The Aim of this trial is to study the effect of folic acid on migraine headache. This study is a double-blinded clinical trial. Ninety patients with confirmed migraine headache will randomly allocated into three groups. Migraine headache will be confirmed by the International Headache Society scale (IHS).
Intervention 1: conventional therapy (i.e. 10 milligrams Nortriptyline nightly plus 200 milligrams Depakin daily) plus folic acid 1 milligram daily.
Intervention 2: conventional therapy (i.e. 10 milligrams Nortriptyline nightly plus 200 milligrams Depakin daily) plus folic acid 5 milligrams daily.
control: conventional therapy without folic acid (i.e. 10 milligrams Nortriptyline nightly plus 200 milligrams Depakin daily).
We will follow patients monthly after start of treatment to 3 months they will be visited in the neurology clinic again and the intensity and frequency of headache during three months in all groups will be measured by MIDAS scale.
Inclusion criteria: 20-50 years; getting no treatment for Migraine in the previous 3 months; not being pregnant or lactating; having no systemic disease or intracranial lesion.
Exclusion criteria: any drug side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041920258N39
Registration date:2017-06-03, 1396/03/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-03, 1396/03/13
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Arak University of Medical Sciences
Expected recruitment start date
2015-08-25, 1394/06/03
Expected recruitment end date
2016-08-24, 1395/06/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of folic acid on migraine headache
Public title
The effect of folic acid on migraine headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 20-50 years; getting no treatment for Migraine in the previous 3 months; not being pregnant or lactating; having no systemic disease or intracranial lesion.
Exclusion criteria: any drug side effects
Age
From 20 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Dr Mohammad Rafie, Vice Chancellor Research, Payambar Azam complex, Basij square, Sardasht, Arak
City
Arak
Postal code
38149578558
Approval date
2015-08-24, 1394/06/02
Ethics committee reference number
IR.ARAKMU.REC.1394.155
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
headache
Timepoint
monthly after start of treatment to 3 months
Method of measurement
MIDAS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:10 milligram nortriptyline nightly with 200 milligram Depakin daily and folic acid 1 milligram daily.
Category
Treatment - Drugs
2
Description
Intervention group 2: 10 milligram nortriptyline nightly with 200 milligram Depakin daily and folic acid 5 milligram daily
Category
Treatment - Drugs
3
Description
Control group: 10 milligram nortriptyline nightly with 200 milligram Depakin daily.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Fardin Faraji
Street address
Valiasr hospital, Valiasr squre, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For Research, Arak University of Medical Sciences