The role of N-acetyl Cysteine in the eradication of H.Pylori
Design
This study will be double-blind and clinical trial. 167 patients with dyspepsia under the endoscopy will enter this study. We will divide in two groups randomly.
Settings and conduct
This study is double-blind and clinical trial. We divide in two groups randomly. Researcher who complete questionnaire and analyzer are blind (double blind).Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome assessor.We will divide in two groups randomly.We treat patients with regime of standard by 4 drugs for 2 weeks in first group. We treat patients with regime of standard by 4 drugs and N-Acetylcysteine 600 milligram every 12 hours for 2 weeks in second group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age over 20 years, they have not already received the eradication regimen, patients who have not taken NAC in the last month
Exclusion criteria: Pregnancy and breastfeeding , nausea and vomiting , lack of cooperation
Intervention groups
We treat patients with regime of standard 4 drugs (Clarithromycin - Amoxicillin - Omeprazole - Bismuth) for 2 weeks in first group. We treat patients with regime of standard 4 drugs and N-Acetylcysteine 600 milligram every 12 hours for 2 weeks in second group.
Main outcome variables
Eradication of Helicobacter infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N103
Registration date:2019-04-08, 1398/01/19
Registration timing:registered_while_recruiting
Last update:2019-04-08, 1398/01/19
Update count:0
Registration date
2019-04-08, 1398/01/19
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-06, 1396/12/15
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The role of N-acetyl Cysteine in the eradication of H.Pylori
Public title
The role of N-acetyl Cysteine in the eradication of H.Pylori
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 20 years
They have not already received the eradication regimen
Exclusion criteria:
Pregnancy and breastfeeding
Nausea and vomiting
Lack of cooperation
Age
From 20 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
167
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random number table in division of groups in two groups A and B.
Randomization method: Simple randomization.
Random unit: Individual.
How to build sequences: First, we set the framework for our statistical society. We started from a table point in a row or column. Given the type of code in the row, we chose the same number of digits. After that, the numbers control the path. We noticed smaller numbers of the statistical community. We have to continue this work so that the number of samples is completed.Even numbers were used for intervention group and odd numbers were used for the control group.
Allocation concealment:Numbered drug containers
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind).Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome assessor.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij Squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.ARAKMU.REC.1396.290
Health conditions studied
1
Description of health condition studied
Dyspepsia
ICD-10 code
K30
ICD-10 code description
Functional dyspepsia
Primary outcomes
1
Description
Eradication Helicobacter infection
Timepoint
4 weeks after treatment
Method of measurement
Urease respiratory test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We treat intervention group 4 drugs (Clarithromycin - Amoxicillin - Omeprazole - Bismuth)(Abidi Co) and N-Acetylcysteine (Ave Sina Co)600 milligram every 12 hours for 2 weeks.
Category
Treatment - Drugs
2
Description
Control group: We treat patients with regime of standard by 4 drugs (Clarithromycin - Amoxicillin - Omeprazole - Bismuth)(Abidi Co) in 2 weeks for first group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Zahedin Kheiri
Street address
Sardasht, Basij squre,Amiralmomenin hospital
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
keiri.z@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Vice Chancellor For Research, Arak University Of Medical Science
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
kheiri.z@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?