Actively Recruiting
Integrated Traditional Chinese and Western Medicine for Ankylosing Spondylitis: A Cohort Study Protocol Focusing on Spondyloarthritis Research Consortium of Canada (SPARCC) Scoring System
Led by China-Japan Friendship Hospital · Updated on 2026-04-09
210
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 conducting a multicenter observational cohort study to explore the long-term effects of combining traditional Chinese medicine and Western medicine on radiographic progression in patients diagnosed with Ankylosing Spondylitis (AS). The study includes a retrospective review of data from the three years before enrollment and a prospective follow-up of up to two years. It aims to assess changes in disease activity and spinal inflammation using the Spondyloarthritis Research Consortium of Canada (SPARCC) scoring system and other clinical measures. Participants will be divided into two groups: those who receive traditional Chinese medicine therapy for more than 60% of their follow-up period and those who do not receive any traditional Chinese medicine therapy. The study will review imaging data annually during the two-year follow-up and assess various clinical indices and inflammatory markers at baseline and at regular intervals up to 24 months. During the study, participants will undergo periodic evaluations including imaging assessments, questionnaires measuring functional status and disease activity, quality of life scales, pain assessments, and blood tests for inflammatory markers. Researchers will also monitor treatment adherence, medication use, and adverse events throughout the follow-up period. The primary measure is the change in SPARCC scores from baseline to 12 months, with additional assessments continuing through 24 months to understand disease progression and treatment effects.
CONDITIONS
Brief Title
Integrated Traditional Chinese and Western Medicine for Ankylosing Spondylitis (AS): A Cohort Study Protocol Focusing on Spondyloarthritis Research Consortium of Canada (SPARCC) Scoring System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- 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, liver or kidney failure, or cancer
- 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 - 24 months
Participants are observed over two years with assessments of spinal inflammation and multiple ankylosing spondylitis related outcomes.
Visits at baseline, 6 months, 12 months, 18 months, and 24 months
Trial Site Locations
Total: 1 location
1
China-Japan Friendship Hospital
Beijing, Beijing, China, China, 100029
Actively Recruiting
Research Team
Y
Yuanyuan Zou, Doctor
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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