Determination the effects of n-acetylcysteine on inflammatory biomarkers and disease activity score (DAS28-ESR) of Rheumatoid Arthritis
Design
A randomized double blind clinical trial with a control, parallel groups will be performed on 76 patients with rheumatoid arthritis in the 3rd phase of the trial within 10 months.
Settings and conduct
Patients with rheumatoid arthritis referred to the outpatient rheumatology clinic of Loghman Hakim Educational Hospital who are eligible to enter the study are randomly divided into DMARDs+placebo or DMARDs+oral n- acetylcysteine. Patients will be followed up at the four-week intervals and will receive free visits and drug in the clinic of rheumatology.
In addition, patient, researcher, clinical caregiver and analyst are blind.
Participants/Inclusion and exclusion criteria
Rheumatoid arthritis patients with a DAS28-ESR >=2.6, no history of consuming antioxidant supplements within last 2 months, no recent infectious disease and patients under treatment with DMARDs
Intervention groups
Patients with inclusion criteria are randomly assigned to either DMARDs+placebo twice daily or DMARDs+oral N-acetylcysteine 600 milligrams twice daily.
Main outcome variables
IL-1, IL-17, DAS28-ESR
patient global assessment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190626044030N1
Registration date:2019-12-25, 1398/10/04
Registration timing:registered_while_recruiting
Last update:2019-12-25, 1398/10/04
Update count:0
Registration date
2019-12-25, 1398/10/04
Registrant information
Name
Faezeh Jamali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0118
Email address
f.jamali@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the Effect of N-acetylcysteine on Inflammatory Biomarkers and Disease Activity Score (DAS28-ESR) of Rheumatoid Arthritis
Public title
N-acetylcysteine in Rheumatoid Arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Rheumatoid arthritis patients with a DAS28-ESR score>=2.6
No history of consuming antioxidant supplements within last 2 months
No change of the type and dose of patient's drugs in the last 1 month
No recent infectious disease
Patients that are under treatment with DMARDs
Exclusion criteria:
Biologic agents therapy in the last 6 months
Patients with concurrent autoimmune, rheumatoid disease and gout
Using other complementary and alternative medicine
Pregnancy and lactation
Any addiction to psychotropic agents and opioids
Uncontrolled hypertension
Active gastrointestinal ulcer
History of severe skin allergy
Consuming nitroglycerin
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
We use simple individual random method in this study.
Blinding (investigator's opinion)
Double blinded
Blinding description
In our study, participants, researchist (clinical pharmacist) and physician are blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran National committee for Ethics in Biomedical Research
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2019-06-12, 1398/03/22
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1398.078
Health conditions studied
1
Description of health condition studied
Rheumatoid arthritis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
IL-1, IL-17, DAS28-ESR, patient global assessment
Timepoint
Base, the end of the fourth week, the end of the eighth week
ESR, Number of tender joints, number of swollen joints, reduced or increased need for oral or injectable corticosteroids
Timepoint
Baseline, at the end of the fourth week, at the end of the eighth week
Method of measurement
Serum level, clinical examination
Intervention groups
1
Description
Intervention group: The routine DMARDs in addition to 600 milligrams of effervescent of n-acetylcysteine(osve pharmaceutical company), twice daily for two months. Before intervention, at the end of first month and second month of consumption, we will take blood sample for the measurement of serum level of IL-1, 17 and ESR. Physical examination for calculate DAS-28 ESR will be done, too.
Category
Treatment - Drugs
2
Description
Control group: The routine DMARDs in addition to effervescent of placebo(osve pharmaceutical company ) ,twice daily for two months. Before intervention, at the end of first month and second month of consumption, we will take blood sample for the measurement of serum level of IL-1, 17 and ESR. Physical examination for calculate DAS-28 ESR will be done, too.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Outpatient Rheumatology Clinic Loghman Hakim Educational Hospital
Full name of responsible person
Faezeh Jamali
Street address
Logman Hakim hospital, Makhsous Ave., Lashgar Intersection
City
Tehran
Province
Tehran
Postal code
1333631151
Phone
+98 21 5541 9423
Email
loghman.hospital@sbmu.ac.ir
Web page address
http://lhmc.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9770
Email
Intl_office@sbmu.ac.ir
Web page address
https://www.sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Jamshid Salamzadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Niayesh Intersection ,Valieasr Ave.
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 2243 9982
Email
j.salamzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Jamshid Salamzadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Niayesh Intersection, Valieasr Ave.
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 2243 9982
Email
j.salamzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Faezeh Jamali
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Niayesh Intersection, Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Fax
Email
f.jamali@sbmu.ac.ir
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