ankylosing spondylitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years old (including 18 & 65 years old), gender is not limited; 2. Meet the diagnostic criteria of axial spondyloarthritis recommended by ASAS in 2009; 3. Meet the Chinese medicine diagnostic criteria of kidney deficiency and cold syndrome; 4. CT examination of sacroiliac arthritis grades ? (A) to ? (B) (both inclusive); 5. Human leukocyte antigen B27 (HLA-B27) positive; 6. Voluntarily participate in this clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have received Chinese medicines other than salazosulfapyridine for the treatment of this disease, chemical drugs (such as methotrexate, leflunomide, hydroxychloroquine, cyclophosphamide, etc.), opioid analgesic drugs (such as morphine, etc.), JAK inhibitor drugs (such as tofacitabine, etc.), and all glucocorticosteroids in 4 weeks prior to the enrollment; 2. 8 weeks prior to enrollment has received spinal or joint surgical treatment; 3. Use of biologics with therapeutic effects on spondyloarthritis within 12 weeks prior to enrollment; 4. CT suggesting loss of sacroiliac joint space or spinal ankylosis; 5. Confirmed concomitant other rheumatic immune system diseases or immunodeficiency syndromes, such as active ulcerative colitis, psoriasis and uveitis; 6. Those who have reproductive requirements within six months; 7. Pregnant or lactating women; 8. Suspected or confirmed drug addiction, drug abuse, alcoholism; 9. Within 3 months prior to the trial or are participating in a clinical trial; 10. Serious heart, liver, kidney, brain, mental, neurological disorders that affect informed consent or adverse event expression or observation; abnormal liver function (glutamic or alanine aminotransferase level higher than the upper limit of normal value); abnormal kidney function (serum creatinine level higher than the upper limit of normal value).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ASAS 20% Response Standard (ASAS20); | — |
Secondary
| Measure | Time frame |
|---|---|
| Erythrocyte sedimentation rate, ESR;C-reactive protein, CRP;Interleukin 6,IL-6;Kidney function test;Liver function test;Sacroiliac CT;HLA-B27; | — |
Countries
China
Contacts
Yunnan Hospital of Traditional Chinese Medicine