The objective of this present study was to comparison the eradication rate of Helicobacter pylori
Between two Furazolidon base triple therapy and clarithromycin based triple therapy
in patients who have infected by H.p.
Infection is proved by positive Rapid Ureas Test in endoscopic procedure.
All patients were divided to 2 groups. First had treated by Furazolidon+omprazol+Amoxicillin for 2 weeks and second group had treated by Clarithromycin+Amoxicillin+omprazol for that same duration. These 2 regimens followed by 4 to 6 weeks taking PPI only.
In sequential 2 weeks they have not taking any drug and then they examined by Urea Breath Test to improve HP was eradicated or not.
At the end findings of 2 groups were comprise together.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013112715566N1
Registration date:2014-04-02, 1393/01/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-02, 1393/01/13
Registrant information
Name
Jeela Agah
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 57 1223 8104
Email address
hamid.safiabadi@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin university of Medical Sciences
Expected recruitment start date
2014-03-11, 1392/12/20
Expected recruitment end date
2014-05-31, 1393/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between(clarithromicin- based and furazolidon- based) triple therapy for Helicobacter Pylori treatment
Public title
furazolidone; a cheap drug for eradication of helicobacter pylori
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient with gastric disorders that infection of HP is proved by endoscopy; he /she should not have surgery of GI system in the past, no smoker, no pregnant and haven't had any history of hemolytic anemia .
Exclusion criteria: have not any interest for going on treatment, who didn't do consumption of regimen correctly ,who had to used NSAIDs or other antibiotic for else reason .
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Ethical Committee of Qazvin University of Medical Sciences
Street address
Qazvin university of medical sciences, research deputy, Bahonar Bvd.
City
Qazvin
Postal code
3435145643
Approval date
2014-03-03, 1392/12/12
Ethics committee reference number
28/20/8499
Health conditions studied
1
Description of health condition studied
Helicobacter pylori induced
ICD-10 code
K25, K30
ICD-10 code description
Gastric ulcer; Dyspepsia
Primary outcomes
1
Description
Urease Breath Test
Timepoint
Before intervention and six weeks after after intervention
Method of measurement
Lab test
Secondary outcomes
empty
Intervention groups
1
Description
Furazolidon 100 mg/Bd
+Amoxicillin 1 gr / Bd +
Omeprazple 20 mg /Bd for 2 weeks for half number of patients and continued 4-6 weeks by acid suppression agents
Category
Treatment - Drugs
2
Description
Clarithromycin 500 mg /Bd +
Amoxicillin 1 g /Bd + omeprazole 20 mg /Bd for 2 weeks for half number of patients and continued 4-6 weeks by acid suppression agents.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat Hospital Specialty clinic Qazvin
Full name of responsible person
Hossein Safiabadi
Street address
Velayat Hospital
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Mahnaz Abbasi
Street address
Qazvin University of Medical Sciences, Bahonar Bld.
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Safiabadi
Position
MD, resident of internal medicine
Other areas of specialty/work
Street address
velayat hospital
City
Qazvin
Postal code
Phone
+98 28 1379 0620
Fax
Email
Hamid.safiabadi@ut.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Ali Akbar Haj Agha Mohammadi
Position
Associate professor
Other areas of specialty/work
Street address
Valayat hospital
City
Qazvin
Postal code
Phone
+98 28 1379 0620
Fax
Email
ahmohammadi@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Safiabadi
Position
MD, resident of internal medicine
Other areas of specialty/work
Street address
Velayat hospital
City
Qazvin
Postal code
Phone
+98 28 1379 0620
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)