Comparison of the effect of carnitine supplement with sodium valproate in the prophylactic treatment of patients with migraine
Design
Clinical trial with control group, single blind, randomized, sample size of 80 people
Settings and conduct
All patients who had a definite diagnosis of migraine and had no exit criteria and no other causes associated with headache were single blind and one to the other, so that the first in one group and the other in the other group were divided into two groups
Participants/Inclusion and exclusion criteria
The number of headache attacks is 4 or more in a month
15 to 60 years old
No brain degenerative disease.
No Pregnancy and lactation
they are not alcoholic or drug user
They did not have psychiatric disease or chronic liver or kidney disorders
No chronic consumption of pain killer
They did not use psychedelic drug
Intervention groups
Intervention group L-carnitine and sodium valproate
Main outcome variables
headache severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190702044073N1
Registration date:2019-09-01, 1398/06/10
Registration timing:retrospective
Last update:2019-09-01, 1398/06/10
Update count:0
Registration date
2019-09-01, 1398/06/10
Registrant information
Name
Nazli Barati bagherabad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3162 6000
Email address
nazli.barati@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
2018-12-22, 1397/10/01
Actual recruitment end date
2019-05-22, 1398/03/01
Trial completion date
2019-06-20, 1398/03/30
Scientific title
Comparison of the effect of carnitine supplementation with sodium valproate in the prophylactic treatment of migraine patients.
Public title
Effect of carnitine on migraine prophylaxis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The number of headache attacks is 4 or more in a month
15 to 60 years old
No brain degenerative disease.
No Pregnancy and lactation
they are not alcoholic or drug user
They did not have psychiatric disease or chronic liver or kidney disorders
No chronic consumption of pain killer
They did not use psychedelic drug
Exclusion criteria:
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
80
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method was used individually using random numbers table.
Blinding (investigator's opinion)
Single blinded
Blinding description
All patients who had a definite diagnosis of migraine and had no exit criteria and no other causes associated with headache were single blind and one to the other, so that the first in one group and the other in the other group were divided into two groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Science
Street address
Ghafari Blvd , Birjand university of medical science
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2018-11-12, 1397/08/21
Ethics committee reference number
Ir.bums.REC.1397.229
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
headache severity
Timepoint
At the beginning of the study and one month after taking L-Carnitine
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
duration of headache attack
Timepoint
At the beginning of the study and one month after taking L-Carnitine
Method of measurement
hour
2
Description
Frequency of headache repetition
Timepoint
At the beginning of the study and one month after taking L-Carnitine
Method of measurement
Frequency of headache repetition in one month
3
Description
Age
Timepoint
At the beginning of the study
Method of measurement
year old
4
Description
sex
Timepoint
At the beginning of the study
Method of measurement
male , female
Intervention groups
1
Description
Intervention group:
Category
Treatment - Drugs
2
Description
Intervention group:
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital , Neurology Clinic
Full name of responsible person
Fateme Nayab
Street address
Ghafari Blvd , Valiasr Hospital
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3244 3000
Fax
+98 56 3244 2088
Email
valiasr@bums.ac.ir
Web page address
http://valiasr.bums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Deputy of research and technology
Street address
Ghafari Blvd , Birjand university of medical science
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
public_r@bums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Nazli Barati
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ghafari Blvd , Birjand university of medical science
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
Nazli.barati@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Seyed Mohammad Mousavi Mirzaei
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Ghafari Blvd , Razi hospital
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۴۴۴۷۱
Phone
+98 56 3162 6020
Email
razihospital@bums.ac.ir
Web page address
http://razi.bums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Nazli Barati
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ghafari Blvd , Birjand university of medical science
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
nazli.barati@bums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
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
Title and more details about the data/document
Clinical study report
When the data will become available and for how long
Within 6 months after publishing the results
To whom data/document is available
Scientific and academic researchers
Under which criteria data/document could be used
Use results in other researchو
From where data/document is obtainable
Website of Birjand University of Medical Sciences
What processes are involved for a request to access data/document
Correspondence with university, approval of deputy research and technology