Clinical Trials in Japan / NCT07556224
Recruiting
Observational
Evaluating the Efficacy and Short-Term Prognosis of Integrated Traditional Chinese and Western Medicine for Ankylosing Spondylitis(AS): A Protocol for a Cohort Study
NCT07556224 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Ankylosing Spondylitis (AS)
Study summary
This study is a multicenter, prospective cohort study designed to systematically evaluate the clinical efficacy of integrated Traditional Chinese and Western Medicine on short-term functional improvement in patients with ankylosing spondylitis, with the Bath Ankylosing Spondylitis Functional Index (BASFI) at 6 months of treatment as the primary outcome measure.
Eligibility
Inclusion Criteria:
* fulfill the 1984 modified New York criteria for ankylosing spondylitis or the 2009 Assessment of SpondyloArthritis International Society (ASAS) classification criteria for axial spondyloarthritis
* age between 18 and 75 years
* sign informed consent.
Exclusion Criteria:
* diagnosis of other autoimmune diseases besides the disease under investigation (e.g., rheumatoid arthritis, Sjögren's syndrome, erythema nodosum, myositis, etc.)
* pregnancy or lactation
* comorbid severe cardiovascular or cerebrovascular diseases, hepatic or renal failure, or malignancy
* spondyloarthritis related to enteropathic arthritis, psoriatic arthritis, or reactive arthritis
* unable to provide data due to mental, language, or similar factors.
Primary outcome measure(s)
- The Bath Ankylosing Spondylitis Functional Index (BASFI) — At baseline, 6 months.
The Bath Ankylosing Spondylitis Functional Index (BASFI) is a 10-item instrument used to measure functional limitation in patients with ankylosing spondylitis. Each item is scored on a 0 to 10 visual analog scale, where 0 indicates easy and 10 indicates impossible. The total score is calculated as the mean of the 10 item scores and ranges from 0 to 10. Higher scores indicate worse functional status.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | Recruiting |
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Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07556224 on ClinicalTrials.gov ↗ ← All trials in Japan