Sjögren's syndrome
Conditions
Interventions
Treatment group:total glucosides of paeony Capsules
Sponsors
Rheumatology and Immunology Department, Jiangsu Province Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. aged 18-65 years (including borderline values), of either sex, weighing >= 50 kg for men and >= 45 kg for women; 2. meet the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) pSS classification criteria: persons with at least one of the symptoms of dry eyes or dry mouth, i.e., positive for at least one of the following; or persons with suspected SS who show at least one systematic positive result in the SS Disease Activity Index (ESSDAI) questionnaire of EULAR. (1) Intolerable dryness of the eyes on a daily basis for more than 3 months; (2) Repeated gritty sensations in the eyes; need for artificial tears 3 or more times per day; (3) Feeling dry mouth daily for more than 3 months; (4) Frequent drinking of water to help swallow dry food. And the sum of the following 5 scores >=4: (1) Focal lymphocytic infiltration of the lacrimal gland with a focal index of >=1 focus/4 mm^2 is a score of 3; (2) Positive serum anti-SSA antibodies for 3 points; (3) 1 point for at least a monocular corneal staining count score >= 5 or a Van Bijsterveld score >= 4; (4) 1 point for at least a monocular tear secretion test <= 5 mm/5 min; (5) 1 point for unstimulated whole saliva flow rate <= 0.1 ml/min. 3. a score of <=2 for any ESSDAI score during the screening period and a weighted total score of <=13; 4. positive autoantibodies (positive for one of ANA, anti-SSA, anti-SSB, RF); 5. not pregnant and agreeing to use effective contraception throughout the study period; 6. voluntarily sign an informed consent form; 7. be able to communicate well with the investigator and complete the trial in accordance with the protocol.
Exclusion criteria
Exclusion criteria: 1. Secondary Sjogren's syndrome; 2. Suffering from other connective tissue diseases (such as rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, systemic sclerosis, etc.); Or other diseases that may interfere with the diagnostic test results: including head and neck radiotherapy history, active hepatitis C virus infection, AIDS, sarcoidosis, amyloidosis, graft-versus-host disease, and IgG4 related diseases; 3. Allergic to any component of the experimental medication; 4. Have used cholinergic drugs, immunomodulatory/immunosuppressive drugs, glucocorticoids, non steroidal anti-inflammatory drugs, immunoglobulins, biological agents, gland secretion agonists and other drugs, or have used total glucosides of paeony, tripterygium wilfordii and other traditional Chinese patent medicines and simple preparations or Chinese herbal medicines with immunomodulatory effects within the first three months of screening; 5. Have participated in any other clinical trials (including drugs and devices, etc.) within the past 3 months prior to the screening period; 6. Pregnant or lactating women, or screening period blood pregnancy test positive; 7. The researcher believes that there are any factors that are not suitable for participating in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma drug concentration;Improvement of ESSRI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunoglobulin (IgA, IgG, IgM);Complement C3/C4;ESSPRI;ESSDAI;ESR (Erythrocyte Sedimentation Rate);C-reactive protein(CRP);RF;Antinuclear antibodies(ANA) and titers;Schiermer test;Non stimulated saliva flow;Proportion of Th1, Th17, and Treg cells;Expression levels of Th1, Th17, and Treg cell related factors;Proportion of ILC3 cells;gut microbiota;complete blood count;ALT;AST;BUN;Scr; | — |
Countries
China
Contacts
Public ContactLu lu
Rheumatology and Immunology Department, Jiangsu Province Hospital of Chinese Medicine
Outcome results
None listed