391/08/10
Ethics committee reference number
Ethics committee of Baqiyatallah University of Medical sciences (meeting no: 31)

Health conditions studied

1

Description of health condition studied
Acute transmural myocardial infarction of unspecified site
ICD-10 code
I21.3
ICD-10 code description
Transmural myocardial infarction NOS

Primary outcomes

1

Description
CTnT
Timepoint
before intervention, 8 weeks later
Method of measurement
Laboratory Test (ng/L)

2

Description
CKMB
Timepoint
before intervention, 8 weeks later
Method of measurement
Laboratory Test (ng/ml)

3

Description
Interleukin 1
Timepoint
before intervention, 8 weeks later
Method of measurement
Laboratory Test (ng/ml)

4

Description
Interleukin 6
Timepoint
before intervention, 8 weeks later
Method of measurement
Laboratory Test (ng/ml)

5

Description
Tumor necrosis factor-alpha
Timepoint
before intervention, 8 weeks later
Method of measurement
Laboratory Test (ng/ml)

6

Description
N-terminal prohormone of brain natriuretic peptide
Timepoint
before intervention, 8 weeks later
Method of measurement
Laboratory Test (ng/ml)

7

Description
C-reactive protein
Timepoint
before intervention, 8 weeks later
Method of measurement
Laboratory Test (ng/ml)

Secondary outcomes

empty

Intervention groups

1

Description
Capsule placebo three times daily for 4 weeks
Category
Treatment - Drugs

2

Description
Curumin 250 mg orally three times daily (750 mg) for 4 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Heart Center Hospital
Full name of responsible person
Mohammad Javad Alemzadeh-Ansari
Street address
North Kargar-Ave
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Baqiyatallah University of Medical sciences
Full name of responsible person
Motreza Izadi
Street address
Mirdamad st, Tehran
City
Tehran
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, Baqiyatallah 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 Heart Center Hospital
Full name of responsible person
Mohammad Javad Alemzadeh-Ansari
Position
Resident of Cardiology
Other areas of specialty/work
Street address
North Kargar-Ave
City
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
+98 21 8802 9731
Email
mj.aansari@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Health Research Center , Baqiyatallah University of Medical Sciences
Full name of responsible person
Nematollah Jonaidi
Position
Associate Professor
Other areas of specialty/work
Street address
Molla Sadra ave.
City
Tehran
Postal code
Phone
+98 21 8248 2470
Fax
Email
jonaidi2000@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran Heart Center Hospital
Full name of responsible person
Mohammad Javad Alemzadeh-Ansari
Position
Resident of Cardiology
Other areas of specialty/work
Street address
North Kargar-Ave
City
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
Email
mj.aansari@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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