Runzaoyin in the treatment of primary Sjogren's syndrome Clinical observation of spleen deficiency and fluid deficiency syndrome
- Conditions
- primary Sjogren's syndrome
- Registration Number
- ITMCTR2200005628
- Lead Sponsor
- Xiyuan Hospital, Chinese Academy of traditional Chinese medical science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
? 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.
? 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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ESSPRI;
- Secondary Outcome Measures
Name Time Method TCM syndrome score;Exocrine gland function index;Laboratory indicators(IgA\G\M,C3\C4,ESR,CRP,RF,IL6);ESSDAI;