To compare the effectiveness of furazolidone_based quadruple therapy with claritromycine _based quadruple therapy in eradication of H pylori
Design
Randomized control trial, parallel group, double blind
Settings and conduct
One group receive quadruple regimen with furazolidone_based and another group receive claritromycine_based
Blinding: patients: lack of knowledge about the type of regimens that receive
Investigator: lack of knowledge about the type of patient`s regimens
Participants/Inclusion and exclusion criteria
Inclusion critria: Patients with peptic ulcer, dyspepsia, Gastritis ; with confirmation H pylori
Age more than 18
Exclusin critria: age lesser than 18
Intervention groups
One group receive quadruple regimen with furazolidone_based and another group receive quadruple regimen with claritromycine_based
Main outcome variables
Determine the response of H pylori treatment
General information
Reason for update
Acronym
H pylori (Helicobacter pylori)
IRCT registration information
IRCT registration number:IRCT20171203037734N1
Registration date:2018-06-10, 1397/03/20
Registration timing:prospective
Last update:2018-06-10, 1397/03/20
Update count:0
Registration date
2018-06-10, 1397/03/20
Registrant information
Name
Maryam Lajmirnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 7543
Email address
Lajmirnia.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-01, 1397/08/10
Expected recruitment end date
2019-11-01, 1398/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of based_furazolidone quadruple regimens in comparision with based_claritromycine for eradication of Helicobacter pylori
Public title
Evaluation of two type of quadruple regimens of Helicobacter Pylori
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with peptic ulcer, dyspepsia, Gastritis with confirmation H pylori
Age more than 18
Exclusion criteria:
Age lesser than 18
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
194
Randomization (investigator's opinion)
Randomized
Randomization description
Simple, individual, computer software
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients: lack of knowledge about the type of regimens that receive
Investigator: lack of knowledge about the type of patient`s regimens
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Joundishapoor university of medical science
Street address
Ahvaz, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-05-05, 1397/02/15
Ethics committee reference number
IR.AJUMS.REC.1397.070
Health conditions studied
1
Description of health condition studied
H pylori eradication
ICD-10 code
B96.81
ICD-10 code description
Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere