Ankylosing spondylitis (AS)
Conditions
Interventions
Experimental group:Bushen Qiangdu Prescription Oral
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years. 2. Fulfillment of the New York criteria revised by the American Rheumatism Association in 1984; or the diagnostic criteria for axial spondyloarthritis established by the Assessment of SpondyloArthritis International Society in 2009. 3. Meeting the diagnostic criteria for disease activity with a VAS score for spinal pain (the second item of the BASDAI) = 40mm. 4. Compliance with the diagnostic criteria for Dalu disease with kidney deficiency and coldness of the governor vessel in traditional Chinese medicine. 5. Voluntary signing of the informed consent form. 6. Drug washout: Subjects should not have used sulfasalazine (SASP), methotrexate (MTX), leflunomide (LEF), or other disease-modifying antirheumatic drugs, hormones, biological agents, or small-molecule targeted drugs for at least one month prior to randomization. Note: If the answer to any of the above sub-criteria is "no", the subject cannot participate in the study.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, patients with mental illness, those with severe malnutrition, or individuals with severe impairments to the heart, brain, kidneys, or hematopoietic system. 2. Patients with concurrent other rheumatic diseases. 3. Patients with severe functional limitations in the spine or hip joints who require surgery during the study period. 4. Individuals with contraindications to the use of non-steroidal anti-inflammatory drugs (NSAIDs). 5. Patients with contraindications to the use of biological agents. Note: If the answer to any of the above sub-criteria is "yes", the subject cannot participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of ASAS20 at week 16;clinical manifestations;physical examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptoms at week 16;inflammatory markers at Week 16;Syndrome Score in Traditional Chinese Medicine;Ankylosing Spondylitis Quality of Life;clinical information; | — |
Countries
China
Contacts
Public ContactKong Weiping
China-Japan Friendship Hospital
Outcome results
None listed