Protocol summary
-
Study aim
-
The determination of lipid profile including total cholesterol, triglycerides, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) and inflammatory factors including Interleukin 1 beta(IL-1), high-sensitivity C-reactive protein (hs-CRP), Tumor necrosis factor alpha ( TNFα) and antioxidant factors including total antioxidant capacity(TAC), superoxide dismutase enzymes, glutathione peroxidase, and malondialdehyde concentration
-
Design
-
In this study, 90 coronary eligible patients undergoing stenting that referred to a special cardiology clinic of Golestan Hospital in Ahvaz were chosen. Participants are randomly assigned to three intervention and control groups and each participant is assigned a code.
-
Settings and conduct
-
This study is a randomized double-blind clinical trial. Cardiac patients undergoing coronary angioplasty and refer to the cardiology and cardiology clinic of Ahvaz Golestan Hospital are enrolled by a specialist heart consultant for this study. Then, 90 coronary patients were selected and randomly divided into three intervention and control groups. In this study, the investigator and the patient will be blinded to drugs and placebo.
-
Participants/Inclusion and exclusion criteria
-
Men and women with coronary artery stenosis who are willing to participate in the study.
-
Intervention groups
-
First intervention group: the group receiving nanomicell curcumin (80 mg daily)
Second intervention group: the group receiving Curcumin (80 mg daily)
Control group: placebo group
-
Main outcome variables
-
Lipid profile, Inflammatory factors, Antioxidant indices
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20141025019669N6
Registration date:
2017-12-17, 1396/09/26
Registration timing:
prospective
Last update:
2017-12-17, 1396/09/26
Update count:
1
-
Registration date
-
2017-12-17, 1396/09/26
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2017-12-21, 1396/09/30
-
Expected recruitment end date
-
2018-03-19, 1396/12/28
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
The survey of oral intake effect of nano micelles curcumin on lipid profile ، inflammatory markers and stress oxidative factors in patients undergoing the coronary elective angioplasty; a placebo-controlled randomized clinical trial double-blind.
-
Public title
-
Survey of effect of curcumin in coronary patients
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
All patients undergoing the coronary elective angioplasty.
Exclusion criteria:
Patients with coronary problems in last month
Patients with liver, gastrointestinal disorders and inflammatory diseases
-
Age
-
No age limit
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
-
Sample size
-
Target sample size:
90
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Simple randomization
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Patients of both sexes are randomly divided into four groups, intervention and control groups, using randomized distribution method. In this study, the patient and researcher are blinded to medicine and placebo.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2017-07-08, 1396/04/17
-
Ethics committee reference number
-
Ir.ajums.rec.1396.0638
Health conditions studied
1
-
Description of health condition studied
-
Cardiovascular disease
-
ICD-10 code
-
I51.6
-
ICD-10 code description
-
Cardiovascular disease
Primary outcomes
1
-
Description
-
Lipid profile
-
Timepoint
-
Before the intervention and after the intervention
-
Method of measurement
-
Eliza
2
-
Description
-
Inflammatory factors
-
Timepoint
-
Before the intervention and after the intervention
-
Method of measurement
-
Eliza
Secondary outcomes
1
-
Description
-
Antioxidant indices
-
Timepoint
-
Before intervention and after intervention
-
Method of measurement
-
Eliza
2
-
Description
-
Malondialdehyde concentration
-
Timepoint
-
Before intervention and after intervention
-
Method of measurement
-
Eliza
Intervention groups
1
-
Description
-
First intervention group: nanomicell curcumin, daily 80 mg
-
Category
-
Treatment - Drugs
2
-
Description
-
Second intervention group: Curcumin, daily 80 mg
-
Category
-
Treatment - Drugs
3
-
Description
-
Control group: Plasebo
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Ahvaz University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is a plan to make this available
-
Study Protocol
-
Yes - There is a plan to make this available
-
Statistical Analysis Plan
-
Yes - There is a plan to make this available
-
Informed Consent Form
-
Yes - There is a plan to make this available
-
Clinical Study Report
-
Yes - There is a plan to make this available
-
Analytic Code
-
Yes - There is a plan to make this available
-
Data Dictionary
-
Yes - There is a plan to make this available
-
Title and more details about the data/document
-
Data on primary and secondary outcomes will be published.
-
When the data will become available and for how long
-
After completing the study and analyzing the data
-
To whom data/document is available
-
All researchers
-
Under which criteria data/document could be used
-
There is no objection to the use of data provided the source of the resource.
-
From where data/document is obtainable
-
IRCT site
-
What processes are involved for a request to access data/document
-
Six months after the study
-
Comments
-