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IRCT20130829014521N19 IRCT 2022-02-19 Mashhad University of Medical Sciences Effect of curcumin on preventing heart failure Evaluation of curcumin effect on preventing heart failure after myocardial infarction 2021-07-23 anticipated 40 Complete https://irct.ir/trial/59766 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be allocated to 500mg capsule of curcumin (500mg daily) or placebo capsule, by block randomization with block size of 2. In each block, patients of each group will be exist. The order of blocks will be determined randomly in 500mg capsule of curcumin (500mg daily) and placebo capsule groups and subjects will allocated sequentially with order of admitting. Random allocation rule method was used for determination of sequences. Using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed, Blinding description: Blinding will be done by complete matching of placebo and drugs by color, size, shape and smell. Patients receive drugs (intervention or placebo groups) in closed pockets which are coded and patients are not aware of their contents. Coding will be done by one of the colleagues of the study and evaluator nurse will be blind for type of drugs. 0 (exploratory trials) ST elevation myocardial infarction. Intervention 1: Intervention group: curcumin capsule 500 mg. Intervention 2: Control group: placebo capsule 500mg. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Raw data will be shared with applicants upon a valid and reasonable request.
public Amirhossein Sahebkar
Azadi Square
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1100 sahebkara@mums.ac.ir Mashhad University of Medical Sciences scientific Ramin Khameneh
Ghaem hospital, Mashhad city, IRan
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 1800 2288 khamenehR@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) ST elevation myocardial infarction Successful treatment with percutaneous coronary intervention (PCI) on related vessel to infarct 18 years 80 years Both Previous myocardial infarction lead to ejection fraction less than 50% malignant arrhythmia congenital heart disease cardiogenic shock history of suspicious or documented heart failure or decrease in left ventricular ejection fraction patients candidate for coronary artery bypass graft (CABG) or previous CABG patients with glomerular filtration rate lesser than 30 patients with history of autoimmune or connective tissue disorders patients with cancer pregnant or breastfeeding women patients with previous documented psychological disorders patients who can not complete their 2-month clinical followups during study BA41.0 BA41 Treatment - Drugs Placebo Intervention group: curcumin capsule 500 mg Control group: placebo capsule 500mg Left ventricular ejection fraction. Timepoint: baseline and 60 days later. Method of measurement: By echocardiography. Major adverse cardiovascular events. Timepoint: during hospitalization and 60 days after starting study. Method of measurement: documents and reports of cardiac death, recurrent MI, culprit vessels revascularisation, cardiogenic shock, severe heart failure, major arrhythmia. Mashhad University of Medical Sciences Approved 2019-04-17 Ethical Committee of Mashhad University of Medical Sciences Qoreshi Mashhad Razavi Khorasan Iran (Islamic Republic of)