Evaluation of melatonin effects on oxidative stress in hemodialysied patiant, A prospective,randomizized, double-blind, controlled trial

Prevention and treatment of oxidative stress in patients undergoing dialysis

Clinical trial has a group control, double blind, randomized, with 32 sample of phase 3 clinical trials.

In this study, the aim of community patients undergoing dialysis in dialysis section, referring toTaleghani hospital dialysis subjects under the direction of Urmia were enrolled in the study, a questionnaire that includes demographic information (age and sex), the history of the disease, history of drug use and smoking, were completed. Of the company's eligible applicants were fitted to request informed consent was prepared and signed study. Patients to assess blood samples were taken from biochemistry and the size of the testing decisions related to glutathione, catalase and SOD. Patients in the intervention group melatonin with 3 mg per day for 2 month. Patients in the control group as well as the placebo without markup, with colors, shapes, sizes, fitted, smell and taste the same in the same dose with melatonin was given the same term.

The terms of entry into the study. patients should be at least two months before the start of the study under dialysis.The terms of the withdrawal from the study patients.The patient throughout the surgery study

The patients in the intervention group get melatonin with 3mg per day for2 month. Patients in the control group as well as the placebo without markup, with colors, shapes, sizes, fitted, smell and taste the same in the same dose with melatonin was given the same term.

In this randomized, placebo controlled, melatonin levels of glutathione, catalase and SOD of chronic renal patients serum under dialysis significantly increases.

Melatonin and placebo that were identical in terms of appearance, each in a separate container A and B.A person who does not have a role in intervention storage between two random ¬ intervention and control in the form of block based on age and sex of the individual who conducted by computer, then had no role in the intervention and of the allocation of the container forklift was unprecedented, Type3, random sequence of news, drugs and packaging each package Based on a random list of medicinal created a code.He also lists the codes for the allocation of patients to treatment group.Random sequence until the end of the study in a safe place away from the register box maintenance.Another person who had no role in the intervention and of the infinite sequence of random ¬ news, participants on the basis of the list of codes assigned to the treatment group.This fitted and random allocation until the completion of the statistical analysis of the company's suppliers and loaders stayed hidden.

In this study, the following people are blind to treatment allocation: participants, the one who prescribed the medications, Lab staff, who collect laboratory data, and analyst data but the DSMB (data and safety monitoring Committee) of the type of information assigned intervention.Medications to placebo tablet form and in terms of shape, size, color, taste, smell and packaging similar to melatonin

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