1- Determination of the additive therapeutic effect of N acetylcysteine in the treatment of persistent Helicobacter infection. 2- determinate and compare side effect in 2 intervention and control groups
Design
This study is interventional, which patients after signing the consent enter in study and then accidentally one by one take standard treatment or standard with NAC and then results of treatment are compared.
Settings and conduct
The study is performed on the patients who refer to shahid Beheshti hospital and Helal Ahmar clinic in Yasuj and becomes 2 groups for treatment and then are compared.
Participants/Inclusion and exclusion criteria
The patient who used chronically NSAID or corticosteroid or have gastric outlet obstruction or pregnancy or renal failure or gastric cancer or precious surgery or use bismuth in first treatment extract of study and the patient who used chronically NSAID or corticosteroid or have gastric outlet obstruction or pregnancy or renal failure or gastric cancer or precious surgery or use bismuth in first treatment extract of study.
Intervention groups
The patient who had persistent helicobacterand use standard and NAC treatment for it
Main outcome variables
Side effects; stool Ag
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190326043119N1
Registration date:2020-02-28, 1398/12/09
Registration timing:retrospective
Last update:2020-02-28, 1398/12/09
Update count:0
Registration date
2020-02-28, 1398/12/09
Registrant information
Name
Fatemeh Gerist
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 4536
Email address
fagerist2013@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-09-01, 1398/06/10
Actual recruitment start date
2018-08-23, 1397/06/01
Actual recruitment end date
2019-09-01, 1398/06/10
Trial completion date
2019-09-01, 1398/06/10
Scientific title
Evaluation of the additive therapeutic effect of N-acetyl cysteine (NAC)on the treatment of persistent Helicobacter pylori (H.pylori) infection
Public title
Effect of N-acetyl cysteine (NAC) in treatment of persistent Helicobacter infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients who refer to shahid Beheshti hospital and Helal e Ahmar clinic who take one episode treatment of H.pylori and did not respond in endoscopy or noninvasive tests such as urease test or stool Ag who we told them persistent h pylori patient
Exclusion criteria:
The patients who used chronically NSAID or corticosteroid
Have gastric outlet obstruction
Pregnancy
Renal failure
Gastric cancer
Precious surgery
Use bismuth in first treatment extract of the study
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
126
Actual sample size reached:
121
Randomization (investigator's opinion)
Randomized
Randomization description
Random permuted blocks was used for randomization with blocks of the size of that after every 4 patient there was an equal number assigned to each treatment for each block one of the arreagments (ccii ,cici,icci,iicc,good,ciic) was randomly chosen.(c=control,i=intervention)
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
Ethics committee of Yasuj University of Medical Sciences
Street address
Emam Sajad hospitalm, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7541994579
Approval date
2019-01-21, 1397/11/01
Ethics committee reference number
IR.YUMS.REC.1397.117
Health conditions studied
1
Description of health condition studied
Persistent helicobacter infection
ICD-10 code
B99- B99
ICD-10 code description
Certain infectious and parasitic diseases
Primary outcomes
1
Description
Negative response of stool Ag
Timepoint
Stool Ag 4 weeks after treatment
Method of measurement
Stool Ag in labratory
Secondary outcomes
1
Description
Side effects
Timepoint
After 2 weeks treatment
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: which used for treatment them standard and NAC we want to compare treatment ratio in both group which take NAC and did not take that we used NAC 600mg bid for 14 day in intervention group.
Category
Treatment - Drugs
2
Description
Control group: who take standard treatment for persistent helicobacter
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid beheshti hospital. Helal Ahmar clinic .
Full name of responsible person
Dr Farshad Ferydooni
Street address
Emam Sajjad hospital
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7541994579
Phone
+98 74 3322 0165
Email
Fagerist2013@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr Mary oryad
Street address
Emam Sajad hospital yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7541994579
Phone
+98 74 3322 0165
Email
Fagerist2013@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr Farshad Ferydooni
Position
Associate of professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Emam Sajad hospital
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7541994579
Phone
+98 74 3322 0165
Email
Fagerist2013@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr Farshad Fereydooni
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Emam Sajad hospital
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7541994579
Phone
+98 74 3322 0164
Email
Fagerist2013@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr Fatemeh Gerist
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Emam Sajad hospital
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7541994579
Phone
+98 74 3322 0165
Email
Fagerist2013@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD