The aim of this study was to investigate the effect of curcumin on inflammatory and lipid profiles of patients with a history of acute coronary syndrome. The test will be started in the Baghiyatolah hospital Tehran, Iran and 80 patients will be evaluated that these patients will take 500 mg of curcumin capsules daily for 4 weeks.
Design
In this study, 80 patients with a history of acute coronary syndrome are studied and were divided into two groups that will take curcumin or placebo.
Settings and conduct
This study is done in the Heart disease center, Baqiyatolah hospital Tehran, Iran. Double blind randomized method
Participants/Inclusion and exclusion criteria
Patients referred to the Baghiyatollah hospital are selected using simple non-random sampling. Since curcumin has anticoagulant and diluent properties and is based on animal studies, it is likely that it will interfere with anticoagulants. Patients with the following conditions will not be included in the study: age over 75 years; use of anticoagulants and warfarin; peptic ulcer; history of bleeding, especially gastrointestinal bleeding; child bleeding; history of major surgery or recent trauma; heart failure.
Intervention groups
There are two intervention groups in this study: a group that receives 500 mg of curcumin and a group that receives placebo in the same form as curcumin capsules
Main outcome variables
Changes in hs-CRP and non-HDL cholestrole levels after 4 weeks of using curcumin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001165N39
Registration date:2019-04-24, 1398/02/04
Registration timing:registered_while_recruiting
Last update:2019-04-24, 1398/02/04
Update count:0
Registration date
2019-04-24, 1398/02/04
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-31, 1397/10/10
Expected recruitment end date
2019-04-30, 1398/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of curcumine on the inflammatory factors and lipid profile of patients with a history of acute coronary syndrome
Public title
Effect of curcumine (tumeric) on the inflammatory factors and lipid profile of patients with a history of acute coronary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with a history of acute coronary syndrome
Under the age of 75 y/o
Exclusion criteria:
Age over 75 years
Use of anticoagulants and warfarin
Peptic ulcer
History of bleeding, especially gastrointestinal bleeding
Child bleeding
History of major surgery or recent trauma
Severe heart failure
Age
From 12 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment to intervention and control groups; randomize using random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is done in double blind ways, in which both the researcher and the patient do not know if they received the drug or placebo. But it is explained to the patient who is participating in the study and may receive a drug or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran Islamic Azad University of Medical Sciences
Street address
Yakhchal street, Gholhak, Dr. Shariati ave.
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2018-10-14, 1397/07/22
Ethics committee reference number
IR.IAU.PS.REC.1397.276
Health conditions studied
1
Description of health condition studied
Acute coronary syndrome
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
Lipid profile changes
Timepoint
Baseline, 4 weeks after the start of the intervention
Method of measurement
Lab testing of lipid profile
Secondary outcomes
1
Description
decrease of inflammatory factors such as crp
Timepoint
Baseline, 4 weeks after the start of the intervention
Method of measurement
Lab testing of inflammatory factors such as CRP
Intervention groups
1
Description
Intervention group: pateints of the treatment group will recieve curcumin capsule (500 mg) every day after breakfast for 30 days
Category
Treatment - Drugs
2
Description
Control group: pateints of the treatment group will recieve placebo every day after breakfast for 30 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghiyyatollah University of Medical Sciences
Full name of responsible person
Yunes Panahi
Street address
Mollasadr Avn
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 2503
Email
Yunespanahi@bmsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr.amirhosein sahebkar
Street address
Mollasadra ave.
City
tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 2503
Email
Amir_saheb2000@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Yunes panahi
Position
clinical Pharmacy dr
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Mollasadra ave.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 2503
Email
Yunespanahi@bmsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Yunes Panahi
Position
clinical pharmacy dr
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Mollasadra Ave.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 2503
Email
Yunespanahi@bmsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zohre Mazhari
Position
pharmacy student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Yakhchal street, Gholhak, Dr. Shariati ave.
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21226400515
Email
mazhari_zohre@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information on the main consequence of the request and after review by the administrators is available for sharing
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Only available to scholars working in academic and academic institutions.
Under which criteria data/document could be used
not known until now
From where data/document is obtainable
dr yunes panahi in baghiyatollah hospital
What processes are involved for a request to access data/document
Submit a written request - Review by the principal responsible for studying and providing information