Headache is one of the most common diseases that people can get it in their life-long. Recently there are evidences indicating the role of H. Pylori as a cause of headache. The aim of our study is to investigate the effects of simultaneous treatment of Helicobacter Pylori on reducing symptoms of patients with idiopathic headache. In this double-blind case-control study, 210 patients with idiopathic headache and simultaneous symptoms of dyspepsia were divided randomly into two groups after considering the inclusion and exclusion criteria of the study and with no gender preference. MIDAS questionnaire was completed for both groups to determine the severity of headache and case group received two weeks treatment of Helicobacter Pylori in addition to one month treatment of headache and after one-month treatment period of headache, MIDAS questionnaire was completed again for both groups. Then MIDAS score was compared in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109046056N3
Registration date:2011-09-14, 1390/06/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-09-14, 1390/06/23
Registrant information
Name
Nader Zarinfar
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1224 1411
Email address
zarinfar@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences, Research Council
Expected recruitment start date
2011-02-20, 1389/12/01
Expected recruitment end date
2011-09-22, 1390/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of additional treatment of Helicobacter Pylori infection on the severity of headaches in patients with idiopathic headache
Public title
Additional treatment of Helicobacter Pylori infection on the severity of headaches in patients with idiopathic headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Ideoathic headache
2- Age over 20 years old
3- Dyspepsia
4- IgG against H.pylori over 30u/m
Exclusion criteria:
1- Classic treatment for H.pylori in 6-3 months ago
2- Uses of β-blockers or calcium channel blockers in last month
3- Uses of antipsycotic drugs in last month
4- Uses of antiepilepthic drugs in last month
5- Pregnancy
6- Have controindication to antibiotic against H.pylori
7- Disinclination to continue the study
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
210
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Arak, Alamalhoda ave, Arak University of Medical Sciences
In beginning of the study and the end of month one clinical evaluation
Method of measurement
Patient history and physical exam and MIDAS questionare
Secondary outcomes
1
Description
Failure to treatment
Timepoint
End of treatment
Method of measurement
Clinical AND Serological evaluation
2
Description
Drug side effects
Timepoint
During treatment
Method of measurement
Clinical evaluation
Intervention groups
1
Description
In a case group: Patient received Nortriptyline 10 mg nightly and Sodium valproate 200 mg daily and for dispepsia received omeprazole 20 mg and Bismuth Subcitrate 120mg twice daily, Metronidazole 250mg three times a day and Tetracycline 250mg four times a day.
Category
Treatment - Drugs
2
Description
Control group received Nortriptyline 10 mg nightly and Sodium valproate 200 mg daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valie-Asr Hospital
Full name of responsible person
Dr nader zarinfar,Assistant professor Arak University of Medical Sciences, Infectious disease specia
Street address
Valie-Asr Hospital , Pirozi Ave, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.Davoud Hekmatpour
Street address
Arak University of Medical Sciences , Basij square,Arak
City
Arak
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
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
Arak University of Medical Sciences
Full name of responsible person
Dr Nader Zarinfar
Position
Infectious disease specialist
Other areas of specialty/work
Street address
Department of infection disease,Valie-Asr Hospital,Pirozi Ave.Arak
City
Arak
Postal code
3814957558
Phone
+98 86 1224 1411
Fax
+98 86 1224 1411
Email
zarinfar@arakmu.ac.ir
Web page address
portal.arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Nader Zarinfar
Position
Assistant professor,Infectious disease specialist
Other areas of specialty/work
Street address
Department of infection disease,Valie-Asr Hospital, Pirozi Ave,Arak
City
Arak
Postal code
3814957558
Phone
+98 86 1224 1411
Fax
+98 86 1224 1411
Email
zarinfar@arakmu.ac.ir
Web page address
portal.arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Nader Zarinfar
Position
Assistant professor, Infectious disease specialist
Other areas of specialty/work
Street address
Department of infection disease,Valie-Asr Hospital,Pirozi Ave, Arak
City
Arak
Postal code
3814957558
Phone
+98 86 1224 1411
Fax
+98 86 1224 1411
Email
zarinfar@arakmu.ac.ir
Web page address
portal.arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)