ankylosing spondylitis
Conditions
Interventions
test group:Yishenjuanbi prescription
control group:mimic Yishenjuanbi prescription
Sponsors
Zhejiang Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Meet the Western medical diagnostic criteria of AS or axSpA; (2) Meet the TCM diagnostic criteria of TCM paralysis syndrome - renal deficiency and stasis obstruction; (3) Age 18~75 years old, male or female; (4) Body mass index [BMI = weight (kg)/height 2 (m2)] = 18kg/m2; (5) CRP and/or ESR > upper limit of the normal range at baseline, BASDAI score = 4 points; (6) Poor response to single-agent NSAIDs (suboptimal response is defined as: NSAIDs are treated at the recommended dose for = 4 weeks and the investigator judges the efficacy to be suboptimal); (7) If the subject is taking oral NSAIDs or other analgesics (such as acetaminophen or weak opioids), the patient should continue to be on a stable dose for at least 2 weeks = 2 weeks or stop taking the drug for = 2 weeks before enrollment; (8) If the subject is taking DMARDs orally, such as methotrexate, hydroxychloroquine, elotimod or leflunomide, the patient needs to be treated for = 12 weeks before enrollment, and the stable dose lasts for = 4 weeks. If the subjects have used the above drugs in the past, they need to stop taking the drugs for at least 4 weeks before enrollment= Leflunomide needs to be discontinued for = 12 weeks; (9) Subjects voluntarily participate in this trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) drug abuse; (2) Women who are trying to conceive, pregnant or breastfeeding; (3) hypersensitivity to the study drug or any component of the study drug; (4) complete rigidity (fusion) of the spine; (5) Combined with serious cardiovascular and cerebrovascular system, digestive system, respiratory and nervous system diseases; (6) Combined with other inflammatory diseases or autoimmune diseases other than AS; (7) The investigator judges that there are circumstances that affect the safety and efficacy evaluation of the study drug; (8) Use of any of the following drugs or participation in clinical studies: 1) Use of penicillamine, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, thalidomide within 4 weeks before enrollment; For other csDMARDs or systemic immunosuppressants, the time of use is within 4 weeks or within 5 half-lives of the drug before enrollment (whichever is longer); 2) Use of etanercept or etanercept biosimilars or JAK inhibitors (such as tofacitinib, baricitinib) within 4 weeks prior to enrollment; Use of infliximab or infliximab biosimilars within 8 weeks prior to enrollment; Use of adalimumab or adalimumab biosimilars, valimumab, certolizumab, ixekizumab, tocilizumab, Brazilplax within 10 weeks prior to enrollment; Use of secukinumab within 5 months prior to enrollment; Use of rituximab within 1 year prior to enrollment (within 6 months if B-cell levels have returned to pre-treatment levels or normal ranges with rituximab); For bDMARDs, use within 12 weeks prior to enrollment or within 5 half-lives of the drug (whichever is longer); 3) Received botanical preparations or traditional Chinese medicine/proprietary Chinese medicine for the treatment of AS within 4 weeks before enrollment (such as tripterygium wilfordii, white peony glycosides, Sinomenine, etc.); 4) Received intramuscular or intravenous glucocorticoids within 4 weeks prior to enrollment; 5) Received any intra-articular injection therapy (such as glucocorticoids, hyaluronic acid, etc.) within 4 weeks before enrollment; 6) Received systemic therapy with interferon within 4 weeks prior to enrollment; 7) Use of cytotoxic drugs (such as chloramethabil, chlorambucil, cyclophosphamide, etc.); 8) Is using strong opioids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ASAS20 compliance rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ASAS40;ASDAS ;CRP;ESR; mSASSS ;bmd;ß-CTX PINP; | — |
Countries
China
Contacts
Public ContactYasong Li
Zhejiang Provincial People's Hospital
Outcome results
None listed