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IRCT20111119008129N14 IRCT 2023-08-01 Boushehr University of Medical Sciences Effects of melatonin on patients after coronary artery bypass surgery Melatonin administered postoperatively lowers oxidative stress and inflammation and significantly recovers heart function in patients undergoing CABG Surgery 2023-08-23 anticipated 60 Complete https://irct.ir/trial/70586 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 A and B represent the two intervention groups and C represents the control group. This method is performed by considering blocks of size 3 patients, so that the total number of 6 permutations is as follows: (A, B, C), (A, C, B), (B, A, C), (B, C, A), (C, A, B), (C, B, A). then, a number of 20 blocks will be randomly selected with replacement from these 6 block types. Finally, the desired list of 20 blocks of 3 (3 × 20 = 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 computerized sequence-numbered codes that are given to the subjects in opaque envelopes at their first visit. Both the clinical team and participants are blinded from the time of randomization until the analysis is completed, Blinding description: First, all melatonin and placebo capsules are prepared in the same shape and size and in packs of 60 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: Control group: The placebo group (250 mg neutral micro cellulose capsules) will be given half an hour before sleep, and all the tests including heart function, and blood sampling, will be exactly like the melatonin intervention group. It will be done before and after the study. Intervention 2: Intervention group: Melatonin (5 mg capsule) will be given once a night for half an hour before going to sleep, for 60 days. Intervention 3: Intervention group: This group will be given melatonin (10 mg capsules) once a night for half an hour before going to sleep for 60 days. 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 data and other documents of the study will be given to my colleagues at my University and other researchers and academic members from different universities worldwide. Conditions: If the researcher wants the document to use in the following research. The patients who want to know about the results of the examination Where to obtain: The main investigator responsible for the trial is to be referred for the results or any other documents. ِDr Ali Movahed, Biochemistry Laboratory, School of Medicine, Moallem ST, Bushehr.Mobile Number: 09173711063 How to obtain: The applicants should submit a request letter to the principal investigator, or a request from the deputy of research. Then, the request will be assessed by these authorities and the right files and documents will be submitted to the requester for a period of one or two weeks. Comments:
public Ali Movahed
Biochemistry Laboratory,School of Medicene,Moallem ST
Bushehr Iran (Islamic Republic of) 7514633341 +98 77 3332 4044 a.movahed@bpums.ac.ir Boushehr University of Medical Sciences scientific Ali Movahed
Biochemistry Laboratory, School of Medicine, BMoallem ST
Bushehr Iran (Islamic Republic of) 7514633341 +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 coronary artery bypass graft surgery Having no addiction to any drugs or alcohol Not having mental or psychological disorders Participants with the age between 30 to 70 years Absence of chronic diseases such as kidney, liver, digestive, bone diseases 30 years 70 years Both The patient's refusal to continue cooperation after a period of taking the intervention The presence of special conditions after the operation, for example, the patient being unconscious and not being able to take the intervention The occurrence of any problems related to surgery, such as heart attack, cardiac arrhythmia, bleeding at the surgical site, myocardial damage, etc., which causes the patient's condition to become unstable. Placebo Prevention Prevention Control group: The placebo group (250 mg neutral micro cellulose capsules) will be given half an hour before sleep, and all the tests including heart function, and blood sampling, will be exactly like the melatonin intervention group. It will be done before and after the study. Intervention group: Melatonin (5 mg capsule) will be given once a night for half an hour before going to sleep, for 60 days. Intervention group: This group will be given melatonin (10 mg capsules) once a night for half an hour before going to sleep for 60 days. The heart function. Timepoint: Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days). Method of measurement: By echocardiography. Diastolic blood pressure. Timepoint: Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days). Method of measurement: By sphygmomanometer, Mercury Type (Company: Microlife). Systolic blood pressure. Timepoint: Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days). Method of measurement: By sphygmomanometer, Mercury Type (Company: Microlife). CK-MB (creatine kinase MB). Timepoint: Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days). Method of measurement: By reliable kits (By using spectrophotometry). LDH (lactate dehydrogenase). Timepoint: Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days). Method of measurement: By reliable kits (By using spectrophotometry). TNF-α (tumor necrosis factor-α). Timepoint: Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days). Method of measurement: By ELISA technique. Hs-CRP (High-sensitivity C-reactive Protein). Timepoint: Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days). Method of measurement: By reliable kits (By using spectrophotometry). NO (Nitric oxide). Timepoint: Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days). Method of measurement: By ELISA technique. Total Antioxidant Capacity (TAC). Timepoint: Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days). Method of measurement: By ELISA technique. Malondialdehyde. Timepoint: Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days). Method of measurement: By reliable kits (By using spectrophotometry). Troponin T. Timepoint: Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days). Method of measurement: By ELISA technique. Alanine aminotransferase (ALT). Timepoint: Around 24 hours, before the start of melatonin consumption, and 24 to 72 hours after the period of 60 days of melatonin consumption. Method of measurement: By biochemistry auto analyzer- spectrophotometer. Aspartate aminotransferase (AST). Timepoint: Around 24 hours, before the start of melatonin consumption, and 24 to 72 hours after the period of 60 days of melatonin consumption. Method of measurement: By biochemistry auto analyzer- spectrophotometer. Alkaline phosphatase (ALP). Timepoint: Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(60 days) . Method of measurement: By biochemistry auto analyzer- spectrophotometer. Blood Urea Nitrogen. Timepoint: Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(60 days). Method of measurement: By biochemistry auto analyzer- spectrophotometer. Creatinine (Cr). Timepoint: Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(60 days). Method of measurement: By biochemistry auto analyzer- spectrophotometer. Low density lipids (LDL). Timepoint: Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(60 days). Method of measurement: By biochemistry auto analyzer- spectrophotometer. High density lipid (HDL). Timepoint: Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(60 days). Method of measurement: By biochemistry auto analyzer- spectrophotometer. Cholesterol. Timepoint: Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(60 days). Method of measurement: By biochemistry auto analyzer- spectrophotometer. Triglyceride (TG). Timepoint: Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(60 days). Method of measurement: By biochemistry auto analyzer- spectrophotometer. Bushehr University of Medical Sciences Approved 2023-05-08 Bushehr University of Medical Sciences Moallem Street, Bushehr Medical University Bushehr Boushehr Iran (Islamic Republic of)