Melatonin administered postoperatively lowers oxidative stress and inflammation and significantly recovers heart function in patients undergoing CABG Surgery

Evaluation of effects of melatonin on heart function and inflammatory and oxidant biomarkers in patients after CABGS.

Clinical trial with a control group, with parallel groups, double-blind, phase 3 on 60 patients. R software version 3.6.3 was used for randomization

Patients undergoing CABG surgery at Bushehr Heart Center after discharge from the hospital will complete the consent form and questionnaire. Then 10cc blood sample will be collected from them after consuming melatonin and a placebo for a period of 60 days period of intervention. The project manager, the only person who knows about the codes and the order of assigning people to groups, is not involved in any of the stages of evaluating and measuring the results. On the other hand, the shape, size, and type of packaging of drugs and placebo are completely the same, so the patient and the outcome assessor will not know the type of intervention.

Inclusion criteria: Intention of the patients to participate in the trial, Having no addiction to any drugs or alcohol. Not having mental or psychological disorders. Absence of chronic diseases such as kidney, liver, digestive, and bone diseases. Exclusion criteria: Occurrence of any problems related to surgery, such as heart attack, cardiac arrhythmia, bleeding at the surgical site, myocardial damage, etc.,

The case group will be given melatonin (5 mg and 10 mg capsules, once a night for 60 days). The control group will be without melatonin

Heart Function, including: Ejection Fraction, Atrial fibrillation(AF), ECG, blood pressure( diastolic and Systolic).CK-MB enzyme, LDH enzyme, troponin T, total antioxidant capacity (TAC), malondialdehyde (MDA), TNF-a, hs - CRP, nitric oxide synthase (NO)

Title updated to be more appropriate Randomization method has been modified

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.

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.

The Deputy of Research is responsible to provide the information and documents to the participants in the Trial

After the trial was over and the results were analyzed, for a period of one year, access to the document is possible.

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.

If the researcher wants the document to use in the following research. The patients who want to know about the results of the examination

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

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.