Investigating the effect of adding L-carnitine supplement to migraine prophylaxis treatment on the symptoms and signs of migraine headaches in patients referred to the neurology clinic of Allameh Bohloul Gonabadi Hospital.
Design
Parallel group, double blind, randomized controlled trial in phase 2 and sample size of 48. Randomization was done using permutation block with size of 4.
Settings and conduct
This interventional study will be conducted as a prospective, Single-center trial. 48 patients with migrain admitted to Bohlool hospital will be selected. All patients who meet the eligibility criteria with informed consent will receive l-carnitin or placebo.The control and intervention groups are marked with two codes A and B, and the outcome evaluation physician and the analyst will not be aware of the nature of these two groups for data analysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria :Informed consent, Migraine with or without aura, Having 2 or more migraine attacks per month.
Exclusion criteria: Absence of kidney or liver disease, Pregnancy, breastfeeding.
Intervention groups
The intervention group and control group includes patients with migraine. The intervention group was treated for one month with the standard migraine prophylaxis treatment + 500 mg L-carnitine tablets of Kharazmi company, crushed and placed inside the capsule, one daily.
In the control group, capsules with the same color and shape as the test group are added once a day to routine migraine prophylaxis treatment for one month.
Main outcome variables
Number of days with moderate to severe headache lasting more than 4 hours or treated with usual treatments, Severity of headache on days with headache,Doses of analgesics and triptans
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200418047116N3
Registration date:2023-09-10, 1402/06/19
Registration timing:prospective
Last update:2023-09-10, 1402/06/19
Update count:0
Registration date
2023-09-10, 1402/06/19
Registrant information
Name
Negar Shafaei bajestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5723 6833
Email address
shafaei.n@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-03-05, 1402/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of adding L-carnitine supplement to migraine prophylaxis treatment on the symptoms and signs of migraine headaches.
Public title
Investigating the effect of adding L-carnitine supplement to migraine prophylaxis treatment
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Signed informed consent
Migraine with or without aura according to the International Classification of Headache Disorders
Having 2 or more migraine attacks per month during the past 3 months
Migraine onset before age 50
BMI (kg/m2) between 18 and 35
Exclusion criteria:
Absence of kidney disease or reduced kidney function and liver cirrhosis
No previous use of L-carnitine
No use of ≥ 3 prophylactic medications against migraine during the past 5 years
No alcohol or illegal drug addiction
Not having asthma or vascular disease, arterial lameness
Pregnancy, breastfeeding
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
In the current study, patients with migraine referred to the neurology clinic of Allameh Bohloul Gonabadi Hospital were selected using available sampling technique. If they want to participate in the study and meet the entry criteria, written and informed consent will be obtained from them. Then, in order to assign the patients to two intervention and control groups, he used the method of quadruple permutation blocks in such a way that first six possible states of the blocks (BAAB, ABBA, BABA, BBAA, ABAB, AABB) were listed and to each block one number of One to six will be allocated and will be used for four patients. Then, a number between one and six is randomly selected using the random number table, and then people are assigned to the control group (A) and the intervention group (B) based on the block corresponding to the selected number. It will continue until the end of the sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the intervention group, L-carnitine tablets of 500 mg once a day will be crushed and placed inside the capsule and will be added to the routine migraine prophylaxis treatment. . In the control group, routine prophylaxis treatment and identical placebo are used instead of L-carnitine. People in both the intervention and control groups will receive the necessary training from the researcher about the objectives of the study, the benefits of studying how and how much to consume L-carnitine, the exclusion criteria, and the duration of the intervention. did
The control and intervention groups are marked with two codes A and B, and the outcome evaluation physician and the analyst will not be aware of the nature of these two groups for data analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Imam Khomeini Street, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691615147
Approval date
2023-01-09, 1401/10/19
Ethics committee reference number
IR.GMU.REC.1401.194
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43.9
ICD-10 code description
Migraine, unspecified
Primary outcomes
1
Description
Number of days with moderate to severe headache lasting more than 4 hours or treated with usual treatments
Timepoint
Before the intervention and 4 and 8 weeks after the intervention
Method of measurement
check list
Secondary outcomes
1
Description
Number of days with migraine
Timepoint
Before the intervention and 4 and 8 weeks after the intervention
Method of measurement
check list
2
Description
Severity of headache on days with headache
Timepoint
Before the intervention and 4 and 8 weeks after the intervention
Method of measurement
MIGSEV scale
3
Description
Doses of analgesics and triptans
Timepoint
Before the intervention and 4 and 8 weeks after the intervention
Method of measurement
check list
Intervention groups
1
Description
Intervention group: L-carnitine 500 mg tablets of Kharazmi Company are crushed and placed inside the capsule and taken once a day orally for one month to be added to the routine migraine prophylaxis treatment.
Category
Prevention
2
Description
Control group: Capsules similar to the intervention group containing 10 mg of starch once a day orally for one month will be added to the routine migraine prophylaxis treatment.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
neurology clinic of Allameh Bohloul Gonabadi Hospital
Full name of responsible person
Negar shafaei bajestani
Street address
Imam Khomeini Street, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691615147
Phone
+98 51 5722 3514
Email
info@gmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Leila Sadegh Moghadam
Street address
Imam Khomeini Street, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691615137
Phone
+98 51 5722 3513
Email
info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Negar Shafaei Bajestani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Allameh Bohlool Gonabadi Hospital, Vahdat Blvd.,Saadi St.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6833
Email
negar.shafaei89@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Negar Shafaei bajestani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Saadi St., Vahdat Blvd., Allameh Bohlool Gonabadi Hospital
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6833
Fax
Email
negar.shafaei89@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Negar Shafaei bajestani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Saadi St., Vahdat Blvd., Allameh Bohlool Gonabadi Hospital
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6833
Fax
Email
negar.shafaei89@gmail.com
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
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
All data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published
To whom data/document is available
The researchers in university and other scientific institutes.
Under which criteria data/document could be used
Applications can be submitted for any project that is useful for the treatment of patients.
From where data/document is obtainable
Data can be accessible through sending an email to the corresponding author.
negar.shafaei@mail.com
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.