Efficacy of coenzyme Q10 in prophylaxis of migraine headache
Design
In this research, 112 eligible patients referring to migraine headache are investigated. Then, patients are randomly divided into two control and intervention groups.the control group takes propranolol and the intervention group take propranolol and Co Q10 (100 mg). after 3 months the groups are investigated by symptoms like headache severity, frequency, duration, and vomiting.
Settings and conduct
This is a double blind study. Participants are the patients with migraine headache who will refer to Imam Reza Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with migraine headache (adults); Over 18 years old
Exclusion criteria: Patients with pregnancy and have serious disorder that interaction with treatment of migraine
Intervention groups
112 eligible patients will randomly divided into control and intervention groups. The control group takes propranolol and the intervention group take propranolol and Co Q10 (100 mg). after 3 months the groups are investigated by symptoms like headache severity, frequency, duration, and vomiting.
Main outcome variables
Prevention of migraine headaches
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171112037413N1
Registration date:2018-01-07, 1396/10/17
Registration timing:registered_while_recruiting
Last update:2018-01-07, 1396/10/17
Update count:0
Registration date
2018-01-07, 1396/10/17
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 914 218 1943
Email address
elahe.hosseinpour@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-21, 1396/09/30
Expected recruitment end date
2018-08-22, 1397/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of coenzyme Q10 in prophylaxis of migraine headache
Public title
Efficacy of coenzyme Q10 in prophylaxis of migraine headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
migraine headache
Exclusion criteria:
Pregnancy
serious disorders that have interaction with treatment of migraine
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
by supervisor
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
Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2017-11-15, 1396/08/24
Ethics committee reference number
IR.KUMS.REC.1396.433
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Severity, frequency, and duration of headache; nausea and vomiting; photophobia; Phonophobia
Timepoint
at the beginning of investigation and after 3 month
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Co Q10-100mg
Category
Treatment - Drugs
2
Description
Control group: Propranolol (10 mg)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Hadi Gharabaghian Azar
Street address
Parastar Boulevard
City
kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83 3427 6301
Email
h_azar2001@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Kurosh Hamzei
Street address
Shahid Beheshti Boulevard
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
src_research@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Elahe Hosseinpour
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Imam Reza Hospital Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715736763
Phone
+98 83 3429 0775
Email
elahe.hosseinpour@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Hadi Gharabaghian Azar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Imam Reza Hospital - Parastar Boulevared
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83 3427 6306
Email
h_azar2001@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Elahe Hosseinpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Imam Reza Hospital - Parastar Boulevared
City
Kermanshah
Province
Kermanshah
Postal code
6715736763
Phone
+98 83 3429 0775
Email
elahe.hosseinpour@kums.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