Comparison of the effect of vitamin B6 and propranolol on Prevention of relapse of migraine headaches in children aged 7-17 years old referring to the pediatric clinic of Amirkabir Arak Hospital
Comparison of the effect of vitamin B6 and propranolol on Prevention of relapse of migraine headaches in children aged 7-17 years old referring to the pediatric clinic of Amirkabir Arak Hospital
Design
A double-blind clinical trial was performed on 62 children with migraine headaches aged 17-17 years who referred to the pediatric clinic of Amir Kabir Hospital in Arak. These children are divided into two equal groups of propranolol and vitamin B6 using block randomization.
Settings and conduct
A clinical trial is a double-blind study in which 62 children with migraine headaches aged 17-17 years who referred to the pediatric clinic of Amir Kabir Hospital in Arak were enrolled. These children were randomly divided into two groups, Propranolol and Vitamin B6, using a randomized number table. The propranolol group received propranolol orally 10 mg daily for three months and the vitamin B6 group received 40 mg oral vitamin B6 daily for three months.
Participants/Inclusion and exclusion criteria
inclusion criteria :Children with migraine headaches at the age of 17-17 years who are allowed to study by their parents.
Exclusion criteria : Propranolol contraindications, such as difficulty breathing, or wheezing, palms and feet cold, heart rate below 60 per minute, asthma or emphyzema, congestive heart failure, diabetes, hyperthyroidism, depression
Kidney or liver failure
Allergy to Vitamin B 6
Intervention groups
group 1 : 31 patients given oral propranolol 10 mg once daily.
group 2 : Intervention group: 31 patients given oral vitamin B6 40 mg once daily
Main outcome variables
Duration of Migraine Headache Attacks - The number of migraine headaches a week - The severity of headache disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191104045328N2
Registration date:2020-01-25, 1398/11/05
Registration timing:registered_while_recruiting
Last update:2020-01-25, 1398/11/05
Update count:1
Registration date
2020-01-25, 1398/11/05
Registrant information
Name
Amin Haji seyyed hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3366 7583
Email address
amin.medstu@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-06, 1398/09/15
Expected recruitment end date
2020-09-05, 1399/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of vitamin B6 and propranolol on Prevention of relapse of migraine headaches in children aged 7-17 years old referring to the pediatric clinic of Amirkabir Arak Hospital
Public title
Comparison of the effect of vitamin B6 and propranolol on Prevention of relapse of migraine headaches in children aged 7-17 years old referring to the pediatric clinic of Amirkabir Arak Hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with migraine headaches at the age of 17-17 years who are allowed to study by their parents.
Exclusion criteria:
Propranolol contraindications, such as difficulty breathing, or wheezing, palms and feet cold, heart rate below 60 per minute, asthma or emphyzema, congestive heart failure, diabetes, hyperthyroidism, depression
Kidney or liver failure
Allergy to Vitamin B 6
Age
From 7 years old to 17 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random randomization with envelope dividing groups into groups A and B In this method, we selected a number of cards or names as the intervention group and the same number of cards for the control group, and then merged the cards. One card was issued and the assignment was registered, and the card was returned to all other cards after being issued. Then the cards are merged again with the card and we take out another card. This process continues until a random sequence of sample size is obtained.
Blinding (investigator's opinion)
Double blinded
Blinding description
The starch will be made from two medicines tablets and placed in the envelopes of the medicine with two identical tablets. The patient is told to take the medication and there is basically one main pill in each envelope, and the other pill is a placebo similar to another.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی اراک
Street address
Vice chancellor for research, Arak University of Medical Sciences, Basij Square, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2019-09-29, 1398/07/07
Ethics committee reference number
IR.ARAKMU.REC.1398.186
Health conditions studied
1
Description of health condition studied
migrain
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Duration of Migraine Headache Attacks
Timepoint
Measured weekly by the patient himself at baseline and three months after taking the medication
Method of measurement
the watch
2
Description
The number of migraine headaches a week
Timepoint
Measured weekly by the patient himself at baseline and three months after taking the medication
Method of measurement
numbers
3
Description
The severity of headache disability
Timepoint
Measured weekly by the patient himself at baseline and three months after taking the medication
Method of measurement
with Pediatric Migraine Disability Assessment questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
31 patients given oral propranolol 10 mg once daily.The duration of the drug is three months
Category
Prevention
2
Description
Intervention group: 31 patients given oral vitamin B6 40 mg once daily .The duration of the drug is three months
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak Amir Kabir Hospital
Full name of responsible person
Dr fakhreddin shariatmadari
Street address
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
City
arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
shariat.8666@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr mohammad Arjmandzadegan
Street address
Vice chancellor for research, Arak University of Medical Sciences, Basij Square, Arak, Iran
City
arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
arjmandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Fakhreddin Shariatmadari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Vice Chancellor for Education, Amir kabir Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
shariat.8666@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Parsa Yousefi chaijan
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
parsayousefichaijan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Ali Motefakker Azad
Position
pediatrics rezident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
parsayousefichaijan@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
Yes - There is a plan to make this available
Title and more details about the data/document
When the article was out of print.
When the data will become available and for how long
After publishing the article
To whom data/document is available
University researchers
Under which criteria data/document could be used
If there are any further questions
From where data/document is obtainable
Dr Fakhreddin Shariatmadari
What processes are involved for a request to access data/document
Letter writing should be done with professors and universities.