The objective of this controlled trial was to evaluate the efficacy of adding N- acetylcystein drug to the H. pylori eradication regimen in a sample population in Iranian patients. In this study, patients with dyspepsia who are referred for endoscopy to Imam Reza hospital affiliated to Kermanshah University of Medical Sciences and meet eligibility criteria will be enrolled. The patients referred in even days considered as the study group and after confirmation of H. pylori by rapid urease test and histology will receive the regimen of amoxicillin 1000 mg twice daily + clarithromycin 500mg twice daily + omeprazole 20 mg twice daily and those referred in odd days as the control group will receive the same regimen plus N- acetylcysteine 600 mg twice daily for two weeks. Four weeks after completion of the treatment, the same diagnostic procedures will be repeated in both groups. H. pylori eradication rates and drug side effects will be measured and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108197302N2
Registration date:2011-10-03, 1390/07/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-03, 1390/07/11
Registrant information
Name
Ali Asghar Keshavarz
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1724 4800
Email address
akeshavarz@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences, Vice-chancellor for Research and technology
Expected recruitment start date
2011-09-16, 1390/06/25
Expected recruitment end date
2011-12-16, 1390/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two treatment regimens with and without N-acetyl cysteine for eradication of Helicobacter pylori
Public title
Effect of N- acetyl cysteine on H.Pylori
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having the indications of endoscopy, i.e. age over 50 years with symptoms of dyspepsia, individuals with less than 50 years of age who are resistant to a 4-week treatment with gastric acid inhibitors
Exclusion criteria: not willing to undergo endoscopy; having a history of taking antibiotics, bismuth, or proton pump inhibitors in the two weeks prior to the visit; suffering from severe diseases such as renal failure, heart or liver disease, chronic use of anti-inflammatory medications (either non steroidal or corticosteroids), history of surgery or known cases of extra- intestinal cancer, pregnancy, breast feeding
Age
From 15 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
115
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
Ethic committee in research of vice- chancellor for research and technology, Kermanshah University o
Street address
Shahid Beheshti Boulevard, Kermanshah University of Medical Sciences,vice-chancellor of research and technology
City
Kermanshah
Postal code
Approval date
2009-09-15, 1388/06/24
Ethics committee reference number
21484/42/7/پ
Health conditions studied
1
Description of health condition studied
Dyspepsia
ICD-10 code
K30
ICD-10 code description
dyspepsia
Primary outcomes
1
Description
H.pylori eradication rate
Timepoint
4 weeks
Method of measurement
Urease breath test and histology
Secondary outcomes
1
Description
Drug side effects
Timepoint
4 weeks
Method of measurement
Checklist
Intervention groups
1
Description
Control group: Amoxicillin 1000mg twice daily, clarithromycin 500 mg twice daily,omeprazole 20 mg twice daily plus 600mg single dose of NAC for two weeks.
Category
Treatment - Drugs
2
Description
Intervention group: amoxicillin 1000 mg twice daily, clarithromycin 500 mg twice daily,omeprazole 20 mg twice daily for two weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam reza hospital
Full name of responsible person
Ali Asghar Keshavarz MD
Street address
Emam reza hospital, Kermanshah University of Medical Sciences
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice – Chancellery of Research & Technology Affairs, Kermanshah University of Medical Sciences
Full name of responsible person
Dr Ghadiri,MD
Street address
Shahid Beheshti Boulevard
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice – Chancellery of Research & Technology Affairs, Kermanshah 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
Emam reza hospital, Kermanshah University of Medical Sciences
Full name of responsible person
Ali Asghar Keshavarz
Position
Associate professor
Other areas of specialty/work
Street address
Department of gastroenterology,emam reza hospital
City
Kermanshah
Postal code
Phone
+98 83 1724 4800
Fax
Email
akeshavarz@kuma.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Emam reza hospital, Kermanshah University of Medical Sciences
Full name of responsible person
Ali Asghar Keshavarz MD
Position
Associate professor
Other areas of specialty/work
Street address
Emam reza hospital Department of gastroenterology and hepatology
City
Kermanshah
Postal code
6718936971
Phone
+98 83 1724 4800
Fax
Email
akeshavarz@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ali Asghar Keshavarz MD
Position
Associate professor
Other areas of specialty/work
Street address
Department of gastroenterology and hepatology, emam reza hospital
City
Kermanshah
Postal code
Phone
+98 83 1724 4800
Fax
Email
akeshavarz@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)