primary Sjogren syndrome
Conditions
Interventions
Treatment group:Jiedu Tongluo Huashi Decoction+HCQ
Control group:The placebo+HCQ
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: -Age = 18 years old and = 70 years old, regardless of gender -In line with the 2002 European and American Collegiate classification standard of Sjogren syndrome -TCM diagnosis and syndrome differentiation conform to the diagnosis and classification standard of Xerosis (damp-heat syndrome) of "Shanghai Routine diagnosis and Treatment of TCM Diseases and Syndromes" -Within 8 weeks of baseline, only alternative therapy was received, have not received glucocorticoid and immunosuppressive therapy -Understand and agree to participate in this study and sign informed consent
Exclusion criteria
Exclusion criteria: -Combined with other connective tissue diseases -Ophthalmic contraindications for the combination of hydroxychloroquine, such as visual field defects and macular degeneration during fundus examination -Lesions in other organ involvement involving -Combined with cardiac conduction block (PR more than at least 0.2 sec and QRS more than at least 0.08 sec) -Combined with cardiovascular, cerebrovascular, liver, kidney and hematopoietic system severe primary diseases -Allergy and allergic to many medicines -Pregnancy or prepare for pregnancy, and lactation woman -Participants in or currently participating in other clinical trials within 1 month prior to enrollment -AIDS, lymphoma, sarcoidosis, hepatitis C virus infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in ESSPRI relative to baseline at week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| ESSDAI;The secretion of saliva flow without stimulating;Schirmer's test;Corneal fluorescein staining;Breakup time of tear film;ESR;Complement;Immune globulin;RF;Changes in subjective indicators of dry mouth and dry eyes relative to baseline at weeks 4, 8, and 12;Autoimmune-related antibodies; | — |
Countries
China
Contacts
Public ContactBen Li
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed