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IRCT20110226005914N3 IRCT 2019-02-19 Oroumia University of Medical Sciences Effects of melatonin on depression and cognition function in hemodialyzed patients, A randomized, double-blind, controlled trial Effects of melatonin on depression and cognition function in hemodialyzed patients, A randomized, double-blind, controlled trial 2018-03-21 anticipated 50 Complete https://irct.ir/trial/31426 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocked randomization will be performed using a random number table generated by a computer software program and participants will be allocated to intervention or placebo group randomly. Also, the medicine and the placebo Packages are based on code. Another person who is unaware of the randomization and is not involved in the intervention, according to the code on the package, delivers the drugs to the patients.This randomization and assignment remain hidden from researchers and participants until the completion of the study, Blinding description: Blocked randomization will be performed using a random number table generated by a computer software program and participants will be allocated to intervention or placebo group randomly. Also, the medicine and the placebo Packages are based on code. Another person who is unaware of the randomization and is not involved in the intervention, according to the code on the package, delivers the drugs to the patients.This randomization and assignment remain hidden from researchers and participants until the completion of the study. 2 Chronic kidney disease, Hemodialysis. Intervention 1: Intervention group: Patients in the intervention group receive melatonin at a dose of 3 mg per day for two months. Intervention 2: Control group:In the control group, patients are given a placebo with no markings, with the same color, shape, packaging, size, odor, and taste, are given at the same dose as melatonin for the same duration. No - There is not a plan to make this available Justification or reason for not sharing IPD is Not familiar with the procedure
public Shima Hatamkhani
Emergency Alley, Resalat street
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3223 4897 hatamkhani@razi.tums.ac.ir Oroumia University of Medical Sciences scientific Shima Hatamkhani
Emergency Ave, Resalat Blvd, urmia
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3223 4897 hatamkhani@razi.tums.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) They should be hemodialized for at least 3 months and 3 times per week and 4 hours per visit. They should be fluent in Farsi language . They should have visual and auditory health to complete the questionnaire. 14 years 70 years Both Have diabetes type 1 or 2. Have psychotic disease Take antidepressant medicationss. Take anti-anxiety/sedative medications. N18.5 Chronic kidney disease, stage 5 Treatment - Drugs Treatment - Drugs Intervention group: Patients in the intervention group receive melatonin at a dose of 3 mg per day for two months. Control group:In the control group, patients are given a placebo with no markings, with the same color, shape, packaging, size, odor, and taste, are given at the same dose as melatonin for the same duration Depression Score in the Beck Questionnaire.Cognitive impairment Score in the MMSE Questionnaire. Timepoint: Before starting the medication and two months after taking Melatonin tablets. Method of measurement: Beck Depression questionnare and MMSE Cognitive Impairment questionnaire. Oroumia University of Medical Sciences Approved 2017-12-11 Ethics committee of Urmia University of Medical Sciences Emergency Alley, Resalat street Urmia West Azarbaijan Iran (Islamic Republic of)