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IRCT20200507047327N1 IRCT 2020-07-21 Shiraz University of Medical Sciences effect of curcumin on prevention of atrial fibrillation after coronary artery bypass graft surgery The effect of nano-curcumin on prevention of atrial fibrillation after coronary artery bypass graft surgery: a double-blind, randomized, placebo-controlled trial 2020-06-25 anticipated 200 Complete https://irct.ir/trial/49019 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, 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 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. 3 cardiac disease. Intervention 1: 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. Intervention 2: 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 ). Yes - There is a plan to make this available What will be shared: Clinical information of patients When: Start the access period 6 months after printing the results To whom: Researchers working in academic and scientific institutions Conditions: To use the information in your next studies Where to obtain: Samira Hossaini Alhashemi shossaini@sums.ac.ir How to obtain: The application is reviewed by the Shiraz University of Medical Sciences Security and may take up to 2 months Comments:
public Samira Hossaini Alhashemi
Shiraz school of pharmacy
Shiraz Iran (Islamic Republic of) ۷۱۴۶۸۶۴۶۸۵ +98 71 3242 5305 shossaini@sums.ac.ir Shiraz University of Medical Sciences scientific Samira Hossaini Alhashemi
Shiraz school of pharmacy
Shiraz Iran (Islamic Republic of) ۷۱۴۶۸۶۴۶۸۵ +98 71 3242 5303 shossaini@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients who are candidates for open heart surgery No history of cardiac surgery patients use ACE/ ARB, beta blocker, statin, ASA 18 years 82 years Both 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 I25.1 Atherosclerotic heart disease of native coronary artery Prevention Prevention 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. 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 ). Condition of Atrial fibrillation arrhythmia. Timepoint: five days after open heart surgery. Method of measurement: 24-hour monitoring of the patient by ECG. Shiraz University of Medical Sciences Approved 2020-04-08 Shiraz University of Medical Sciences Ethics Committee Shiraz school of pharmacy Shiraz Fars Iran (Islamic Republic of)