Determining the Effect of Ginger on Preventive Migraine Treatment in Migraine Patients
Design
This study is a clinical trial with control group, parallel groups, double blind, randomized, phase 3, on 108 patients with migraine.
Settings and conduct
patients are divided into two groups (intervention and placebo) to receive medication, and migraine profiles will be assessed at the beginning, end of the first month, and at the end of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria included people 18 to 50 years of age, with a history of migraines with or without aura according to the International Headache Association (IHS) criteria at least one year after diagnosis, moderate to severe migraine (It is defined as: number of headache attacks 2-15 times in a month, attacks with lesser intensity and duration that cause one's disability and disruption in their daily routine).
Intervention groups
Intervention: Daily two ginger pills (500 mg of ginger powder) for 3 months
control:Two placebo tablets (500 mg of starch) daily for 3 months
Main outcome variables
The efficacy of treatment is evaluated based on the frequency of migraine headaches per month, changes in MIDAS score, headache length and severity.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200126046263N1
Registration date:2020-02-18, 1398/11/29
Registration timing:registered_while_recruiting
Last update:2020-02-18, 1398/11/29
Update count:0
Registration date
2020-02-18, 1398/11/29
Registrant information
Name
Foroogh Anjiri zadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3337 8721
Email address
foroogh_anjirizadeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-04, 1398/11/15
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of efficacy of ginger consumption in migraine prophylaxis in patient with migraine
Public title
Investigation of efficacy of ginger consumption in migraine prophylaxis in patient with migraine
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 50 years
Migraine history with or without migraine is according to the International Headache Association (IHS) standard, which is at least one year after diagnosis.
Diagnosis of mild to severe migraine (defined as the number of headache attacks 2 to 15 times a month, or less frequent and severe attacks that cause a person's disability and disruption in their daily routine).
Exclusion criteria:
Non-migraine headaches
Allergy to ginger
Other neurological diseases (stroke, Alzheimer's, etc.)
taking anticoagulants
Pregnant and lactating women
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
The total number of specimens randomly assigned by the process will be divided into two groups by random random blocks and each group will consist of 54 persons. The blocking method will be used for randomization. To do this, a random allocation sequence will be created through the reputable website https://www.sealedenvelope.com/simple-randomiser/v1/lists.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double blind clinical trial (participant, researcher). Ginger and placebo supplements will be packaged in similar boxes, and the researcher and patients will not be informed of the contents of the packs until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2019-12-28, 1398/10/07
Ethics committee reference number
IR.AJUMS.REC.1398.738
Health conditions studied
1
Description of health condition studied
migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
headache
Timepoint
Measurement at baseline (Before the Intervention) and at the end of first and third months after supplementation
Method of measurement
MIDAS
Secondary outcomes
1
Description
Intensity and frequency
Timepoint
Measurement at baseline (Before the Intervention) and at the end of first and third months after supplementation
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Two 500 mg ginger tablets daily for 3 month
Category
Treatment - Other
2
Description
Control group: Two 500 mg placebo tablets daily (containing drug starch) for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Forough Anjiri Zadeh
Street address
Golestan Boulevard Golestan Hospital Neurology Department
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3337 8721
Email
foroogh_anjirizadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mohammad Badvi
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Forooh Anjiri Zadeh
Position
Master student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3337 8721
Email
foroogh_anjirizadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Bijan Helli
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Paramedical Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3337 8721
Email
helli-b@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Forough Anjiri Zadeh
Position
Master of nutrition science
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Paramedical Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3337 8721
Email
foroogh_anjirizadeh@yahoo.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
No - There is not a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document