Study to Evaluate the Effect of Qingre Shuji Decoction combined with Guideline-Directed Medical Treatment on the Quality of Life and Clinical Outcomes in Patients with ankylosing spondylitis 
- Conditions
- ankylosing spondylitis
- Registration Number
- ITMCTR2200006555
- Lead Sponsor
- China-Japan Friendship Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
?18–75 years old ;
?Patients met the diagnostic criteria of Western medicine and disease activity, and the VAS score of spinal pain (the second item of BASDAI) was = 40 mm.
?Patients who met the diagnostic criteria of kidney deficiency and dampness-heat syndrome in TCM ;
?voluntary signing of informed consent ;
?Drug cleaning : SASP, methotrexate (MTX), leflunomide (LEF) and other antirheumatic drugs, hormones, biological agents or small molecule targeted drugs were not used more than 1 month before randomization.
?pregnant or lactating women and mental patients with severe malnutrition or severe damage to the heart, brain, kidney and hematopoietic system ;
?patients with other rheumatic diseases ;
?Patients with severe spinal and hip joint dysfunction who needed surgery during this study ;
?Concurrent NSAIDs use contraindications ;
?contraindications for combined use of biological agents.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effective rate of ASAS20 at week 16;
- Secondary Outcome Measures
Name Time Method