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IRCT20121216011763N40 IRCT 2019-12-15 Esfahan University of Medical Sciences The effect of melatonin supplementation on migraine The effect of melatonin supplementation on symptoms of headache and CGRP in women with migraine 2020-02-20 anticipated 88 Complete https://irct.ir/trial/44008 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The total number of specimens randomly assigned by the process will be divided into two groups by random blocks and each group will consist of 44 persons. The blocking method will be used for randomization. To do this, a random allocation sequence will be created through the reputable website https://www.sealedenvelope.com/simple-randomiser/v1/lists, Blinding description: This study is a double blind clinical trial (participant, researcher). Melatonin supplement and placebo will be packaged in similar boxes and the researcher and patients will not be informed of the contents of the packs until the end of the study. N/A Condition 1: Migraine. Condition 2: Migraine. Intervention 1: Intervention group: Daily melatonin 3 mg half an hour before bedtime for 8 weeks. Intervention 2: Control group: One placebo daily (50 mg starch) half an hour before bedtime for 8 weeks. Yes - There is a plan to make this available What will be shared: An identifiable data file related to the main outcome will be shared. When: 12 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: To do similar designs Where to obtain: Dr. Gholamreza Askari askari@mui.ac.ir How to obtain: Information will be sent after receiving the request Comments:
public Fatemeh Moradi
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 1792 2110 f.moradi224@gmail.com Esfahan University of Medical Sciences scientific Gholamreza Askari
Hezar Jajrib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 1792 2110 askari@mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Women from the age of 18 to menopause Diagnosis of migraine by a neurologist Willing to work with the project 18 years 55 years Female People with a history of overdose of analgesics according to IHS criteria for antidepressant abuse Pregnancy or breast-feeding History of significant complications or recent use of melatonin supplements Severe depression in the past year G43.0 G43.1 Migraine Migraine Treatment - Drugs Placebo Intervention group: Daily melatonin 3 mg half an hour before bedtime for 8 weeks Control group: One placebo daily (50 mg starch) half an hour before bedtime for 8 weeks Migraine symptoms (severity, frequency, duration of migraine). Timepoint: Week 0 and Week 8. Method of measurement: Questionnaire. Serum levels of calcitonin-associated peptide (CGRP). Timepoint: Week 0 and Week 8. Method of measurement: Laboratory analysis (blood test). Depression, stress, anxiety. Timepoint: week 0 and week 8. Method of measurement: DASS-21questionnaire. Quality of Life in Migraine Patients. Timepoint: week 0 and week 8. Method of measurement: Migraine –Specific Quality of Life(MSQ)questionnaire. Esfahan University of Medical Sciences Approved 2019-11-05 Ethics committee of Isfahan University of Medical Sciences Hezar Jarib Isfahan Isfehan Iran (Islamic Republic of)