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IRCT20200408046990N12 IRCT 2022-11-15 Mashhad University of Medical Sciences Evaluation of the melatonin tablet efficacy as an adjuvant therapy for patients with mild to moderate COVID-19 Evaluation of melatonin tablet efficacy as an adjuvant treatment for patients with mild to moderate COVID-19 in Qaem and Imam Reza Hospital, Mashhad: A triple-blind randomized placebo controlled clinical trial 2022-10-25 anticipated 40 Complete https://irct.ir/trial/66470 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocked randomization using website https://www.sealedenvelope.com With the explanation that each block has 4 members and the shape of the blocks can be as follows: [ABAB], [ABBA, [AABB],[BBAA],[BABA][BAAB] Code A belongs to the intervention group and code B belongs to the control group. the mentioned website selects 10 blocks from Quadruple blocks and patients will be assigned to blocks in the order of entry into the study and finally 40 patients will enter the study, Blinding description: The melatonin and the placebo tablets will be packaged in identical-looking bottle and delivered to the clinician. Patients who meet the inclusion criteria will be selected by clinician to be included in the study, randomly assigned to a drug or placebo group and given a bottle with A or B mark. Patients will be evaluated in the course of treatment by the physician and the pharmacy student. Data collection and analysis will be performed by the pharmacy student and the clinical pharmacist. All of them will be unaware that A or B is on medication or placebo until the end of the study and data analysis. 3 COVID-19 pneumonia. Intervention 1: Intervention group: three melatonin 3mg tablet daily for two weeks. Intervention 2: Control group: placebo with same appearance of melatonin tablet three daily for 2 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information is available
public Sepideh Elyasi
Faculty of Pharmacy; Ferdowsi University; Vakilabad Boulevard
Mashhad Iran (Islamic Republic of) 17871 91886 +98 51 3180 1588 elyasis@mums.ac.ir Mashhad University of Medical Sciences scientific Sepideh Elyasi
Faculty of Pharmacy, Ferdosi University, Vakilabad Aven.
Mashhad Iran (Islamic Republic of) 17871 91886 +98 51 3180 1588 elyasis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Clinical or laboratory diagnosis of mild to moderate COVID-19 Age between 18-85 y Sign of written consent 18 years 85 years Both Pregnancy and lactation History of allergy to melatonin Immunosuppression history Lactase deficiency Concomitant use of alcohol and 1A2 inhibitors U07.1 COVID-19, virus identified Treatment - Drugs Placebo Intervention group: three melatonin 3mg tablet daily for two weeks Control group: placebo with same appearance of melatonin tablet three daily for 2 weeks Fever. Timepoint: Daily. Method of measurement: Thermometer. Clinical response to the treatment (including improvement of cough, myalgia, headache, olfactory and taste disorders). Timepoint: Daily. Method of measurement: Based on patients examination and interview. Radiologic improvement. Timepoint: Two weeks after treatment. Method of measurement: Lung CT scan. Laboratory response. Timepoint: Weekly. Method of measurement: Assessment of lymphocyte count. Drug adverse reaction. Timepoint: Daily. Method of measurement: Patient file and interview. Duration of the hospitalization. Timepoint: End of the treatment. Method of measurement: Patient's file. Patient's final outcome. Timepoint: End of the treatment. Method of measurement: Patient's file. Mashhad University of Medical Sciences Approved 2020-05-16 Ethics committee of Mashhad University of Medical Sciences Qureshi Building, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)