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IRCT20111119008129N12 IRCT 2022-06-18 Boushehr University of Medical Sciences Protective role of Resveratrol in Heart surgery The protective Potential of resveratrol in the prevention and reduction of complications in patients undergoing elective coronary artery bypass grafting surgery 2022-06-20 anticipated 60 Complete https://irct.ir/trial/63793 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The random allocation method in this study will be permutated block randomization, where T represents the person receiving the intervention and C represents the person who receive the Placebo. This method is performed by considering blocks of sizes 4 patients so that the total number of 4 permutations is equal to 6 blocks as follows: (C,C,T,T), (T,T,C,C), (C,T,T,C), (C,T,C,T), (T,C,C,T), (T,C,T,C), (C,T,C,T) Then, a number of 15 blocks will be randomly selected with replacement from these 6 blocks. Finally, the desired list of 15 blocks of 4 (4 * 15 = 60 total number of samples) is generated and the order of assignment to each of the samples participating in the study is determined. These steps are performed using R software version 3.6.3, Blinding description: First, all resveratrol and placebo capsules are prepared in the same shape and size and in packs of 20 for distribution to patients. The resveratrol and placebo packages are then labeled based on computer-generated codes (without indication of its content). Each of these codes is determined based on the sequence of random allocation of individuals to groups. The project manager, the only person who is aware of the codes and the order in which individuals are assigned to groups, is not involved in any of the evaluation and measurement of outcomes steps. On the other hand, the shape, size, and type of packaging of the resveratrol and placebo are exactly the same, so the patient and the outcome evaluator will not know the type of intervention. 3 Diseases of the circulatory system. Intervention 1: Intervention group: To this group will be given 250 mg capsules of Resveratrol ( 98% pure, AllNatural, Nutritional INC, Winnipeg, Canada). two times a day, morning and evening for a period of 60 days. Intervention 2: Control group: To this group, will be given 250 mg capsules of totally inert -microcellulose, Biotivia, Bioceuticals International SrI, Italy) and the routine medicines. And, all the examinations for heart function and blood examinations are done, exactly in the same way as the intervention group.Before and after the Trial. Yes - There is a plan to make this available What will be shared: The Deputy of Research is responsible to provide the information and documents to the participants in the Trial. When: After the trial was over and the results were analyzed, for a period of one year, access to the document is possible. To whom: The principal investigator, the participants undergone the trial, deputy of research and technology. Conditions: 1- If the researcher wants the document to use in the following research. 2- The patients who want to know about the results of the examination Where to obtain: The main investigator or responsible for the trial, or the deputy of Research should be contacted. How to obtain: A request letter to be given to the main investigator, or the Deputy of Research to be consider. Comments:
public Ali Movahed
Moallem ST, Faculty of Medicine, Biochemistry Laboratory, Bushehr Universirty Of Medical Sciences, Bushehr, Iran.
Bushehr Iran (Islamic Republic of) 987514633341 +98 77 3332 4044 a.movahed@BPUMS.ac.ir Boushehr University of Medical Sciences scientific Ali Movahed
Moallem ST, Faculty of Medicine, Biochemistry Lab, Bushehr Universirty of Medical Sciences, Bushehr, Iran
Bushehr Iran (Islamic Republic of) 987514633341 +98 77 3332 4044 a.movahed@BPUMS.ac.ir Boushehr University of Medical Sciences Iran (Islamic Republic of) Intention of the patients to participate in the trial Patients on elective surgery Having no addiction to any drugs or alcohol Not having mental or psychological disorders Participants with the age between 30 to 70 years 30 years 70 years Both History of having chronic kidney disease, History of having chronic liver disease Having heart surgery before I24 Ischemic heart diseases Prevention Prevention Intervention group: To this group will be given 250 mg capsules of Resveratrol ( 98% pure, AllNatural, Nutritional INC, Winnipeg, Canada). two times a day, morning and evening for a period of 60 days. Control group: To this group, will be given 250 mg capsules of totally inert -microcellulose, Biotivia, Bioceuticals International SrI, Italy) and the routine medicines. And, all the examinations for heart function and blood examinations are done, exactly in the same way as the intervention group.Before and after the Trial. The heart function. Timepoint: Around 24 hours, before the start of Resveratrol consumption, and 12 to 24 hours after the period of 60 days of consumption. Method of measurement: By echocardiography. Diastolic blood pressure. Timepoint: Around 24 hours, before the start of Resveratrol consumption, and 12 to 24 hours after the period of 60 days of consumption. Method of measurement: By sphygmomanometer, Mercury Type ( Microlife company). Systolic blood pressure. Timepoint: Around 24 hours, before the start of Resveratrol consumption, and 12 to 24 hours after the period of 60 days of consumption. Method of measurement: By sphygmomanometer, Mercury Type ( Microlife company). Total Antioxidant Capacity( TAC). Timepoint: َAround 24 hours, before the start of Resveratrol consumption, and 24 to 72 hours after the period of 60 days of Resveratrol consumption. Method of measurement: By ELISA technique. LDH (lactate dehydrogenase). Timepoint: َAround 24 hours, before the start of Resveratrol consumption, and 24 to 72 hours after the period of 60 days of Resveratrol consumption. Method of measurement: By reliable kits( By using spectrophotometry). TBRS. Timepoint: َAround 24 hours, before the start of Resveratrol consumption, and 24 to 72 hours after the period of 60 days of Resveratrol consumption. Method of measurement: By ELISA technique. CK-MB (creatine kinase MB). Timepoint: َAround 24 hours, before the start of Resveratrol consumption, and 24 to 72 hours after the period of 60 days of Resveratrol consumption. Method of measurement: By reliable kits( By using spectrophotometry). NO (Nitric oxide). Timepoint: َAround 24 hours, before the start of Resveratrol consumption, and 24 to 72 hours after the period of 60 days of Resveratrol consumption. Method of measurement: By ELISA technique. TNF-α (tumor necrosis factor-α). Timepoint: َAround 24 hours, before the start of Resveratrol consumption, and 24 to 72 hours after the period of 60 days of Resveratrol consumption. Method of measurement: By ELISA technique. Hs-CRP (High-sensitivity C-reactive Protein). Timepoint: َAround 24 hours, before the start of Resveratrol consumption, and 24 to 72 hours after the period of 60 days of Resveratrol consumption. Method of measurement: By reliable kits( By using spectrophotometry). Boushehr University of Medical Sciences Approved 2022-04-25 Bushehr University of Medical Sciences, Bushehr, Iran Moallem Street, Bushehr Medical University Bushehr Boushehr Iran (Islamic Republic of)