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IRCT20120520009801N4 IRCT 2020-12-15 Mashhad University of Medical Sciences Evaluation of the effect of crocin on prevention of atrial fibrillation after heart surgery Evaluation of the effect of crocin on prevention of atrial fibrillation after coronary artery bypass grafting (CABG) or valve replacement: a triple-blind, randomized, placebo-controlled trial 2020-11-21 anticipated 80 Complete https://irct.ir/trial/52391 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Alternate block randomization using www.randomization.com. Each block has 4 members and The aforementioned site selects twenty blocks out of quadruple blocks at random so that finally 80 patients can be included in the study. The allocation concealment method is also the use of opaque sealed envelopes with random sequences obtained from the random allocation step, Blinding description: After taking the drug or placebo for three days by the patient who has been kept blind to the use of the drug or placebo, the patient is introduced to a nurse in the hospital and the medication is prescribed by the nurse (therapist). In addition, the evaluator (physician) who is different from the therapist (nurse) and does not know which drug the patient has received and is aware only of the assigned code, performs the relevant evaluations. After registration, the results are given to the person who performs the data analysis in the form of a code, and the data analysis is performed without the knowledge of the data analyzer, and all confidential information is recorded and stored without mentioning the patient's name. 2 Atrial fibrillation after heart surgery. Intervention 1: Intervention group: It includes patients who receive 15 mg crocin tablets made by Sami Saz under the brand name Krocina twice a day for three days before to three days after surgery. The drug is taken by the patient himself and at home during the three days before the surgery and during the three days after the surgery by the nurses working in the intensive care unit. Intervention 2: Control group: It includes patients who receive a placebo twice a day, three days before to three days after surgery, which has been prepared in the Pharmaceutics Laboratory of Mashhad School of Pharmacy. The drug is taken by the patient himself and at home during the three days before the surgery and during the three days after the surgery by the nurses working in the intensive care unit. Yes - There is a plan to make this available What will be shared: all collected deidentified IPD When: starting 6 months after publication To whom: only available for people working in academic institutions Conditions: only available for people working in academic institutions and there is not another condition Where to obtain: mohamadpoorah@mums.ac.ir How to obtain: mohamadpoorah@mums.ac.ir Comments:
public Amir Hooshang Mohammadpour
School of Pharmacy, Mashhad University of Medical Sciences
Mashhad Iran (Islamic Republic of) 6519472972 +98 51 1882 3255 mohamadpoorah@mums.ac.ir Mashhad University of Medical Sciences scientific Amir Hooshang Mohammadpour
School of Pharmacy, Mashhad University of Medical Sciences
Mashhad Iran (Islamic Republic of) 6519472972 +98 51 1882 3255 mohamadpoorah@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Candidates for heart surgery including CABG or valve replacement 70 yr > age > 18 yr Taking ACEIs/ARBs, beta-blockers, statins and aspirin for CABG patients 18 years 70 years Both Have pacemaker Renal failure (45 ≥ GFR) Hepatic failure (hepatic enzymes > 3 times of upper normal limit ) Sensitivity to crocin or saffron History of taking anti-inflammatory or anti-oxidant drugs via two weeks before surgery Thyroid dysfunction Have AF rhythm History of heart surgery Pregnancy and lactation I48.0 Paroxysmal atrial fibrillation Prevention Prevention Intervention group: It includes patients who receive 15 mg crocin tablets made by Sami Saz under the brand name Krocina twice a day for three days before to three days after surgery. The drug is taken by the patient himself and at home during the three days before the surgery and during the three days after the surgery by the nurses working in the intensive care unit. Control group: It includes patients who receive a placebo twice a day, three days before to three days after surgery, which has been prepared in the Pharmaceutics Laboratory of Mashhad School of Pharmacy. The drug is taken by the patient himself and at home during the three days before the surgery and during the three days after the surgery by the nurses working in the intensive care unit. The incidence of atrial fibrillation. Timepoint: Through 72 hrs after heart surgery. Method of measurement: Holter monitoring. Hs-CRP blood concentration. Timepoint: Before surgery and 3 days after surgery. Method of measurement: Laboratory. Oxidative stress. Timepoint: Before surgery and 3 days after surgery. Method of measurement: Laboratory - malondialdehyde assay. The incidence of ventricular and supra-ventricular arrhythmias. Timepoint: Through 72 hrs after heart surgery. Method of measurement: Holter monitoring. Lenght of hospital stay. Timepoint: From heart surgery to discharge. Method of measurement: Counting of hospitalizations days. Mashhad University of Medical Sciences Approved 2020-10-26 Mashhad University of Medical Sciences Ethic committee of Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)