This study is a randomized controlled clinical trial, performed in the patients suffering from dyspepsia, in whom Helicobacter pylori infection was detected by endoscopic method, serology, and urease breathe test with C14. These 140 patients were randomly divided into equal groups. The patients in the first group ( control) were treated by omeprazole capsule 20 mg BID, Amoxicillin capsule 1 gr BID, clarithromycin tablet 500mg BID for 14 days; while the patients in the second group were treated by omeprazole capsule 20 mg for 14 days, Amoxicillin capsule 1 gr BID for 5 days, then clarithromycin tablet 500 mg and Tinidazole tablet 500 mg BID for other 5 days. 4-6 weeks after the treatment, we compared the eradication of H.pylori between groups by urease breathe test with C14 and evaluated the effectiveness of the treatment regimen in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104226030N5
Registration date:2011-07-08, 1390/04/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-07-08, 1390/04/17
Registrant information
Name
Bahram Garmrudi nejhad rostamy
Name of organization / entity
Hamedan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0704
Email address
b.garmrudi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice- chancellor for research of Hamedan university of medical sciences
Expected recruitment start date
2011-02-20, 1389/12/01
Expected recruitment end date
2011-08-23, 1390/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of standard triple drugs therapy and sequential regimen for Helicobacter- pylori eradication
Public title
Comparison of standard triple drugs therapy and sequential regimen for Helicobacter- pylori eradication
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : patients in whom Helicobacter pylori infection was detected by endoscopic method, serology, and urease breathe test with C14.
Exclusion criteria:
past history of Helicobacter pylori infection treatment , upper gastero- intestinal surgery,
Gasteric cancer,
renal or liver failure,
breast feeding & pregnant woman.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice- chancellor for research of Hamadan university of medical sciences
Street address
Shahid fahmide blv,Hamadan university of medical sciences ,Vice- chancellor for research,
City
Hamadan
Postal code
65178/518
Approval date
2011-02-08, 1389/11/19
Ethics committee reference number
172866/9/35/16/پ
Health conditions studied
1
Description of health condition studied
Dyspepsia
ICD-10 code
K30
ICD-10 code description
Dyspepsia
Primary outcomes
1
Description
Eradication of Helicobacter pylori
Timepoint
4-6 weeks after treatment
Method of measurement
Rate of eradication by Urease breathe test with C14
Secondary outcomes
empty
Intervention groups
1
Description
Patients in the second group (intervention) were treated by omeprazole capsule 20 mg for 14 days, Amoxicillin capsule 1 gr BD for 5 days, then clarithromycin tablet 500 mg and Tinidazole tablet 500 mg BD for other 5 days
Category
Treatment - Drugs
2
Description
The patients in the first group (control) were treated by triple standard therapy (omeprazole capsule 20 mg BID, Amoxicillin capsule 1 gr BID, clarithromycin tablet 500mg BID for 14 days)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid beheshty hospital & private service
Full name of responsible person
Dr Bahram Garmrudi nejhad rostami
Street address
Shahid beheshty hospital, Eeram blvd
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research of Hamadan university of medical sciences
Full name of responsible person
Dr Ali Ghaleiiha
Street address
Shahid Fahmide blvd
City
Hamadan
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 Hamadan 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
Hamadan university of medical sciences
Full name of responsible person
Dr Bahram Garmrudi Nejhad Rostami
Position
Resident of internal medicine
Other areas of specialty/work
Street address
Shahid beheshty hospital, Eram blvd
City
Hamadan
Postal code
6517953371
Phone
+98 81 1838 0704
Fax
+98 81 1838 0098
Email
b.garmrudi@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan university of medical sciences
Full name of responsible person
Dr Bahram Garmrudi Nejhad rostami
Position
Resident of internal medicine
Other areas of specialty/work
Street address
Shahid beheshty hospital, Eram blvd
City
Hamadan
Postal code
6517953371
Phone
+98 81 1838 0704
Fax
+98 81 1838 0098
Email
b.garmrudi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan university of medical sciences
Full name of responsible person
Dr Bahram Garmrudi nejhad rostami
Position
Resident of internal medicine
Other areas of specialty/work
Street address
Shahid beheshty hospital, Eram blvd
City
Hamadan
Postal code
6517953371
Phone
+98 81 1838 0704
Fax
+98 81 1838 0098
Email
b.garmrudi@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)