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IRCT20190107042264N5 IRCT 2022-11-02 Ahvaz University of Medical Sciences Studying the effect of melatonin on migraine The effect of melatonin on reducing the frequency and intensity of migraine attacks 2022-11-06 anticipated 60 Complete https://irct.ir/trial/65479 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block randomization method was used in 3 blocks of 20 people, using the free statistical software available on the Randomization.org website without using stratified randomization to create a random sequence. Then, each obtained number was assigned a unique arbitrary code, including capital letters and numbers, using the Random.org website for concealment. The statistician delivers these codes to the pharmacist to prepare medicine packages, and the coding of identical packages is done with them, Blinding description: All participants use the same medicine packages, the contents of which are the same in terms of color, size, smell, and shape. Principal investigators are unaware of the coding performed by the statistician. Doctors, interviewers, and data collection officials are only aware of the code assigned to the patients and do not know to which study group the patient belongs. The study codes will remain with the project statistician until the end of the study. The statistician will decode them during the statistical analysis at the end of the study. 3 Migraine Headaches. Intervention 1: Intervention group: In both groups of patients, propranolol 20 mg twice a day is used as a standard anti-migraine treatment. In the Intervention group, 3 mg melatonin tablets (Razak company) are given. The prescription is to take medicine one hour before going to bed. The intervention will continue for two months, and the study data will be collected before the intervention, in the first month, the second month, the third month, and the fourth month after the intervention. Intervention 2: Control group: In both groups of patients, propranolol 20 mg twice a day is used as a standard anti-migraine treatment. In the control group, the same placebo in terms of shape, color, smell, size and taste prepared at the Faculty of Pharmacy of Jundishapur University of Ahvaz is given. The prescription is to take the medicine one hour before going to bed. The intervention will continue for 2 months and the study data will be collected before the intervention, the first month, the second month, the third month and the fourth month after the intervention. 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 Asieh Mehramiri
Golestan Teaching Hospital - Farvardin St - Golestan
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3374 3001 mehramiri.ac@gmail.com Ahvaz University of Medical Sciences scientific Asieh Mehramiri
Golestan Teaching Hospital - Farvardin St - Golestan
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3374 3001 mehramiri.ac@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Confirmation of migraine according to the criteria of the International Headache Society Chronic migraine patients who are able to distinguish migraine from non-migraine headaches Patients who do not have primary internal and neurologic complaints, there is no other reason for headache in them Filling the written consent form to participate in the study at least 1 year of migraine history 18 years no limit Both Severe and debilitating migraine (to eliminate the therapeutic effects of excessive use of painkillers) Chronic daily headache Taking drugs other than propranolol to prevent attacks or taking sleeping pills Migraine Disability Assessment (MIDAS) Grade 4 Treatment-resistant migraine (history of unsuccessful treatment with two or more migraine drug classes) History of abnormal use of painkillers and Medication Overuse Headache Significant psychological disorders (psychological illnesses leading to chronic drug use for at least six months) Pregnancy and breastfeeding Primary medical conditions and surgeries that require medical interventions (including contraindications to beta-blockers) Presence of multiple chronic headaches other than migraine with or without medical treatment, such as tension headache History of melatonin allergy or adverse events Patient's request to withdraw from the study due to drug side effects or other reasons G43 Migraine Treatment - Drugs Placebo Intervention group: In both groups of patients, propranolol 20 mg twice a day is used as a standard anti-migraine treatment. In the Intervention group, 3 mg melatonin tablets (Razak company) are given. The prescription is to take medicine one hour before going to bed. The intervention will continue for two months, and the study data will be collected before the intervention, in the first month, the second month, the third month, and the fourth month after the intervention. Control group: In both groups of patients, propranolol 20 mg twice a day is used as a standard anti-migraine treatment. In the control group, the same placebo in terms of shape, color, smell, size and taste prepared at the Faculty of Pharmacy of Jundishapur University of Ahvaz is given. The prescription is to take the medicine one hour before going to bed. The intervention will continue for 2 months and the study data will be collected before the intervention, the first month, the second month, the third month and the fourth month after the intervention. Severity. Timepoint: 1, 2, 3 and 4 months after start of treatment. Method of measurement: Visual Analog Scale. Frequency. Timepoint: 1, 2, 3 and 4 months after start of treatment. Method of measurement: Headache Diary. Ahvaz University of Medical Sciences Approved 2022-04-19 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Esfand Street, Golestan, Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)