]>
IRCT20190620043953N2 IRCT 2020-04-02 Yazd University of Medical Sciences Study of the effect of statins on migraine Evaluation of the effectiveness of Atorvastatin and Nortriptyline in prophylaxis of migraine attacks in patients whit classic migraine compared to standard treatment Nortriptyline: a randomized triple blind controlled clinical trial 2019-07-06 anticipated 60 Complete https://irct.ir/trial/40517 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: All patients referred to Khatamolanbia neurology clinic who fulfilled criteria for study at first are marked by a number an then assigned in two intervention and control groups alternatively by chart of random numbers. Selection of patient for first group is by lottery, Blinding description: Participants in the researchers plan and researcher committee are kept blind to the study groups. 3 migraine headaches. Intervention 1: Management group: In this group Atorvastatin 40mg tablets from Abidi company, once a day and Nortriptyline 25mg tablets from Abidi company, once a day for 24 days will be used and after 4, 14 and 24 week use a visit. Intervention 2: Control group: Atorvastatin placebo tablets; from Yazd University of Medical Sciences laboratory, once daily and Nortriptyline 25mg tablets from Abidi company once a day, for 24 days will be used your and after 4, 14 and 24 week use a visit and no extra work. Yes - There is a plan to make this available What will be shared: All collected deidentified of IPD When: Starting 6 month after publication To whom: Only available for people working in academic institutions Conditions: Only for scentific research Where to obtain: email address of roya rahmany(student of pharmacy in shahid sadoughi univercity of yazd): royarahmany9@gmail.com How to obtain: Documents will be send 2weeks after direct request by email to the corresponding author Comments:
public Roya Rahmany
Adab Ave
Yazd Iran (Islamic Republic of) 8915811113 +98 35 3830 0940 royarahmany9@gmail.com Yazd University of Medical Sciences scientific Amir Sharafat
Adab Ave
Yazd Iran (Islamic Republic of) 8915811113 +98 35 3830 0940 sherafat.a@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Age 18 to 65 years old Having at least 3 migraine attacks per month Patients who have fewer than three attacks per month Provided that the severity of the attacks is high and affects the person's life. Having a normal serum level of vitamin D3 Sufficient literacy to understand the study, use of medication and possible side effects 18 years 65 years Both Patients who do not sign a moral consent form. Patients with chronic headaches (more than 15 attacks per month). Patients receiving statin due to other diseases, such as diabetes, dyslipidemia, coronary artery disease, peripheral vascular disease, etc. Patients with severe renal insufficiency (GFR <30 ml / min) Failure to co-operate to continue treatment G43 Migraine Prevention Prevention Management group: In this group Atorvastatin 40mg tablets from Abidi company, once a day and Nortriptyline 25mg tablets from Abidi company, once a day for 24 days will be used and after 4, 14 and 24 week use a visit. Control group: Atorvastatin placebo tablets; from Yazd University of Medical Sciences laboratory, once daily and Nortriptyline 25mg tablets from Abidi company once a day, for 24 days will be used your and after 4, 14 and 24 week use a visit and no extra work Frequency of migraine headache attacks. Timepoint: 24 weeks after the start of the study. Method of measurement: Number of attacks in a month based on patient statements. Yazd University of Medical Sciences Approved 2019-11-03 Ethics committee of yazd University of Medical Sciences Alam Square, Shahid Sadoughi Pharmaceutical Faculty, Yazd yazd Yazd Iran (Islamic Republic of)