]>
IRCT20190120042430N1 IRCT 2019-03-11 Oroumia University of Medical Sciences Evaluation of melatonin effects on oxidative stress in hemodialysied patiant Evaluation of melatonin effects on oxidative stress in hemodialysied patiant, A prospective,randomizized, double-blind, controlled trial 2017-11-22 anticipated 32 Complete https://irct.ir/trial/36970 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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, Blinding description: 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. 2-3 Chronic renal patients undergoing hemodialysis. Intervention 1: Intervent Patients in the intervention group melatonin or 5-hydroxy trriptamin with a dose of 3 mg daily for I and received orally .Melatonin pill-shaped building was purchased from the company natermade . Intervention 2: Control group: placebo in the control group as well as to patients without markings, packaging, shape, color, size, smell and taste the same in the same dose with melatonin was given the same term and patients under the care of routine. 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 There is no information.
public Zahra Rezai
Vakili Street, Bahonar Highway, Urmia
Urmia Iran (Islamic Republic of) 5851945858 +98 44 3672 8966 d.z73rezai@gmail.com Oroumia University of Medical Sciences scientific Zahra Rezai
Sero road, Urmia Univercity of Medical Sience
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3672 8966 d.z73rezai@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Patients should be at least two months before the start of the study are under dialysis Patients should not have smoking Principles of dialysis and dialysis person, long-term drug therapy during the study needs to be fixed. 15 years 75 years Both The patient during the study to undergo the surgery pregnancy or breast-feeding during the study Z49 Encounter for care involving renal dialysis Treatment - Drugs Placebo Intervent Patients in the intervention group melatonin or 5-hydroxy trriptamin with a dose of 3 mg daily for I and received orally .Melatonin pill-shaped building was purchased from the company natermade . Control group: placebo in the control group as well as to patients without markings, packaging, shape, color, size, smell and taste the same in the same dose with melatonin was given the same term and patients under the care of routine. Serum Glutathione. Timepoint: At the first of the study,30 and 60 days after start of melatonin. Method of measurement: eastbiopharm Lab kit. Superoxiddismutase. Timepoint: At the first of study, 30 and 60 dayse after start of melatonin. Method of measurement: Nasdox Lab kit of navande salamat. Oroumia University of Medical Sciences Approved 2016-11-25 Ethics committee of Urmia University of Medical Sciences Urmia University of Medical Sciences, sero road, Urmia Urmia West Azarbaijan Iran (Islamic Republic of)