Comparison of the effect of sodium valproate and sodae capsule on migraine headaches
Design
This study is a double-blind clinical trial. 90 patients with primary migraine included in the study by convenience method will be randomly assigned to either intervention or control groups. Each participant will be assigned a code.
Settings and conduct
This study will be conducted in a clinic and in the personal office of the project partner (Dr. ِDaryoush Afshari and Dr. Masoud Ghiasian). The researcher and study participants will not aware that they are in the intervention group or in the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having more than 3 attacks per month in the last three months, Having more than 3 attacks at the base time, Start migraines at least one year before entering the project, Start migraines before age 50.
Exclusion criteria: Chronic tension headaches or other headaches for more than 15 days a month, Pregnancy and lactation, Patients should not be addicted to alcohol or other illegal substances.
Intervention groups
The intervention group will take one 720 mg sodae capsule made by Boo Ali Daroo Company, with warm water every night before going to bed for three months. The control group will take one 720 mg Sodium Valproate with warm water every night before going to bed for three months.
Main outcome variables
Severity of migraine headache
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200126046272N3
Registration date:2020-09-27, 1399/07/06
Registration timing:registered_while_recruiting
Last update:2020-09-27, 1399/07/06
Update count:0
Registration date
2020-09-27, 1399/07/06
Registrant information
Name
Negin Fakhri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3826 2005
Email address
n.fakhri94@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative survey of the Sodium valproate and Sodae herbal capsule effects on migraine pain
Public title
Comparison of the Sodium valproate and Sodae herbal capsule effects on migraine pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having more than 3 attacks per month in the last three months
Having more than 3 attacks at the base time
Start migraines at least one year before entering the project
Start migraines before age 50
Exclusion criteria:
Chronic tension headaches or other headaches for more than 15 days a month
Pregnancy, lactation
Patients should not be addicted to alcohol or other illegal substances
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method will be performed with 4 blocks. A colleague will be done a randomization plan and write the code for people, and it remains with the project colleague until the end of the study.
First, a list of blocks will be prepared and one number will be assigned to each block, then random numbers will be generated from 1 to 6, and according to these random numbers, the corresponding block will be used, and the list of random allocation of intervention and control will be determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and the participants in this study were kept blind. They have no information about the assignment of individuals to groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Approval date
2020-09-12, 1399/06/22
Ethics committee reference number
IR.KUMS.REC.1399.614
Health conditions studied
1
Description of health condition studied
migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
severity of migraine
Timepoint
Baseline, Three months after the Baseline
Method of measurement
Based on Headache Disability Scale (MIDAS) and Headache Severity Test (HIT6)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will take one 720 mg sodae capsule made by Boo Ali Daroo Company, with warm water every night before going to bed for three months
Category
Treatment - Drugs
2
Description
Control group: The control group will take one 720 mg Sodium Valproate with warm water every night before going to bed for three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital Clinic
Full name of responsible person
Dr Daryoush Afshari
Street address
Bostan Clinic, Imam Reza Hospital, Bagh Abrisham
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3826 2005
Email
afshari_d@yahoo.com
2
Recruitment center
Name of recruitment center
Sina hospital clinic
Full name of responsible person
Dr Masoud Ghiasian
Street address
Hamedan - Mirzadeh Eshghi I St. - Honarsestan St. - Farshchian Hospital
City
Hamedan
Province
Hamadan
Postal code
6516848741
Phone
+98 81 3838 1740
Email
masoud_ghiasian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Booali Daroo pharmaceutical company
Full name of responsible person
Alireza Masoumi
Street address
No. 49, No. 6 Alley, Twenty-meter Angle, Azar Street
City
Qom
Province
Isfehan
Postal code
7935637149
Phone
+98 25 3720 9544
Email
amasumi24@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Booali Daroo pharmaceutical company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
2
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Farid Najafi
Street address
Vice chancellor for research and technology, Building 2, University of Medical Sciences, shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Booali Daroo pharmaceutical company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Negin Fakhri
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
Student Research Committee , School of Public Health, Shahid Bahonar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3826 4447
Email
n.fakhri94@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mansour Rezaei
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
School of Public Health, Dolatabad Boulevard, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3826 4447
Email
mrezaei@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Negin Fakhri
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
Student Research Committee , School of Public Health, Shahid Bahonar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3826 4447
Email
n.fakhri94@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The main implications will be shared after the study is completed.
When the data will become available and for how long
4 month
To whom data/document is available
Upon request, the study results will be made available to other academic researchers.
Under which criteria data/document could be used
People who have the same study and come up with contradictory results that are not rational.
From where data/document is obtainable
Send email updates for documentation.
What processes are involved for a request to access data/document
Documentation will be emailed within a 10-day timeframe.