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
Evaluation of the efficacy of atorvastatin and nortriptyline compared with placebo and nortriptyline in controlling migraine attacks
Design
Clinical trial with control group, with parallel groups, blind and randomized trials
Settings and conduct
Sample selection at Imam Mohammad Bagher Clinic of Bam and Clinic of Afshar Hospital in Yazd city with satisfaction and knowledge of patients and considering the conditions for entering the study is done.
Participants/Inclusion and exclusion criteria
Only patients aged 18 to 65 years with a migraine diagnosis based on the IHS criteria of at least six months before the start of the study, and normal levels of vitamin D3 (greater than 30ng / mL) will be included. New patient cases that are scheduled to be studied should have at least 3 migraine attacks per month. Patients with fewer than three attacks per month will be included in the study, provided that the attacks are highly intense and affect the patient's life.
Intervention groups
The efficacy of atorvastatin in combination with nortriptyline in decreasing the severity and severity of migraine attacks and improving the quality of life of patients and not taking atorvastatin and prescribing nortriptyline alone in the control group
Main outcome variables
the severity of migraine attacks; the frequency of migraine attacks; quality of life; side effects of treatment.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190620043953N2
Registration date:2020-04-02, 1399/01/14
Registration timing:retrospective
Last update:2020-04-02, 1399/01/14
Update count:0
Registration date
2020-04-02, 1399/01/14
Registrant information
Name
Amir Sharafat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3828 6667
Email address
dr.sharafat.amir@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-06, 1398/04/15
Expected recruitment end date
2019-09-06, 1398/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Study of the effect of statins on migraine
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
Blinding description
Participants in the researchers plan and researcher committee are kept blind to the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of yazd University of Medical Sciences
Street address
Alam Square, Shahid Sadoughi Pharmaceutical Faculty, Yazd
City
yazd
Province
Yazd
Postal code
1111111111
Approval date
2019-11-03, 1398/08/12
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.197
Health conditions studied
1
Description of health condition studied
migraine headaches
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Prevention
2
Description
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