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IRCT20170814035697N6 IRCT 2020-12-25 Oroumia University of Medical Sciences Effects of venlafaxine and amitriptyline on migraines The Comparative Study of Preventive Effects of Venlafaxine with Amitriptyline in Migrainous Patients 2020-07-05 anticipated 80 Complete https://irct.ir/trial/49169 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Both drugs are in the same package. 40 packs of Venlafaxine 37.5 will be in a box called V and 40 packs of amitriptyline 25 will be in a box called A. 40 cards with the letter A and 40 cards with the letter V will be placed in a box. For each patient who is eligible to receive both drugs after the examination, one of the cards is accidentally taken out of the box and one of the two drugs venlafaxine or amitriptyline is given to the patient, Blinding description: Participants in the project, researcher, and mentor will be blind to the drug used by patients. But the doctor will be informed about the medication. The medicines will be packed in similar envelopes and placed in two boxes with the signs that only the doctor will know about. Patients are first told that they will take one of the two drugs venlafaxine 37.5 or amitriptyline 25 randomly (e.g., first patient, amitriptyline, and second patient, venlafaxine, and so on), but depending on which drug they will consume, will be unaware. 3 Migraine. Intervention 1: Intervention group: venlafaxine taking group. Intervention in this group: Patients will take one venlafaxine tablet with a dose of 37.5 per day made by Sami Saz Pharmaceutical Company for 8 weeks. Intervention 2: Control group: amitriptyline taking group. Intervention in this group: Patients will take one amitriptyline tablet with a dose of 25 per day made by Iran Daru Pharmaceutical Company for 8 weeks. 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 My decision to publish depends on the opinion of other project partners.
public Mohaddeseh Hedayat
School of Pharmacy, Nazlou Campus, Urmia University of Medical Sciences, Urmia, I.R.IRAN
Urmia Iran (Islamic Republic of) 5756115327 +98 44 3275 4993 Mohaddeseh_Hedayat@yahoo.com Oroumia University of Medical Sciences scientific Surena Nazarbaghi
Urmia University of Medical Sciences ;Resalat Ave;Jahad Blvd;Urmia;Iran
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3278 0803 nazarbaghi_s@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) People with migraine People who experience 3 or more attacks each month People who have never used amitriptyline or venlafaxine to manage their attacks 18 years 60 years Both People who are pregnant or planning to become pregnant in the next two months People with a history of specific cardiovascular or cerebral surgery People with a history of seizures People with high blood pressure people with Benign prostatic hyperplasia People with glaucoma G43 Migraine Treatment - Drugs Treatment - Drugs Intervention group: venlafaxine taking group. Intervention in this group: Patients will take one venlafaxine tablet with a dose of 37.5 per day made by Sami Saz Pharmaceutical Company for 8 weeks. Control group: amitriptyline taking group. Intervention in this group: Patients will take one amitriptyline tablet with a dose of 25 per day made by Iran Daru Pharmaceutical Company for 8 weeks. Incidence of Headache. Timepoint: At the beginning of the study and two months after the start of the study. Method of measurement: The six-item Headache Impact Test. Headache Impact Test is a tool used to measure the impact headaches have on your ability to function on the job, at school, at home and in social situations.Your score shows you the effect that headaches have on normal daily life and your ability to function. Headache Impact Test was developed by an international team of headache experts from neurology and primary care medicine in collaboration with the psycho metricians who developed the SF-36®health assessment tool. This questionnaire was designed to help you describe and communicate the way you feel and what you can not do because of headaches. Severity of attacks. Timepoint: At the beginning of the study and two months after the start of the study. Method of measurement: The six-item Headache Impact Test. Duration of attacks. Timepoint: At the beginning of the study and two months after the start of the study. Method of measurement: The six-item Headache Impact Test. Number of attacks. Timepoint: At the beginning of the study and two months after the start of the study. Method of measurement: The six-item Headache Impact Test. Oroumia University of Medical Sciences Approved 2020-06-02 ٍEthics committee of Urmia University of Medical Sciences Urmia University of Medical Sciences; Resalat Ave; Jahad Blvd; Urmia; West Azerbijan Provine; Iran Urmia West Azarbaijan Iran (Islamic Republic of)