This Randomized clinical trial aimed to compare the effect of 400mg intravenous sodium valproate with 6 mg sub- cutaneous sumatriptan in ninety patients with acute migraine headache attended at Sadughi emergency in Yazd. After taking vital sign, forty five randomly chosen patients receive 400mg sodium valproate, intravenously and other forty five patients receive 6mg sub- coetaneous sumatriptan. Severity of headache was measured by verbal numerical rating scale (zero to 10) before, 30minutes, 1 hour and 2 hours after administration.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108025943N4
Registration date:2011-10-27, 1390/08/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-27, 1390/08/05
Registrant information
Name
Abolghasem Rahimdel Meibidi
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 4001
Email address
rahimdel30142@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research Yazd University of Medical Science
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2012-01-21, 1390/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparisson the effect of sodium valproate and sumatriptan on acute migraine attack
Public title
Sodium valproate and sumatriptan in acute migraine attack
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of acute migraine attack, age between 15 to 50 years old
Exclusion criteria: pregnancy, liver disease, ischemic heart disease, hypertension, receiving ergotamine during past hours prior to the study
Age
From 15 years old to 50 years old
Gender
Both
Phase
N/A
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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd University of Medical Science
Street address
Central University Building, Bahonar Square
City
Yazd
Postal code
Approval date
2011-10-22, 1390/07/30
Ethics committee reference number
92192/1/17/پ
Health conditions studied
1
Description of health condition studied
Migrane
ICD-10 code
G43
ICD-10 code description
Primary outcomes
1
Description
Headache Severity
Timepoint
Mean headache severity of patients,pretreatment,half,one and 2 hours after treatment will be measured
Method of measurement
Based on pain measurement ciriterion,Verbal numerical rating scale ,(from 0 to 10)
Secondary outcomes
empty
Intervention groups
1
Description
Sodium valproate, 400 mg, stat, intravenously
Category
Treatment - Drugs
2
Description
Sumatriptan, 6 mg, stat, subcutaneously
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Dr Ali Mellat Ardekani
Street address
Safaaiyeh
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Ezoddini
Street address
Bahonar Square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Ali Mellat Ardekani
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital- Safaaiyeh
City
Yazd
Postal code
Phone
+98 35 1822 4001
Fax
Email
ali_mellat@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Abolghasem Rahimdel
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital- Safaaiyeh
City
Yazd
Postal code
Phone
+98 35 1822 4001
Fax
Email
rahimdel30142@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ali Mellat Ardekani
Position
Assistant Professor
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
ali_mellat@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)