Combining Traditional Chinese and Western medicine to improve function in ankylosing spondylitis
Evaluating the Efficacy and Short-Term Prognosis of Integrated Traditional Chinese and Western Medicine for Ankylosing Spondylitis(AS): A Protocol for a Prospective Multicenter Cohort Study
We will test whether combining Traditional Chinese and Western medicine improves how well adults with ankylosing spondylitis can function after six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 790 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | China-Japan Friendship Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07556224 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, prospective observational cohort following adults with ankylosing spondylitis who receive integrated Traditional Chinese and Western medical care at participating hospitals. The primary outcome is change in the Bath Ankylosing Spondylitis Functional Index (BASFI) after six months of treatment. Patients meeting standard diagnostic criteria (modified New York or ASAS) and aged 18–75 will be enrolled and followed for short-term functional outcomes and prognosis. Data collection will include clinical measures, treatment details as delivered in routine care, and safety/comorbidity information to characterize real-world effectiveness.
Who should consider this trial
Good fit: Adults aged 18–75 with axial ankylosing spondylitis who meet the modified New York or ASAS criteria and can give informed consent are the intended participants.
Not a fit: Patients with other autoimmune diseases, pregnancy or lactation, severe cardiovascular/cerebrovascular disease, hepatic or renal failure, malignancy, or non-axial spondyloarthritis forms are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could offer improved short-term physical function and prognosis for patients using a combined TCM and Western treatment strategy.
How similar studies have performed: Previous small trials and observational reports have suggested symptomatic benefit from TCM or integrated approaches in ankylosing spondylitis, but high-quality randomized evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing Municipality
- China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jiaqi Liu
- Email: benxiliujiaqi@163.com
- Phone: +86 19804148523
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.