(1) Objectives: Aim of this study is to evaluate the probable effect of Magnesium as a prophylactic agent on functional outcome of patients with Migraine headache.(2) Design: Randomized, Double-blind, Placebo-controlled, Single center, Phase 2 trial. (3) Setting and conduct: Patients with migraine headache divided in two groups (55 patients in each group). The intervention groupl received Propranolol and Magnesium oxide tablet; and the control group received Propranolol and placebo tablet. Number of migraine attacks in month (frequency), headache severity and MIDAS Scale (Migraine Disability Assessment Questionnaires) were assessed after 1 month and 3 month after initiation of drugs.
(4) Participants including major eligibility criteria: 110 patients. Major inclusion criteria: Patients with a history of moderate or severe migraine headache with or without aura. Major exclusion criteria: Patients lesser than 15 and more than 50 years old, history of active peptic ulcer; history of diabetes mellitus; asthma; severe depression; heart failure. (5) Intervention:1- Propranolol tablet 20 mg twice daily and Magnesium oxide tablet 500 mg twice daily in intervention group
2- Propranolol tablet 20 mg twice daily and placebo tablet twice daily in control group.
(6) Main outcome measures (variables): 1- Severity of headache 2- Frequency of headache 3- MIDAS score.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013010411995N1
Registration date:2013-04-15, 1392/01/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-04-15, 1392/01/26
Registrant information
Name
Sharareh Ghobadi
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 12 3222 8288
Email address
ghobadi.sh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences.
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of prophylactic Magnesium in functional outcome of patients with migraine headache
Public title
The effect of Magnesium in migraine prophylaxis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with history of moderate or severe migraine headache with or without aura.
Exclusion criteria:
Patient lesser than 15 and more than 50 years old. Women with menstrual migraine; history of active peptic ulcer and severe abdominal discomfort; history of diabetes mellitus; asthma; severe depression; heart failure; Pregnancy; Lactation and patients who suffered from other headaches except migraine.
Age
From 15 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
110
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 committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Esfand St, Golestan Blvd.
City
Ahvaz
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
eth-331
Health conditions studied
1
Description of health condition studied
Migraine headache
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Frequency of headache in month
Timepoint
At admission time,after one month and after 3 month
Method of measurement
Questionnaire form
Secondary outcomes
1
Description
MIDAS score
Timepoint
At the admission, and after 3 month
Method of measurement
Questionnaire form
Intervention groups
1
Description
Intervention1: The patients treat with Propranolol (tablet 20 mg, manufactured by Rooz Daru Company) and Magnesium oxide (tablet 250 mg, manufactured by Abidi Company).
Category
Treatment - Drugs
2
Description
Intervention 2: The patients treat with Propranolol (tablet 20 mg, manufactured by Rooz Daru company) and placebo (same Magnesium tablet, contain lactose, manufactured by Ahvaz College of pharmacy).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology Department, Golestan Hospital
Full name of responsible person
Sharareh Ghobadi, MD
Street address
Nosrat St, Golestan Blvd, Golestan Hospital
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Ahvaz University of Medical Sciences
Full name of responsible person
Mostafa Feghhi, MD
Street address
Esfand St, Golestan Blvd
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Ahvaz University of Medical Sciences
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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Sharareh Ghobadi, MD
Position
Resident of Neurology
Other areas of specialty/work
Street address
Esfand St, Golestan Blvd
City
Ahvaz
Postal code
Phone
+98 61 1374 3012
Fax
Email
ghobadi.sh@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Seyed Ehsan Mohammadianinejad,MD
Position
Associated Professor
Other areas of specialty/work
Street address
Esfand St, Golestan Blvd
City
Ahvaz
Postal code
Phone
+98 61 1374 3012
Fax
Email
ehsan-neuro @yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Sharareh Ghobadi,MD
Position
Resident of Neurology
Other areas of specialty/work
Street address
Esfand St, Golestan Blvd
City
Ahvaz
Postal code
Phone
+98 61 1374 3012
Fax
Email
ghobadi.sh@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)