This study is clinical trial, double blind and cross over. Patients divided to two groups randomly. Participants were randomized in a 1:1 ratio to receive either valproate Na 400 Mg or magnesium oxide 500 mg twice a day for two months. After 4 weeks of washout, participants crossed over to receive the alternative intervention for 2 months. The intensity of migraine headache is evaluated with IV grading and VAS 1-10 and we used questionnaire Migraine Disability Assessment Test that is a test used by doctors to determine how severely migraines affect a patient's life. Inclusion criteria: migraine headache on based criteria HIS; age between 15-65 years old; migraine headache from 6 month ago, headache frequency: more than twice a month with moderate or severe intensity; not used valproate Na and MG within the past 30 days. Exclusion criteria: pregnancy, breastfeeding, renal and hepatic failure, non migraine headache, abused smoke and opium.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015011716666N2
Registration date:2015-03-05, 1393/12/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-05, 1393/12/14
Registrant information
Name
Narges Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3311 6275
Email address
n.karimi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2015-03-01, 1393/12/10
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of magnesium oxide and sodium valproate in migraine prophilaxis: A prospective double blind randomized clinical trial
Public title
The comparison of the effect of magnesium oxide and sodium valproate in migraine prophilaxis:
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: migraine headache on based criteria IHS; age between 15-65 years old; migraine headache from 6 month ago; headache frequency: more than twice a month with moderate or sever intensity; not used valproate Na and MG within the past 30 days.
Exclusion criteria: pregnancy; breastfeeding; renal and hepatic failure; non migraine headache; smoking and opium and substance abuse.
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sceinces
Street address
Mazandaran University of Medical Sceinces, Joibar three way
City
Sari
Postal code
Approval date
2014-11-19, 1393/08/28
Ethics committee reference number
791
Health conditions studied
1
Description of health condition studied
Migrain headache
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Headache intensity
Timepoint
2 months after used drug
Method of measurement
Questionnaire MIDAS and VAS 1-10
2
Description
Headache frequency
Timepoint
2 months after used drug
Method of measurement
Questionnaire MIDAS
3
Description
Headache duration
Timepoint
2 months after used drug
Method of measurement
Questionnaire MIDAS
Secondary outcomes
1
Description
Headache symptom
Timepoint
2 month after use drug
Method of measurement
Questionnair
Intervention groups
1
Description
Control group: Tab. Valproat Na 200mg BD for 2 month
Category
Treatment - Drugs
2
Description
intervention: tab magnesium oxide 250 mg BD for 2 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tooba clinic
Full name of responsible person
Narges Karimi
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sceinces
Full name of responsible person
Ahmad Ali Enayati
Street address
Moalem square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sceinces
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sceinces
Full name of responsible person
Narges karimi
Position
Neurologist
Other areas of specialty/work
Street address
Bou Ali Sina hospital
City
Sari
Postal code
Phone
+98 11 3334 3018
Fax
Email
drkarimi_236@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sceinces
Full name of responsible person
Narges karimi
Position
Neurologist
Other areas of specialty/work
Street address
Bou Ali Sina hospital
City
Sari
Postal code
Phone
+98 11 3334 3018
Fax
Email
drkarimi_236@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Narges Karimi
Position
Neurologist
Other areas of specialty/work
Street address
City
Sari
Postal code
Phone
+98 33343018
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)