Actively Recruiting
Evaluating the Efficacy and Short-Term Prognosis of Integrated Traditional Chinese and Western Medicine for Ankylosing Spondylitis: A Prospective Multicenter Cohort Study
Led by China-Japan Friendship Hospital · Updated on 2026-04-29
790
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
C
China-Japan Friendship Hospital
Lead Sponsor
T
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical effectiveness of combining Traditional Chinese and Western Medicine to improve short-term function in patients with ankylosing spondylitis. This multicenter, prospective cohort study focuses on measuring functional improvement using the Bath Ankylosing Spondylitis Functional Index (BASFI) after 6 months of treatment. Participants are divided into two groups: those receiving integrated Traditional Chinese and Western Medicine therapy and those receiving only Western medicine during the follow-up period. The study includes multiple assessments at baseline and at intervals up to 24 months, monitoring disease activity, quality of life, pain levels, inflammation markers, medication adherence, and adverse events. During the study, participants undergo regular evaluations including the BASFI, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Ankylosing Spondylitis Disease Activity Score based on C-reactive protein, and other scales related to mobility and quality of life. Blood tests, pain scores, and medication use are tracked to understand treatment effects and safety over two years. The primary outcome is functional improvement at 6 months, with continued monitoring through 24 months.
CONDITIONS
Brief Title
Evaluating the Efficacy and Short-Term Prognosis of Integrated Traditional Chinese and Western Medicine for Ankylosing Spondylitis(AS): A Protocol for a Cohort Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fulfill the 1984 modified New York criteria for ankylosing spondylitis or the 2009 ASAS classification criteria for axial spondyloarthritis
- Age between 18 and 75 years
- Signed informed consent
You will not qualify if you...
- Diagnosis of other autoimmune diseases besides ankylosing spondylitis (e.g., rheumatoid arthritis, Sjögren's syndrome, erythema nodosum, myositis)
- Pregnancy or lactation
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants are observed over time to collect health and treatment data related to ankylosing spondylitis under different therapy approaches.
Visits at baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment
Trial Site Locations
Total: 1 location
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
Research Team
J
Jiaqi Liu
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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