Beneficial effects of N-acetylcysteine on systemic lupus erythematosus disease activityand its associated complications
Design
After selecting patients based on inclusion criteria, patients were randomly divided into two groups randomly
Settings and conduct
All patients were routinely examined and periodically tested at baseline. These tests included cell blood count, kidney and renal function, urine analysis, and laboratory tests for lupus (Anti dsDNA, ANA titer, C3, C4, proteinuria, and CH50) performed in the reference laboratory of Imam Khomeini Hospital employing appropriate and routine methods. according to BILAG and the SLEDAI score disease activity is measured. Duration of follow up is 3 months after treatment. All patients are told to avoid any change in the drug pattern and other nutritional or behavioral habits. It should be noted that a daily allowance dose of multivitamin contained 500 mg of vitamin C and 30 IU of vitamin E in these patients. finally all data are recorded in pre-designed information forms.
Participants/Inclusion and exclusion criteria
The inclusion criteria are: age more than 16 years old; patients with lupus; history of taking prednisone, azathioprine, mycophenolate mofetil and also satisfaction with participation in the study. Exclusion criteria also are pregnant or lactating patients or people with chronic infections, bronchiectasis; last month infections; severe and recurrent infections; smoking; patients with excessive use of antioxidants (daily and without prescription) and acetaminophen; acute SLE flares threatening vital organs, and people in need of treatment with intravenous cyclophosphamide and biological drugs of rituximab and abatacept
Intervention groups
Control group (routine treatment for lopus), intervention group (receiving N acetyl cysteine)
Main outcome variables
The activity of lupus disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181030041500N2
Registration date:2019-07-08, 1398/04/17
Registration timing:retrospective
Last update:2019-07-08, 1398/04/17
Update count:0
Registration date
2019-07-08, 1398/04/17
Registrant information
Name
pooya saeed askari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3281 2464
Email address
p.saeedaskari@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
2014-05-22, 1393/03/01
Actual recruitment end date
2014-09-21, 1393/06/30
Trial completion date
2015-02-19, 1393/11/30
Scientific title
Beneficial effects of N-acetylcysteine on systemic lupus erythematosus disease activityand its associated complications
Public title
Beneficial effects of N-acetylcysteine on systemic lupus erythematosus disease activityand its associated complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 16
Having lupus
History of using prednisone, azathioprine, mycophenolate mofetil
Satisfaction with participation in the study
Exclusion criteria:
Pregnant or lactating patients
Having any disease at the same time
History of chronic infections
Bronchiectasis
Infection in last month
History of severe infections or frequent infections
Smoking
Patients with excessive use of antioxidants (daily and without Prescription) and acetaminophen
Acute SLE flares threatening vital organs
People in need of treatment with intravenous cyclophosphamide
Patients who are candidates for biological drugs rituximab, abatacept
Dissatisfaction for participation in the study
Age
From 16 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Tools used in randomization was table of random numbers.
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 Rafsanjan university of medical sciences
Street address
Central organisation, Emam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2018-08-29, 1397/06/07
Ethics committee reference number
IR.RUMS.REC.1397.100
Health conditions studied
1
Description of health condition studied
Systemic Lupus erythromatosis
ICD-10 code
M32
ICD-10 code description
Systemic lupus erythematosus (SLE)
Primary outcomes
1
Description
The activity of lupus disease
Timepoint
At the beginning of study and 3 months later
Method of measurement
SLEDAI and BILAG scoring protocol
Secondary outcomes
empty
Intervention groups
1
Description
Control group: the patients continue standard drugs protocol
Category
Treatment - Drugs
2
Description
Intervention group: the patients receive 1800 mg NAC ( made by osveh drug company, 600 mg tab ) for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology clinic of Emam khomeini Hospital
Full name of responsible person
Seyed Reza Najafi
Street address
Chamran Highway, Tehran, Tehran province
City
Rafsanjan
Province
Kerman
Postal code
1419733141
Phone
+98 21 6658 1420
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Seyyed Reza Najafi
Street address
Central Organisation of Tehran University of Medical Sciences, Ghods Ave, Keshavarz Blvd.
City
Kerman
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Email
rmo@tums.ac.ir
Grant name
Tehran University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?