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IRCT20200426047206N4 IRCT 2020-11-01 Hamedan University of Medical Sciences Effect of Melatonin in treatment of COVID-19 Evaluating the effect of Melatonin in prognosis and clinical improvement in patients with COVID-19: A Randomized Clinical Trial 2020-10-22 anticipated 60 Complete https://irct.ir/trial/51687 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, we will use the method of Balanced Block Randomization (block size: 4). For this purpose, we prepare four sheets of paper. On the two sheets, we write the I meaning "Intervention" and on the other two sheets we write the P meaning "Placebo". Mix the sheets together and place them in the desk drawer. When referring to any of the eligible patients, one of the sheets was randomly taken out, and based on this sheet, I or P was assigned to one of the two groups of intervention (melatonin recipient) or comparison (placebo recipient). They will be. Extracted tabs will not be returned to the drawer until all four tabs have been extracted. After randomly pulling out all four sheets, all the sheets are returned to the drawer and the above procedure will be continued for the next four patients until the desired sample size (60 patients) is reached, Blinding description: Both the intervention and control groups will receive drugs with the same appearance, the intervention group will receive melatonin in addition to the standard drugs, and the control group will receive standard drugs and placcebo. The drugs for each group are specified with a special code and the patient and the treating physician will be unaware of the type of drug used by the patients. Therefore, the study will be conducted in a double-blind manner. 3 Covid-19. Intervention 1: Intervention group: Melatonin supplement at a dose of 18 mg twice a day for 7 days and orally, with standard treatment. Intervention 2: Control group: They will receive the national standard treatment of Covid-19. 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 further information
public Salman Khazaei
Fahmideh street, Pajoohesh Blvd, Hamadan City
Hamedan Iran (Islamic Republic of) 6517838695 +98 81 3838 0548 salman.khazaei61@gmail.com Hamedan University of Medical Sciences scientific Salman Khazaei
Fahmideh street, Pajoohesh Blvd, Hamadan City
Hamedan Iran (Islamic Republic of) 6518325462 +98 81 3838 0548 salman.khazaei61@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age between 18-75 year Hospitalized in ward Confirmed diagnosis with PCR Elapsed less than 48 hour from symptom onset Not pregnant or breastfeeding Do not have moderate to severe liver and renal problems. Not treated with immunosuppressive drugs during the last 3 months 18 years 75 years Both Drug intolerance U07.1 covid-19 Treatment - Drugs Treatment - Drugs Intervention group: Melatonin supplement at a dose of 18 mg twice a day for 7 days and orally, with standard treatment Control group: They will receive the national standard treatment of Covid-19. The amount of hospitalization in the intensive care unit during 28 days. Timepoint: Day 28 after treatment. Method of measurement: view patients medical file. Need to oxygen therapy rate. Timepoint: During treatment. Method of measurement: view patients medical file. Rate of sleep and depression. Timepoint: Hospital Anxiety and Depression Questionnaire. Method of measurement: Score. Hamadan University of Medical Sciences Approved 2019-10-19 Ethics committee of Hamadan University of Medical Sciences Fahmideh Street Hamadan Hamadan Iran (Islamic Republic of)