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IRCT20200922048804N1 IRCT 2020-10-06 Tehran University of Medical Sciences Melatonin in COVID-19 CEM Inflammation control in patients with COVID-19 using melatonin supplement compare to controls referred to Imam Khomani Hospital 2020-08-05 anticipated 20 Complete https://irct.ir/trial/51177 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Blinding description: In this project, the participant is explained about participating in the project and informed consent is obtained. Also, the physician who is in contact with the patient is aware of the intervention groups and is responsible for following up on the participants.Researcher and data analyst are blind. N/A COVID-19. Intervention 1: Intervention group: Prescribing 6 mg of melatonin capsules made by Elite factory for 2 weeks, which should be consumed half an hour before bedtime every night in low light conditions and even sleep in light conditions. These explanations were described to each patient. Melatonin is a hormonal supplement used to regulate sleep. Patients (if needed) receive medication prescribed by the doctor (hydroxychloroquine, acetaminophen, naproxen). Intervention 2: Control group: Patients (if needed) receive medication prescribed by the doctor (hydroxychloroquine, acetaminophen, naproxen). Yes - There is a plan to make this available What will be shared: Information about the main outcome can be shared. When: Access will start after printing the results. To whom: The data will be available to researchers working in academic and scientific institutions. Conditions: Data access is possible upon formal request. Where to obtain: Zahra Alizadeh zalizade@yahoo.com How to obtain: Send a formal request by email. Comments:
public Zahra Alizadeh
Dr. Gharib St.
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6693 5855 zalizade@yahoo.com Immunology, Asthma & Allergy Research Institute scientific Zahra Alizadeh
Dr. Gharib st.
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6693 5855 zalizade@yahoo.com Immunology, Asthma & Allergy Research Institute Iran (Islamic Republic of) mild to moderate patients with COVID-19 who receive Hydroxy chloroquine Confirmation of the disease is based on CT scan and clinical symptoms and physician diagnosis Patients 25-65 years 25 years 65 years Both Patient with depression, COPD, sleep apnea and seizure Patients with severe kidney problem (eGFR<30 ml/min) Patients with severe liver problem Patients who receive fluvoxamine, benzodiazepine or zolpidem patients who receive drugs that extends QT Pregnant and breastfeeding mothers Patients who have allergy to melatonin U07.2 Clinically-epidemiologically diagnosed COVID-19 N/A N/A Intervention group: Prescribing 6 mg of melatonin capsules made by Elite factory for 2 weeks, which should be consumed half an hour before bedtime every night in low light conditions and even sleep in light conditions. These explanations were described to each patient. Melatonin is a hormonal supplement used to regulate sleep. Patients (if needed) receive medication prescribed by the doctor (hydroxychloroquine, acetaminophen, naproxen). Control group: Patients (if needed) receive medication prescribed by the doctor (hydroxychloroquine, acetaminophen, naproxen). Headache. Timepoint: 10-14 days. Method of measurement: COVID-19 questionnaire. Lung infection. Timepoint: 10-14 days. Method of measurement: CTscan and physician diagnosis. CRP ( C reactive protein). Timepoint: 10-14 days. Method of measurement: Lab test. Fever. Timepoint: 10-14days. Method of measurement: questionnaire. Vomiting. Timepoint: 10-14 days. Method of measurement: Questionnaire. No smelling. Timepoint: 10-14 days. Method of measurement: questionnaire. No taste. Timepoint: 10-14 days. Method of measurement: questionnaire. Cough. Timepoint: 10-14 days. Method of measurement: Questionnaire. Respiratory distress. Timepoint: 10-14days. Method of measurement: questionnaire. Tehran University of Medical Sciences Approved 2020-03-29 Ethics committee of Tehran University of Medical Sciences Enghelab st. Tehran Tehran Iran (Islamic Republic of)