The aim of research is the study of Effects of forbidding Flatulent and Vaporizer Foods On Migraine. Method of research is before and after interventional study, conducted in a sample size of 49 patients with migraine. Inclusion criteria are 1.all men or women patients were in the range age of 18 to 60 years old, 2.patients that their Migraine headache is confirmed by the neurologist. Exclusion criteria are: 1.patient's unwillingness to continue to participate in the research, 2.detect any incidence of systemic diseases. The intervention is to avoid eating some foods for four weeks. Food ban, contains a list of flatulent and Vaporizer foods that as a list is available to patients. At the beginning of the four-week monitoring period, then at the beginning of the intervention and at the end of the fourth week intervention, patients visit by researcher and study in terms severity, duration, frequency of headaches, quality of life and nutritional status by questionnaires that will be evaluated. The findings will be compared before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120331210N1
Registration date:2017-02-13, 1395/11/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-13, 1395/11/25
Registrant information
Name
Majid Soltanpour Gharibdousti
Name of organization / entity
Medicine Faculty of Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 4055
Email address
dr.m.soltanpour@gmail.com
Recruitment status
Recruitment complete
Funding source
Shahed University
Expected recruitment start date
2016-11-28, 1395/09/08
Expected recruitment end date
2017-02-26, 1395/12/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Iranian traditional medicine-based diet on monthly bouts of headache in Migraineurs
Public title
Food Avoidance of Migraine
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria in the study: a man or woman age 18 to 60 years; confirm the presence of migraine according to the ICHD-III respected by neurologist; No other Neurological diseases and systemic diseases such as diabetes, hypertension, liver failure, renal failure; Non-pregnant patient. Exclusion criteria: patient's unwillingness to continue to participate in the research, planning to get pregnant or to carry a pregnancy test positive; detect any incidence of systemic diseases including liver disease, renal, cardiac and neurological diseases than any migraines during the study; Establish non-compliance with the prohibition of food intake according to criteria.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
49
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medicine Faculty of Shahed University
Street address
Opposite of Imam Khomeiny Shrine
City
Tehran
Postal code
Approval date
2016-11-27, 1395/09/07
Ethics committee reference number
Shahed.REC.1395.134
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Frequency of headaches
Timepoint
Before intervention, One month after intervention initiation
Method of measurement
According to patients notes
2
Description
Duration of headaches
Timepoint
Before intervention, One month after intervention initiation
Method of measurement
According to patients notes
3
Description
Severity of headaches
Timepoint
Before intervention, One month after intervention initiation
Method of measurement
Visual Analouge Scale
4
Description
Analgesic use
Timepoint
Before intervention, One month after intervention initiation
Method of measurement
According to patients notes
Secondary outcomes
1
Description
Midas score
Timepoint
Before intervention, one month after intervention initiation
Method of measurement
Questionnaire
Intervention groups
1
Description
Avoid of eating some foods for four weeks. Food ban, Contains a list of flatulent and Vaporizer foods that as a list is available to patients.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahed Traditional Iranian Medicine Salamatgah
Full name of responsible person
Majid Soltanpour Gharibdousti
Street address
Tim Health care, Third Dashtestan Ave, Shariati Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University of Medical Sciences
Full name of responsible person
Elham Emaratkar
Street address
Opposite of Imam Khomeiny Shrine
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Medicine Faculty of Shahed University
Full name of responsible person
Majid Soltanpour Gharibdousti
Position
Traditional Iranian Medicine Phd Student
Other areas of specialty/work
Street address
Opposite of Imam Khomeiny Shrine
City
Tehran
Postal code
Phone
+98 21 5121 4055
Fax
+98 21 5121 4056
Email
Dr.m.soltanpour@gmail.com, Timshahed@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medicine Faculty of Shahed University
Full name of responsible person
Dr. Elham Emaratkar
Position
Phd Of Iranian Traditional Medicine
Other areas of specialty/work
Street address
Opposite of Imam Khomeiny Shrine
City
Tehran
Postal code
Phone
+98 21 5121 4055
Fax
+98 21 5121 4056
Email
E.Emaratkar@gmail.com, Timshahed@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medicine Faculty of Shahed University
Full name of responsible person
Majid Soltanpour Gharibdousti
Position
Traditional Iranian Medicine Phd Student
Other areas of specialty/work
Street address
Opposite of Imam Khomeiny Shrine
City
Tehran
Postal code
Phone
+98 21 5121 4055
Fax
+98 21 5121 4056
Email
Dr.m.soltanpour@gmail.com, Timshahed@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)