The purpose of this randomized, double blind trial is to determine the effect of Helicobacter pylori eradication treatment on clinical symptoms improvement of patients with functional dyspepsia. 300 hundred patients with functional dyspepsia are randomly assigned to receive Helicobacter pylori eradication treatment in addition to treatment of functional dyspepsia in intervention group or treatment of functional dyspepsia alone in control group for 2 weeks. Abdominal pain, bloating, and heartburn are measured and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008274017N4
Registration date:2010-09-13, 1389/06/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-09-13, 1389/06/22
Registrant information
Name
Hosseinali Habibinejad
Name of organization / entity
Islamic Azad University of Qom
Country
Iran (Islamic Republic of)
Phone
+98 21 7745 4051
Email address
ghadir@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Qom University of Medical Sciences
Expected recruitment start date
2010-09-02, 1389/06/11
Expected recruitment end date
2011-03-14, 1389/12/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of the effect of Helicobacter pylori eradication treatment on clinical symptoms improvement of patients with functional dyspepsia
Public title
Effect of Helicobacter pylori eradication treatment on treatment of functional dyspepsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: complaining from dyspepsia, presence of functional dyspepsia, positive H.pylori test
Exclusion criteria: organic cause for dyspepsia
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qom University of Medical Sciences
Street address
Saheli Ave
City
Qom
Postal code
Approval date
empty
Ethics committee reference number
263/د
Health conditions studied
1
Description of health condition studied
Functional dyspepsia
ICD-10 code
F45.3
ICD-10 code description
somatoform autonomic dysfunction
Primary outcomes
1
Description
abdominal pain
Timepoint
before treatment, 2 weeks after treatment, 1 month after treatment
Method of measurement
visual analog scale
2
Description
bloating
Timepoint
before treatment, 2 weeks after treatment, 1 month after treatment
Method of measurement
visual analog scale
3
Description
heartburn
Timepoint
before treatment, 2 weeks after treatment, 1 month after treatment