With very high prevalence of Helicobacter pylori infection in developing countries and the high prevalence of headaches migraine aim of this study is whether Helicobacter pylori is a risk factor for migraine? Does treatment and eradication of Helicobacter pylori can reduce the number of migraine attacks and can be approved as a therapeutic approach to be used in patients with migraine? The overall objective of the study: The treatment of Helicobacter pylori infection in the reduction severity and number of monthly attacks, migraine headaches. Application of research results: Helicobacter pylori testing in patients with migraine and eradication in the presence of infection will help treat migraine attacks in these individuals. Neurology outpatient clinic and patients referred to the Farshchian health center neurology clinic with headache were evaluated in terms of Migraine and If meet the International Headache Society criteria for migraine were diagnosed after obtaining the consent, are enrolled and placed under serological test for H. pylori Ig G a non-invasive test, sensitive and specific for detection of Helicobacter pylori. In the case of a positive test results patients entered using the form collects information about age and sex and Headache characteristics, including: the severity of headache attacks (Based on the numbers 1_10), the average monthly number of attacks (Based on the number of attacks per month), Intensify with menstrual(y or n), family history of headache(y or n) get Information. All patients underwent standard four-drug therapy Helicobacter pylori with Omeprazol 20 mg Bid, Bismuth 240 mg Bid, Tetracyclin 500 mg Qid, and Metronidazol 500 mg Bid for four weeks. After 4 weeks of the end of treatment urea breath test to confirm eradication and headache characteristics are investigated. The main outcome variables are: the number of migraine attacks and severity of migraine attacks
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202018896N1
Registration date:2012-05-02, 1391/02/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-05-02, 1391/02/13
Registrant information
Name
Niloufar Hemmati
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1823 2771
Email address
shakhenabat1979@yahoo.com
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2012-01-05, 1390/10/15
Expected recruitment end date
2012-12-30, 1391/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Beneficial effects of helicobacter pylori eradication on severity and frequency of migrane headache
Public title
Beneficial effects of helicobacter pylori eradication on severity and frequency of migrane headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All people with headaches meet the International Headache Society criteria (moderate to severe headache, unilateral, pulsatile; intensified with routine activities with nausea and vomiting associated with photophobia and multiple attacks during 72-4 h).
Exclusion criteria: lack of patient satisfaction; identify other causes of headache during treatment and previous treatment of Helicobacter pylori
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Hamedan University of Medical Sciences Ethics Committee
Street address
Fahmideh .ave
City
Hamedan
Postal code
Approval date
2012-01-05, 1390/10/15
Ethics committee reference number
3586|9|35|16|پ
Health conditions studied
1
Description of health condition studied
Migrane
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura [common migraine]
Primary outcomes
1
Description
The number of migraine attacks
Timepoint
Before and after the standard treatment for H. pylori infection
Method of measurement
the average monthly number of headache attacks (based on number of attacks per month
2
Description
Severity of migraine attacks
Timepoint
Before and after the standard treatment for H. pylori infection
Method of measurement
The severity of headache attacks (on the basis of numbers 10_1)
Secondary outcomes
1
Description
Eradication rate of Helicobacter pylori infection [Helicobacter pylori infection in patients with migraine
Timepoint
After treatment
Method of measurement
Urea breath test to confirm eradication
Intervention groups
1
Description
Standard four-drug protocol for H. pylori eradication was employed with Omeprazol 20 mg Bid, Bismuth 240 mg Bid, Tetracyclin 500 mg Qid, and Metronidazol 500 mg Bid for four weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical center and outpatient neurology clinic of Hamadan Farshchian
Full name of responsible person
Dr. Mazaheri
Street address
Mirzadeh Eshghi ave.
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research of Hamedan University of Medical Sciences
Full name of responsible person
Dr Ali Ghaleiiha
Street address
Fahmideh .ave
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research of Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Niloufar Hhemmati
Position
MD, Resident of Internal Medicine
Other areas of specialty/work
Street address
Shahid Beheshti hospital, Eram blv.
City
Hamedan
Postal code
Phone
+98 81 1838 0703
Fax
Email
shakhenabat1979@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Amir Majlesi
Position
Assistant professor, Gastroenterologist
Other areas of specialty/work
Street address
Shahid Beheshti hospital
City
Hamedan
Postal code
Phone
+98 81 1838 0703
Fax
Email
majlesi200@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Niloufar Hemmati
Position
MD, Resident of Internal Medicine
Other areas of specialty/work
Street address
Shahid Beheshti hospital
City
Hamedan
Postal code
Phone
+98 81 1838 0703
Fax
Email
shakhenabat1979@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)