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IRCT20170316033099N12 IRCT 2021-01-02 Birjand University of Medical Sciences The effectiveness of melatonin on migraine headaches Comparison of the efficacy of propranolol alone and propranolol plus melatonin on the severity, duration, and number of migraine attacks in patients with migraine headaches 2020-03-03 anticipated 40 Complete https://irct.ir/trial/53210 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each patient was assigned to either the intervention group (A) or group (B) by removing one card from a box containing 20 A and 20 B cards. 3 migraine. Intervention 1: Intervention group 1 (propranolol): propranolol, 20 mg oral tablets, once daily for three months. Intervention 2: Intervention group 2 (propranolol plus melatonin): 20 mg propranolol tablets plus 3 mg melatonin capsules, each once daily for three months. Yes - There is a plan to make this available What will be shared: IPD When: Up to six months from the publication of the article extracted from the study project To whom: researchers Conditions: for research purposes Where to obtain: personal correspondence with the corresponding author via email How to obtain: email to the corresponding author Comments:
public Sajjad Rafiei
Ghaffari Ave.
Birjand Iran (Islamic Republic of) 9717853577 +98 56 3239 5641 q.armageddon@gmail.com Birjand University of Medical Sciences scientific Dr. Zahra Ahmadi
Ghaffari Ave.
Birjand Iran (Islamic Republic of) 9717853577 +98 56 3162 6000 zahra.ahmadi83@yahoo.com Birjand University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Confirmed migraine as per the indices of the International Headache Society Age between 18 and 65 years Residence in South Khorasan Province An average of two migraine attacks per month A minimum of one-year history of migraine The first migraine attack occurring before age 50 Informed consent for participation 18 years 65 years Both History of headaches lasting longer than 15 days a month History of any neurological disorder other than migraine Allergy to the study medications Presence of debilitating diseases such as cancer and autoimmune diseases, advanced diabetes, etc. Pregnancy and lactation Persistent headache History of seizures and epilepsy History of neurological and mental illnesses G43 Migraine Treatment - Drugs Treatment - Drugs Intervention group 1 (propranolol): propranolol, 20 mg oral tablets, once daily for three months Intervention group 2 (propranolol plus melatonin): 20 mg propranolol tablets plus 3 mg melatonin capsules, each once daily for three months Pain severity. Timepoint: study onset, fourth week, eighth week, and twelfth week. Method of measurement: visual analog scale. Pain duration. Timepoint: fourth week, eighth week, and twelfth week. Method of measurement: patient's report. Number of migraine attacks. Timepoint: fourth week, eighth week, and twelfth week. Method of measurement: patient's report. Birjand University of Medical Sciences Approved 2020-03-02 Ethics Committee of Birjand University of Medical Sciences Ghaffari Ave. Birjand South Khorasan Iran (Islamic Republic of)