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IRCT20210410050915N1 IRCT 2021-05-12 Esfahan University of Medical Sciences Therapeutic effect of mirtazapine with venlafaxine in the treatment of tension headaches Comparative study of the therapeutic effect of mirtazapine with venlafaxine in the treatment of tension headaches 2021-05-22 anticipated 130 Complete https://irct.ir/trial/55879 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization and allocation of each eligible patient in both intervention and control groups will be done by random block method. The intervention is in the form of three blinds so that the patient and the researcher and analyzer will not know the type of drug to treat patients.The file numbers are entered in Excel, then the random number is selected from the data analysis command. This study has 2 groups that can be numbered from 1 to 2, respectively. We also want to have 65 people in each group. As a result, sequences 1 to 2 should be repeated 65 times each time. It is clear that the repetition of each number occurs once in each group, so select 1 for repeating each number and 65 for repeating the sequence. In this way, 130 units will be produced. Which patient is included in which group, Blinding description: The intervention is in the form of three blinds so that the patient and the researcher and analyzer will not know the type of drug to treat patients. 3 Tension headaches. Intervention 1: Intervention group: Mirtazapine 15 mg daily. Intervention 2: Control group: Venlafaxine 37.5 g daily. 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 more information
public Ahmad Chitsaz
Isfahan University of Medical Sciences, Hezar Jarib St.,
Isfahan Iran (Islamic Republic of) 8174673461 +98 913 310 1971 ahmadchitsaz@med.mui.ac.ir Esfahan University of Medical Sciences scientific Ahmad Chitsaz
Isfahan University of Medical Sciences, Hezar Jarib St.,
Isfahan Iran (Islamic Republic of) 8174673461 +98 913 310 1971 ahmadchitsaz@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) All patients for whom the diagnosis of tension headache has been confirmed by a neurologist. The patient has the consent to participate in the study. no limit no limit Both Patients who do not have the consent to enter the study. Patients with chronic physical diseases such as kidney-liver, heart, lung, cancer, autoimmune, etc. and mental problems. A specialist doctor has diagnosed them with other headaches such as migraines. G44.0 Cluster headaches and other trigeminal autonomic cephalgias (TAC) Treatment - Drugs Treatment - Drugs Intervention group: Mirtazapine 15 mg daily Control group: Venlafaxine 37.5 g daily Reduce pain. Timepoint: Before the intervention, three months and six months later. Method of measurement: Comparison of therapeutic effect of mirtazapine with venlafaxine. Esfahan University of Medical Sciences Approved 2021-02-19 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib St., Shiraz Gate Isfahan Isfehan Iran (Islamic Republic of)