Status:
COMPLETED
N-acetylcysteine for Primary Sjögren's Syndrome
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Sjögren Syndrome
Sicca Syndrome
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
N-acetylcysteine (NAC) allows the elimination of reactive oxygen species (ROSs) and it has an anti-inflammatory effect. For this reason, NAC has been used and researched for treatment of several disea...
Detailed Description
Study design: This is a prospective, randomized, double-blind controlled study of N-acetylcysteine (600 mg orally every 12 hours in the form of syrup) lasting 12 weeks for the treatment of sicca syndr...
Eligibility Criteria
Inclusion
- Agreement to participate in the study according to signed informed consent.
- Filling the pSS classification criteria.
- Absence of other autoimmune associates systemic diseases.
- EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) \<= 5.
- Prednisone dose \< 20 mg/day at study inclusion.
- Without pilocarpine or cevimeline use at study inclusion.
- No use of N-acetylcysteine for at least 1 month before study inclusion.
Exclusion
- Diabetes, sarcoidosis, previous history of head and neck radiotherapy or iodine therapy, positive serologies for HIV, hepatitis B and C, graft versus host disease, IgG4 (immunoglobulin G4) related disease, and current use of antidepressants tricyclics.
- Current use of biological therapy.
- Current smoking.
- Alcoholism.
- Liver cirrhosis and chronic kidney disease.
Key Trial Info
Start Date :
April 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04793646
Start Date
April 30 2021
End Date
January 21 2025
Last Update
January 27 2025
Active Locations (2)
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1
Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, São Paulo, Brazil, 05403-000
2
Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, Brazil, 05403-000