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IRCT20220331054378N1 IRCT 2022-04-23 Alborz University of Medical Sciences The investigation of the Effect of Melatonin Supplement on Dermatitis The investigation of the effect of Melatonin Supplement on Dermatitis Severity in Patients: a randomized, double-blinded, placebo-controlled clinical trial 2022-07-07 anticipated 80 Complete https://irct.ir/trial/62690 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Being in melatonin tablet or placebo group is based on Permuted Block Randomization. Individual stratified randomization is performed. Random blocks are generated by computer statistical software. Patients enter blocks including four and receive melatonin tablet or placebo in a randomized manner. Allocation concealment is carried out. Physician, patient and first researcher are not aware of patients' group, Blinding description: The physician, the first researcher and patient are unaware of the melatonin or placebo allocation. The second researcher is not blinded. The second researcher repackages tablets of melatonin and placebo without name but with codes and gives them to the first researcher. The second researcher has no intervention in allocation of patients and outcome assessment. The first researcher receives packages containing melatonin or placebo and delivers them to patients. The first researcher is involved in outcome assessment and is unaware that patients receive melatonin or placebo. 3 Dermatitis. Intervention 1: Intervention group: Patients in drug group receive a tablet containing 10 mg of melatonin from Jalinous pharmaceutical company, every night 1 hour before bed for 4 weeks. Patients also receive routine and main dermatitis treatment regimen. Intervention 2: Control group: The placebo group receives an ineffective pill for 4 weeks every night 1 hour before bedtime. Patients also receive routine and main dermatitis treatment regimen. 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 It is not yet known if there will be a plan to make this available
public Maryam Daei
Next to the Imam Ali hospital, Valia'sr Ave, Shora Blvd, Azimieh, Karaj
Karaj Iran (Islamic Republic of) 3154686689 +98 26 3256 7175 maryamdaei@yahoo.com Alborz University of Medical Sciences scientific Maryam Daei
Next to the Imam Ali hospital, Valia'sr Ave, Shora Blvd, Azimieh, Karaj
Karaj Iran (Islamic Republic of) 3154686689 +98 26 3256 7175 maryamdaei@yahoo.com Alborz University of Medical Sciences Iran (Islamic Republic of) 12 year-old or older patients with dermatitis which has affected at least 5% of whole body Signing the consent form by the patient. 12 years no limit Both Patients receiving systemic treatment for their dermatitis (exception: antihistamines). Patients receiving sedatives. Patients with history of allergic reactions to Melatonin or other ingredients in tablets. If a patient refuses to continue the study at any time after the study started. Treatment - Drugs Placebo Intervention group: Patients in drug group receive a tablet containing 10 mg of melatonin from Jalinous pharmaceutical company, every night 1 hour before bed for 4 weeks. Patients also receive routine and main dermatitis treatment regimen. Control group: The placebo group receives an ineffective pill for 4 weeks every night 1 hour before bedtime. Patients also receive routine and main dermatitis treatment regimen. Severity of dermatitis. Timepoint: Beginning and the end of the study. Method of measurement: SCORAD index. Quality of Sleep. Timepoint: Beginning and the end of the study. Method of measurement: ISI and ADSS index. Quality of Life. Timepoint: Beginning and the end of the study. Method of measurement: DLQI index. Severity of pain. Timepoint: Beginning and the end of the study. Method of measurement: NRS index. Severity of itching. Timepoint: Beginning and the end of the study. Method of measurement: 12-PSS index. Alborz University of Medical Sciences Approved 2022-03-16 Ethics committee of Alborz University of Medical Sciences Office of the Ethics Committee, Second floor, Deputy of Research and Technology, Saffarian Alley, 45 meter Golshahr, Karaj Karaj Alborz Iran (Islamic Republic of)