The effect of nano-curcumin on prevention of atrial fibrillation after coronary artery bypass graft surgery: a double-blind, randomized, placebo-controlled trial
Prevention of atrial fibrillation after coronary artery bypass graft surgery and its adverse effect by curcumin
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 200 patients, simple randomization are used for randomization.
Settings and conduct
The study is being conducted in Shiraz and in Ordibehesht and Markazi hospitals. The intervention group included patients who candidate for open heart surgery and took 80 mg of curcumin-containing soft-gel nanomicell capsules three times a day for three days before surgery and four days after surgery with a standard medication regimen (including beta-blockers, statins, and aspirin, which patients had taken before surgery). they receive. The control group included patients who candidate for open heart surgery and receiving a placebo capsule three days before surgery and four days after surgery with a standard medication regimen. All patients are fully monitored for 120 hours after surgery
Participants/Inclusion and exclusion criteria
inclusion criteria:
Patients are candidates for open heart surgery
Have no history of heart surgery before surgery.
Get medications from ACE / ARB, beta-blockers, statins and aspirin
exclusion criteria:
Cardiac arrhythmias or taking antiarrhythmic drugs
use Digoxin
Heart valve disorders
Heart failure and EF ≤ 30%
Renal failure (creatinine ≥ 1.5)
Severe hepatic insufficiency (increased liver enzymes more than 3 times normal)
Sensitivity to turmeric
Intervention groups
give curcumin to intervention group and palcebo to control group
Main outcome variables
Condition of atrial fibrillation arrhythmia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200507047327N1
Registration date:2020-07-21, 1399/04/31
Registration timing:registered_while_recruiting
Last update:2020-07-21, 1399/04/31
Update count:0
Registration date
2020-07-21, 1399/04/31
Registrant information
Name
Samira Hossaini Alhashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3242 4127
Email address
shossaini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-25, 1399/04/05
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nano-curcumin on prevention of atrial fibrillation after coronary artery bypass graft surgery: a double-blind, randomized, placebo-controlled trial
Public title
effect of curcumin on prevention of atrial fibrillation after coronary artery bypass graft surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for open heart surgery
No history of cardiac surgery
patients use ACE/ ARB, beta blocker, statin, ASA
Exclusion criteria:
history of Cardiac arrhythmias or taking antiarrhythmic drugs
use digoxin
Heart valve disorders
Heart failure and EF ≤ 30%
Renal failure (creatinine ≥ 1.5)
Severe hepatic insufficiency (increased liver enzymes more than 3 times normal)
Sensitivity to turmeric
Age
From 18 years old to 82 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in the study are completely randomly divided into two groups of intervention and control. The method of randomization is simple, ie each participant is completely randomly assigned to one of two groups. In this way, patients receive numbers in the order that they attend the heart surgeon's office, and the odd numbers are in the control group and the even numbers are in the intervention group. Regarding the concealment of the study, it should be said that none of the participants knew about their assignment to the intervention and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Three groups of people are kept blind in this study. The first group are patients who participated in the study. These people have no information about their assignment to control or intervention groups, or the type of treatment (the main drug or placebo) . The second group of patient carers in this study also do not know about the allocation of patients to the intervention and control group and the type of treatment (the main drug or placebo).The third group analyzes the data, but they do not know the nature of the data, the type of groups and the type of treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences Ethics Committee
Street address
Shiraz school of pharmacy
City
Shiraz
Province
Fars
Postal code
۷۱۴۶۸۶۴۶۸۵
Approval date
2020-04-08, 1399/01/20
Ethics committee reference number
IR.SUMS.REC.1399.019
Health conditions studied
1
Description of health condition studied
cardiac disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Condition of Atrial fibrillation arrhythmia
Timepoint
five days after open heart surgery
Method of measurement
24-hour monitoring of the patient by ECG
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: took 80 mg of curcumin-containing soft-gel nanomicell capsules three times a day for three days before surgery and five days after surgery with a standard medication regimen (including beta-blockers, statins, and aspirin, which patients had taken before surgery). they receive.
Category
Prevention
2
Description
Control group: Patients who receive placebo capsules three days before surgery and five days after surgery with a standard medication regimen.The placebo capsule is exactly like the original medicine and soft gel, which contains olive oil and is made by the main drug manufacturer (Nano Elixir Sina ).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ordibehesht hospital
Full name of responsible person
Samira Hossaini Alhashemi
Street address
Chamran street
City
Shiraz
Province
Fars
Postal code
۷۱۴۶۸۶۴۶۸۵
Phone
+98 71 3242 5374
Email
shossaini@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shiraz University of Medical Sciences Vice Chancellor for research and technology affair
Street address
zand street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
shossaini@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Samira Hossaini Alhashemi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Shiraz school of pharmacy
City
Shiraz
Province
Fars
Postal code
۷۱۴۶۸۶۴۶۸۵
Phone
+98 71 3242 5305
Email
shossaini@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Samira Hossaini Alhashemi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Shiraz school of pharmacy
City
Shiraz
Province
Fars
Postal code
۷۱۴۶۸۶۴۶۸۵
Phone
+98 71 3242 5303
Email
shossaini@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Samira Hossaini Alhashemi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Shiraz school of pharmacy
City
Shiraz
Province
Fars
Postal code
۷۱۴۶۸۶۴۶۸۵
Phone
+98 71 3242 5303
Email
shossaini@sums.ac.ir
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
Undecided - It is not yet known if there will be 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
Clinical information of patients
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
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
To use the information in your next studies
From where data/document is obtainable
Samira Hossaini Alhashemi
shossaini@sums.ac.ir
What processes are involved for a request to access data/document
The application is reviewed by the Shiraz University of Medical Sciences Security and may take up to 2 months