ankylosing spondylitis
Conditions
Interventions
treatment group:Jiejingshudu decoction granules+Celecoxib Capsule
control group:Jiejingshudu decoction granules placebo+Celecoxib Capsule
Sponsors
Xiyuan Hospital of CACMS
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 65 years (inclusive); (2) Conforms to the Western medical diagnostic criteria for the disease, with sacroiliac joint magnetic resonance imaging (MRI) showing clear signs of sacroiliitis; (3) Conforms to the diagnostic criteria for diseases and syndrome types in traditional Chinese medicine (TCM); (4) Ankylosing spondylitis (AS) is in the active phase, defined as Ankylosing Spondylitis Disease Activity Score (ASDAS) = 1.3 or Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) = 4; (5) Answers "Yes" to at least one of the 5 questions in the screening questionnaire, and presents tenderness at any of the enthesial sites involved in the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) (see Appendix 1 of the study protocol); (6) Has signed the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: (1) Patients with hepatic or renal insufficiency (e.g., alanine aminotransferase [ALT] or aspartate aminotransferase [AST] levels exceeding 1.5 times the upper limit of normal [ULN], or serum creatinine [Cr] levels exceeding the ULN; specifically, ALT = 75 U/L, AST = 67.5 U/L, Cr = 104 µmol/L) and other patients deemed unlikely to complete the trial; (2) Pregnant or lactating women, and patients with plans for childbearing within 1 year; (3) Patients with a history of allergy or intolerance to the Chinese herbal pieces in the study prescription or sulfonamide drugs; (4) Patients who are currently using nonsteroidal anti-inflammatory drugs (NSAIDs) or biological agents; or patients who discontinued NSAIDs or biological agents for less than 4 weeks; (5) Patients who are currently using disease-modifying anti-rheumatic drugs (DMARDs) and have not maintained stable types and doses of these drugs for at least 4 weeks; (6) Patients with ankylosing spondylitis who have previously received adequate and regular treatment with celecoxib capsules for 5 days without significant relief of symptoms; (7) Patients with a history of peptic ulcer or gastrointestinal bleeding; (8) Patients with contraindications to magnetic resonance imaging (MRI), such as having internal metal implants or suffering from claustrophobia; (9) Patients who are unable to cooperate with treatment, or other patients considered ineligible by the investigator for any other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ankylosing Spondylitis Disease Activity Score-C-reactive protein; | — |
Secondary
| Measure | Time frame |
|---|---|
| Magnetic resonance imaging of the sacroiliac joint;Sacroiliac joint blood flow grading and Resistance Index index;Maastricht Ankylosing Spondylitis Enthesitis Score;Traditional Chinese Medicine Quality of Life Evaluation Scale;Bath Ankylosing Spondylitis Disease Activity Index;erythrocyte sedimentation rate;C-reactive protein; | — |
Countries
China
Contacts
Public ContactTang JinYang
Xiyuan Hospital of CACMS
Outcome results
None listed