We aim to evaluate the efficacy of NAC in improvement of dyspepsia symptoms in H. Pylori negative patients
Design
In this research, 88 patients with dyspepsia and H. pylori negative with inclusion criteria and not having exclusion criteria referring to Gastroenterology clinics will be included. Patients will be randomly allocated to pantaprazol with or without NAC groups and each patient will be given a specific code.
Settings and conduct
After patients selection, they will be randomly allocated to Pantaprazol with or without NAC groups. Patients in both groups will be treated for 8 weeks and will be evaluated before and after intervention for dyspepsia symptoms according to ROME III criteria and need for endoscopy after treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with dyspepsia and H. pylori negative test. Exclusion criteria: Chronic use of NSAIDs or corticosteroids for more than a month; gastric outlet obstruction diagnosed in endoscopy; pregnancy (due to the complications); chronic kidney disease; GI malignancy; previous gastric surgery; patients with asthma or COPD receiving NAC.
Intervention groups
Patients will receive pantaprazol 40 mg daily with or without NAC 600 mg daily.
Main outcome variables
The main outcomes of the study are change in dyspepsia symptoms according to ROME III criteria and need for endoscopy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170716035126N3
Registration date:2018-02-17, 1396/11/28
Registration timing:prospective
Last update:2018-02-17, 1396/11/28
Update count:0
Registration date
2018-02-17, 1396/11/28
Registrant information
Name
Afshin Habibzadeh
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3352 2391
Email address
a.habibzade@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-06, 1396/12/15
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of N-acetyl cysteine (NAC) in dyspeptic patients and negative Helicobacter pylori infection
Public title
Evaluating the efficacy of N-acetyl cysteine (NAC) in dyspeptic patients and negative Helicobacter pylori infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with the complaint of dyspepsia and negative H. pylori test
Exclusion criteria:
Chronic use of NSAIDs or corticosteroids fro more than a month
Gastric outlet obstruction diagnosed in endoscopy
Pregnancy (due to the side effects)
Chronic kidney disease
GI malignancy
previous gastric surgery
Patients receiving NAC due to asthma or COPD
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized into two groups using random number blocks and using sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the person evaluating the treatment outcome will be blinded to the allocated groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ardabil University of Medical Sciences
Street address
Ardabil University of Medicine Sciences, Daneshgah St.,
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Approval date
2018-01-14, 1396/10/24
Ethics committee reference number
IR.ARUMS.REC.1396.208
Health conditions studied
1
Description of health condition studied
dyspepsia
ICD-10 code
K30
ICD-10 code description
Functional dyspepsia
Primary outcomes
1
Description
Dyspepsia symptoms
Timepoint
Before and 8 weeks after intervention
Method of measurement
Using ROME III criteria
2
Description
Need for endoscopy
Timepoint
8 weeks after intervention
Method of measurement
No change or deterioration of dyspepsia symptoms
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will receive pantaprazol 40 mg and NAC 600 mg daily
Category
Treatment - Drugs
2
Description
Control group: Patients will receive only pantaprazol 40 mg daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ardabil Imam Khomeini Hospital
Full name of responsible person
Moharram Nokhah
Street address
Imam Khomeini Hospital, Ataei Ave.,
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 3352 2083
Email
dr.mnokhah@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Masoud Entezari Asl
Street address
Ardabil University of Medical Science, Daneshgah St.,
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 3352 2083
Email
m.entezari@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Afshin Habibzadeh
Position
Internal medicine resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini hospital, Ataei Ave.,
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3352 2391
Email
afshin.habibzadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Nasser Hajavi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital, Ataei ave.,
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3352 2391
Email
nhajavi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Moharram Nokhah
Position
Internal Medicine Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital, Ataei ave.,
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3352 2391
Email
dr.mnokhah@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available