Objective: Comparison of the effectiveness of two types of drugs in migraine prophylaxis.
Study design: Sampling, random, non-blind
Study population: Patients that refer to neurology clinics of hospitals of the Islamic Azad University in Tehran in 2012-2014 years that suffer from migraine base on the diagnosis of the treating physician.
Inclusion criteria: Patients with migrain that they did not receive eny other medicine in the past two months.
Exclusion criteria: The incidence of major complications (side effects that need to cut the treatment, if they occuered)
A sample of 120 patients with migraine that were referred to one of two study groups were formed two groups of sixty people.
Interventions: drug venlafaxine 37.5 mg dose twice a day for the first group and drug nortriptyline dose of 25 mg once a day for the second group.
Time of Intervention: prophylactic treatment with drugs listed in a period of one month.
The outcomes: It is expected after a period of study in duration, intensity and frequency of migraine attacks will occur changes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015091524041N1
Registration date:2016-03-20, 1395/01/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-20, 1395/01/01
Registrant information
Name
Nima Mohsenzadeh Kermani
Name of organization / entity
Islamic Azad University Tehran Medical Branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2258 5621
Email address
nmohsenzadeh@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Islamic Azad University of Medical Scienses
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of venlafaxine with nortriptyline in migraine prophylaxis
Public title
The effects of drugs on migraine
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with migraine that they did not receive other drugs in the past two months.
Exclusion criteria: The incidence of major complications (side effects that need to cut the treatment, if they happened)
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization:alternatly in order of presentation of paitients
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University Tehran Medical Branch
Street address
Islamic Azad University Tehran Medical Branch,Khaghani Avenue,Shariati Street,Tehran,IRAN
City
Tehran
Postal code
193951495
Approval date
2016-02-24, 1394/12/05
Ethics committee reference number
IR.IAU.TMU.REC.1394.30
Health conditions studied
1
Description of health condition studied
migrain
ICD-10 code
G43.0
ICD-10 code description
common migrain
Primary outcomes
1
Description
frequency of Migraine headache
Timepoint
Before the intervention,one month after intervention
Method of measurement
Questionnaire
2
Description
intensity of Migraine headache
Timepoint
Before the intervention,one month after intervention
Method of measurement
Questionnaire
3
Description
duration of Migraine headache
Timepoint
Before the intervention,one month after intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the control group: oral medication nortriptyline(tablet) 25 mg once a day for a month(Made in Abidi Company)
Category
Treatment - Drugs
2
Description
In the intervention group: oral medication venlafaxine(Tablet) 37.5 mg dose twice a day for one month.(made in Abidi Company)