Comparison between the effect of Rosuvastatin and Orlept (Sodium Valproate) in Decrease of headaches attack in persons with Migraines
Design
Select people to be in each group will be permutated block randomization. To blind this study given special code to Each patient. Patients are randomly divided into two groups (Each group consists of 20 patients). These samples will be selected from patients referring to the department of neurology at hospital.
Settings and conduct
In this study, samples will be collected according to Goal Based. Patients are divided into two groups of parallel therapy and under therapy for 3 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Patients Age between 15-55 years
Have migraine headaches With or Without a up to 6months before this study
Confirmation of the presence of migraine by the neurologist
There are more than 4 months of attack
Have two or more headache attacks over the past 3 month
Those who have not received sodium valproate within the last six months
Exclusion criteria
Patients with mental illness
Patients with systemic and background diseases such as diabetes, liver or malignant diseases
Pregnant and Lactating women
Desire to quit
See incidence of complications
Intervention groups
Patients are randomly divided into two groups (Each group consists of 20 patients). Treatment in Group one received sodium valproate (500 mg) and Rosuvastatin (20 mg per day) for 12 weeks, and group two received 500 mg of sodium valproate (Orlept) per day at the same time.
Main outcome variables
Migraine Headaches
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180114038369N1
Registration date:2018-03-18, 1396/12/27
Registration timing:registered_while_recruiting
Last update:2018-03-18, 1396/12/27
Update count:0
Registration date
2018-03-18, 1396/12/27
Registrant information
Name
Reyhaneh Tabaraei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3612 2000
Email address
rtabaraii@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-30, 1396/11/10
Expected recruitment end date
2018-04-30, 1397/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effect of Rosuvastatin and Orlept (Sodium Valproate) in Decrease of migraine headaches
Public title
Comparison between the effect of Rosuvastatin and Orlept (Sodium Valproate) in Decrease of migraine headaches
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Those who have not received sodium valproate within the last six month.
Have migraine headaches With or Without a up to 6 month before this study
Confirmation of the presence of migraine by the neurologist
There are more than 4 month of attack
Have two or more headache attacks over the past 3 month
Exclusion criteria:
Patients with mental illness
Patients with systemic and background diseases such as diabetes, liver or malignant diseases
Pregnant and Lactating women
Desire to quit of this study
See incidence of complications
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will also be done using the permutated block randomization method
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind this study, each patient given a special code.
Prescribing medicines in a double-blind manner, the medications are given to the patients by the supervisor of the hospital, in accordance with the codes prescribed in the package.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qom University of Medical Sciences
Street address
Qom University of Medical Science and Health service, Saheli Ave, Qom
City
Qom
Province
Ghoum
Postal code
3716987366
Approval date
2018-01-02, 1396/10/12
Ethics committee reference number
Ir.Muq.Rec.1396.96
Health conditions studied
1
Description of health condition studied
Migraine headaches
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Migraine headache
Timepoint
Follow up these Patient will be done for 3 months.
Method of measurement
The severity of migraine headache is measured by the Visual Analogue Scale (VAS).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment in Group 1 using sodium valproate
Category
Treatment - Drugs
2
Description
Intervention group: Treatment in group two using rosuvastatin tablets
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qom Hospital
Full name of responsible person
Reyhaneh Tabaraei
Street address
Qom
City
Qom
Province
Ghoum
Postal code
3716987366
Phone
+98 25 3612 2000
Email
rtabaraii@muq.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hossein Saghafi
Street address
Qom
City
Qom
Province
Ghoum
Postal code
3716987366
Phone
+98 25 3107 1300
Email
rtabaraii@muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Reyhaneh Tabaraei
Position
Asistance Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Saheli Ave.
City
Qom
Province
Ghoum
Postal code
3716987366
Phone
+98 25 3107 1300
Email
rtabaraii@muq.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Reyhaneh Tabaraei
Position
Asistance professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Saheli Ave.
City
Qom
Province
Ghoum
Postal code
3716987366
Phone
+98 25 3107 1300
Email
rtabaraii@muq.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Reyhaneh Tabaraei
Position
Asistance professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Saheli Ave.
City
Qom
Province
Ghoum
Postal code
3716987366
Phone
+98 25 3107 1300
Email
rtabaraii@muq.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available