primary Sjogren's syndrome
Conditions
Interventions
Test group:Runzaoyin granule,one sack/time,bid
control group:placebo(5%Runzaoyin component),one sack/time,bid
Sponsors
Xiyuan Hospital, Chinese Academy of traditional Chinese medical science
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: ? Meet the classification criteria of ACR and EULAR primary Sjogren's syndrome in 2016; ? Spleen deficiency and fluid deficiency syndrome conforming to the standard of TCM syndrome differentiation; ? Age 18-70 years; ? Informed and signed informed consent.
Exclusion criteria
Exclusion criteria: ? It belongs to secondary Sjogren's syndrome complicated with other connective tissue diseases (such as rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, etc.); ? Women with family planning during pregnancy, lactation or observation; ? Allergic constitution or allergic to the drug components of the preparation; ? Patients with severe primary diseases such as heart, brain, liver, kidney and hematopoietic system; ? Suspected history of alcohol and drug abuse, or other situations that reduce the possibility of enrollment or complicate enrollment according to the judgment of the researcher, such as frequent changes in the working environment, which is easy to cause loss of follow-up; ? Subjects who have participated or are participating in clinical trials of other drugs within 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ESSPRI; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM syndrome score;Exocrine gland function index;Laboratory indicators(IgA\G\M,C3\C4,ESR,CRP,RF,IL6);ESSDAI; | — |
Countries
China
Contacts
Public ContactKou Qiuai
Outcome results
None listed