Evaluating the effects of oral N-acetyl cysteine as a Adjuvant therapy on controling clinical symtoms and serum level of inflammatory biomarkers including IL6,TNF-α, CRP and ESR in rhumatoid arthritis Patients
This study is a randomized, placebo-controlled, double-blind trial in 70 patients with arthritis rheumatoid that referred to Besat hospital of hamedan. Inclusion criteria: Patients with diagnosis of active arthritis rheumatoid; Patients more than 18 years and less than 65 years; Patients with moderate to severe active disease
Exclusion criteria: Patients with active infection; Patients with mild active disease. Patients will be randomly allocated into two groups (intervention and placebo) according to Random number tables. In intervention group, patients in addition to standard regimen for RA will receive NAC 600 mg twice a day for 12 weeks and placebo group will receive standard regimen with placebo. Disease Activity Score, version 28 is based on VAS, ESR and number of involved joints and IL-6,TNF-alfa are evaluated before treatment and after 12 weeks after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015071722965N2
Registration date:2015-11-06, 1394/08/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-06, 1394/08/15
Registrant information
Name
Maryam Mehrpooya
Name of organization / entity
School of Pharmacy,Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3821 8684
Email address
m.mehrpoya@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamadan University of medical Sciences
Expected recruitment start date
2015-01-09, 1393/10/19
Expected recruitment end date
2016-06-08, 1395/03/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of oral N-acetyl cysteine as a Adjuvant therapy on controling clinical symtoms and serum level of inflammatory biomarkers including IL6,TNF-α, CRP and ESR in rhumatoid arthritis Patients
Public title
Effect of N-acetyl cysteine on controling clinical symtoms and inflammatory biomarkers in rhumatoid arthritis Patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with diagnosis of arthritis rhumatoid; Patients more than 18 years and less than 65 years; Patients with moderate to severe active disease
Exclusion criteria: Patients with active infection; Patients with mild active disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Ayatollah kashani,
City
Hamadan
Postal code
Approval date
2015-11-20, 1394/08/29
Ethics committee reference number
IR.UMSHA.REC.1394.266
Health conditions studied
1
Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M06.9
ICD-10 code description
Rheumatoid arthritis, unspecified
Primary outcomes
1
Description
IL-6,TNF-alfa
Timepoint
Baseline, after 12 months
Method of measurement
serum level
Secondary outcomes
1
Description
Assesment of clinical symptoms
Timepoint
Baseline, after 12 months
Method of measurement
Disease Activity Score, version 28 questionnaire
Intervention groups
1
Description
Intervention group: Standard regimen plus NAC 600 mg twice daily for 12 months
Category
Prevention
2
Description
Control group: Standard regimen without NAC
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Street address
Besat hospital,Shahid Motahari Avenue, Hamedan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Hamadan University of Medical Sciences
Full name of responsible person
Alireza Ahmadi
Street address
Hamadan University of Medical Sciences
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Hamadan 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Pharmacy, Hamadan University of Medical Sciences
Full name of responsible person
Maryam Mehrpooya
Position
Assistant Professor
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences,Shahid Fahmide Avenue , Hamedan
City
Hamadan
Postal code
Phone
+98 81 3838 1594
Fax
Email
m_mehrpooya2003@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)