The purpose of this study is evaluation of the effect oral N-acetylcysteine (NAC) on nitrosative stress factors in patients with rheumatoid arthritis. This study is a randomized double blind clinical trial on 52 patients with active rheumatoid arthritis. Patients with active rheumatoid arthritis with Normal renal function(serum creatinine lower than 2) and Normal liver function with Ability of taking oral NAC are included in this study. Patients are divided into intervention group and placebo group. Intervention group will receive 600 mg NAC twice daily for 12 weeks and placebo group will receive placebo for the same duration as an adjuvant beside the standard treatment. NAC is an antioxidant agent. It reduces nitrosative and oxidative stress. At baseline and at the end of the study patients blood samples will be examined to evaluate the nitrosative stress factors.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2017073022965N12
Registration date:2017-08-12, 1396/05/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-12, 1396/05/21
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 of research, Hamedan University of Medical Sciences
Expected recruitment start date
2017-08-21, 1396/05/30
Expected recruitment end date
2018-08-20, 1397/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation of the effect of oral N-acetylcysteine on nitrosative stress factors in patients with rheumatoid arthritis
Public title
evaluation of N-acetylcysteine on nitrosative stress in Rheumatoid arthritis patients
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: Patients with active rheumatoid arthritis; Normal renal function(serum creatinine lower than 2); Ability of taking oral n-acetylcysteine; Normal liver function
exclusion criteria: Renal dysfunction; Liver dysfunction; Active infection; Mental or cognitive problem; Disability of taking oral drug; Taking antioxidant agents or anti-inflammatory drugs in previous month; Patients with other inflammatory diseases; Patients whom experience adverse drug reactions; Pregnant or lactating patients
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Patients are assigned into intervention or placebo groups by block randomization method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, In front of Luna park, Pazhouhesh Cross , Hamadan
City
Hamedan
Postal code
Approval date
2017-07-08, 1396/04/17
Ethics committee reference number
IR.UMSHA.REC.1396.308
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
nitric oxide
Timepoint
at baseline, at the end of study
Method of measurement
serum level
2
Description
Lipid peroxidation
Timepoint
at baseline, at the end of study
Method of measurement
serum level
3
Description
Thiol groups
Timepoint
at baseline, at the end of study
Method of measurement
serum level
4
Description
Total antioxidant capacity
Timepoint
at baseline, at the end of study
Method of measurement
serum level
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: N-acetylcysteine 600 mg twice daily for 12 weeks
Category
Treatment - Drugs
2
Description
control group: Placebo twice daily for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Ahmad Tahammoli Roudsari
Street address
Besat hospital, Shahid Motahari Avenue, Hamedan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Hamadan University of Medical Sciences
Full name of responsible person
Alireza Ahmadi
Street address
Hamedan University of Medical Sciences, In front of Luna park, Pazhouhesh Cross , Hamadan
City
Hamedan
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 of 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
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Mehrpooya
Position
Assistant Professor/ PhD of clinical pharmacy
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, In front of Luna park, Pazhouhesh Cross , Hamadan
City
Hamedan
Postal code
Phone
+98 81 3838 1594
Fax
Email
m.mehrpoya2003@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Mehrpooya
Position
Assistant Professor/ PhD of clinical pharmacy
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, In front of Luna park, Pazhouhesh Cross , Hamadan
City
Hamedan
Postal code
Phone
+98 81 3838 1594
Fax
Email
m.mehrpoya2003@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fateme Yasrebifar
Position
student
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, In front of Luna park, Pazhouhesh Cross , Hamadan
City
Hamedan
Postal code
Phone
+98 21 4473 6694
Fax
Email
fateme.yasrebifar@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)