Protocol summary
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Study aim
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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
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Design
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A clinical trial performing on 62 children with migraine headaches aged 17-17 years who referre to the pediatric clinic of Amir Kabir Hospital in Arak. These children will divided into two equal groups of propranolol and vitamin B6.
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Settings and conduct
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A clinical trial study in which 62 children with migraine headaches aged 17-17 years who referre to the pediatric clinic of Amir Kabir Hospital in Arak will enrolle. These children will divided into two groups, Propranolol and Vitamin B6. The propranolol group will receive propranolol orally 10 mg daily for three months and the vitamin B6 group will receive 40 mg oral vitamin B6 daily for three months.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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Duration of Migraine Headache Attacks - The number of migraine headaches a week - The severity of headache disability
General information
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Reason for update
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- Randomization field: Patients who enter the study will receive one of the first or second treatments according to the decision of the treating physician.
- Blinding field: Due to the impossibility of preparing a placebo, the study will not be blinded.
- Expected end date of sampling field: Sampling has not started yet and will take several months after starting.
- Other fields: Some minor spelling and writing problems.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191104045328N2
Registration date:
2020-01-25, 1398/11/05
Registration timing:
registered_while_recruiting
Last update:
2021-02-08, 1399/11/20
Update count:
1
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Registration date
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2020-01-25, 1398/11/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-12-06, 1398/09/15
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Expected recruitment end date
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2021-09-06, 1400/06/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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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
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 7 years old to 17 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
62
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-09-29, 1398/07/07
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Ethics committee reference number
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IR.ARAKMU.REC.1398.186
Health conditions studied
1
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Description of health condition studied
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migrain
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ICD-10 code
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G43
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ICD-10 code description
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Migraine
Primary outcomes
1
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Description
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Duration of Migraine Headache Attacks
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Timepoint
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Measured weekly by the patient himself at baseline and three months after taking the medication
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Method of measurement
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the watch
2
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Description
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The number of migraine headaches a week
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Timepoint
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Measured weekly by the patient himself at baseline and three months after taking the medication
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Method of measurement
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numbers
3
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Description
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The severity of headache disability
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Timepoint
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Measured weekly by the patient himself at baseline and three months after taking the medication
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Method of measurement
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with Pediatric Migraine Disability Assessment Score questionnaire
Intervention groups
1
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Description
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31 patients given oral propranolol 10 mg once daily.The duration of the drug is three months
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Category
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Treatment - Drugs
2
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Description
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Intervention group: 31 patients given oral vitamin B6 40 mg once daily .The duration of the drug is three months
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Arak University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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When the article was out of print.
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When the data will become available and for how long
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After publishing the article
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To whom data/document is available
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University researchers
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Under which criteria data/document could be used
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If there are any further questions
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From where data/document is obtainable
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Dr Fakhreddin Shariatmadari
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What processes are involved for a request to access data/document
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Letter writing should be done with professors and universities.
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Comments
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