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IRCT201701089157N5 IRCT 2017-06-14 Iranian Center of Neurological Research, Tehran University of Medical Sciences, Investigation of the prophylactic effects of lisinopril on chronic migraine Prophylactic effects of lisinopril on chronic migraine Investigation of the prophylactic effects of lisinopril in comparison to placebo on chronic migraine 2017-06-20 anticipated 112 Complete https://irct.ir/trial/9762 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 3 migraine. Intervention 1: After the eligibility criteria will be applied, 112 chronic migraineurs will be selected and randomly allocated to placebo or intervention groups. Upon admission, a headache questionnaire will be given to all patients to fill out the characteristics of headaches experienced in the past month (including severity and duration of each attack). Also they will be asked not to take any medication for migraine prophylaxis and or analgesic drugs. Patients in the intervention group (n=56) will be instructed to take a tablet of Lisinopril 5 mg per day at the first week and to use 1 tablet each 12-hour thereafter (2 tablets per day from the second week to the end of the 12th week). At the same time from the beginning of the study, 4 capsules of Celebrex 100-milligram per day, thereafter the dosage will be reduced by 100-mg (1 capsule) each 5-day to zero over the first 20 days of the study. In the second week of the study the patients will be physically examined. Duration of the study will be 12 weeks and headache characteristics as well as drug response and quality of life will be assessed at the end of each month during the study. Intervention 2: After the eligibility criteria will be applied, 112 chronic migraineurs will be selected and randomly allocated to placebo or intervention groups. Upon admission, a headache questionnaire will be given to all patients to fill out the characteristics of headaches experienced in the past month (including severity and duration of each attack). Also they will be asked not to take any medication for migraine prophylaxis and or analgesic drugs. Patients in the placebo group (n=56) will be instructed to take a tablet of placebo per day at the first week and to use 1 tablet each 12-hour thereafter (2 tablets per day from the second week to the end of the 12th week). At the same time from the beginning of the study, 4 capsules of Celebrex 100-milligram per day, thereafter the dosage will be reduced by 100-mg (1 capsule) each 5-day to zero over the first 20 days of the study. In the second week of the study the patients will be physically examined. Duration of the study will be 12 weeks and headache characteristics as well as drug response and quality of life will be assessed at the end of each month during the study.
public Prof. Mansoureh Togha
Sina Hospital, Hasan Abad Sq., Imam Khomeini Ave.
tehran Iran (Islamic Republic of) 1136746911 +98 21 6670 2052 toghae@sina.tums.ac.ir Sina Hospital, Tehran University of Medical Sciences scientific Prof. Mansoureh Togha
Sina Hospital, Hasan Abad Sq., Imam Khomeini Ave.
tehran Iran (Islamic Republic of) 1136746911 +98 21 6670 2052 toghae@sina.tums.ac.ir Sina Hospital, Iranian Center of Neurological Research,Tehran University of Medical Sciences Iran (Islamic Republic of) Patients will be included in the study due to the following inclusion Criteria: having ≥ 15 headache days per month for at least 3 months, history of migraine for at least 1 year, age 18-45 years, systolic blood pressure between 110-140 mmHg Taking a large amount of abortive drugs. The exclusion criteria were as follows: having psychiatric illness, having major neurological disorders and / or other chronic or systemic diseases, being pregnant or have a planned pregnancy, breastfeeding, taking prophylactic medications in the last 4 weeks, suffering from impaired liver function or kidney disorders, allergies to ACE inhibitors, history of angionearotic edema suffering from secondary headaches. 18 years 45 years Both Treatment - Drugs Placebo After the eligibility criteria will be applied, 112 chronic migraineurs will be selected and randomly allocated to placebo or intervention groups. Upon admission, a headache questionnaire will be given to all patients to fill out the characteristics of headaches experienced in the past month (including severity and duration of each attack). Also they will be asked not to take any medication for migraine prophylaxis and or analgesic drugs. Patients in the intervention group (n=56) will be instructed to take a tablet of Lisinopril 5 mg per day at the first week and to use 1 tablet each 12-hour thereafter (2 tablets per day from the second week to the end of the 12th week). At the same time from the beginning of the study, 4 capsules of Celebrex 100-milligram per day, thereafter the dosage will be reduced by 100-mg (1 capsule) each 5-day to zero over the first 20 days of the study. In the second week of the study the patients will be physically examined. Duration of the study will be 12 weeks and headache characteristics as well as drug response and quality of life will be assessed at the end of each month during the study. After the eligibility criteria will be applied, 112 chronic migraineurs will be selected and randomly allocated to placebo or intervention groups. Upon admission, a headache questionnaire will be given to all patients to fill out the characteristics of headaches experienced in the past month (including severity and duration of each attack). Also they will be asked not to take any medication for migraine prophylaxis and or analgesic drugs. Patients in the placebo group (n=56) will be instructed to take a tablet of placebo per day at the first week and to use 1 tablet each 12-hour thereafter (2 tablets per day from the second week to the end of the 12th week). At the same time from the beginning of the study, 4 capsules of Celebrex 100-milligram per day, thereafter the dosage will be reduced by 100-mg (1 capsule) each 5-day to zero over the first 20 days of the study. In the second week of the study the patients will be physically examined. Duration of the study will be 12 weeks and headache characteristics as well as drug response and quality of life will be assessed at the end of each month during the study. Migraine headache severity. Timepoint: first month, second month, third month. Method of measurement: Visual Analog Scale (VAS). Migraine headache duration. Timepoint: first month, second month, third month. Method of measurement: Migraine headache diary. Migraine headache frequency. Timepoint: first month, second month, third month. Method of measurement: Migraine headache diary. Remission from Chronic Migraine to Episodic Migraine. Timepoint: first week, second month. Method of measurement: physical examination, headache diary. Iranian Center of Neurological Research, Tehran University of Medical Sciences, Approved 2017-01-07 Tehran University of Medical Sciences Qhods St., Keshavarz Boulevard tehran Iran (Islamic Republic of)