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Clinical Trials in Japan / NCT07509775
Recruiting Observational

Integrated Traditional Chinese and Western Medicine for Ankylosing Spondylitis (AS): A Cohort Study Protocol Focusing on Spondyloarthritis Research Consortium of Canada (SPARCC) Scoring System

NCT07509775 · tracked via the Priya Life Science Japan tracker
Sponsor
China-Japan Friendship Hospital
Phase
Observational
Started
2026-01-19
Last updated
2026-04-09

Condition(s) studied

Ankylosing Spondylitis (AS)

Study summary

This study is a multicentre, ambidirectional, observational cohort study. The ambidirectional design incorporates both the collection of retrospective data from the three years prior to enrolment, and a prospective follow-up period of up to two years. The study is designed to evaluate the long-term effects of Integrated Medicine on radiographic progression in patients diagnosed with Ankylosing spondylitis (AS).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 change in Spondyloarthritis Research Consortium of Canada (SPARCC) scores from baseline to 12 months — Review the imaging data from up to three years prior to enrolment and assessed annually in the two-year follow-up period ahead.
    The primary outcome measure assesses the changes in spinal inflammation following one year of Integrated Traditional Chinese and Western Medicine (Integrated Medicine) treatment. Select six consecutive vertebral units showing the most pronounced oedema (each unit comprising the vertebral body and the two inferior vertebral angles) for scoring; the total score ranges from 0 to 30 points. A reduction in the total score before and after treatment (e.g. from 20 to 8 points) indicates that the inflammation has been effectively controlled.

Trial sites (1)

FacilityCityRegionStatus
China-Japan Friendship Hospital Beijing Beijing, China Recruiting

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Other trials for the same condition

Evaluating the Efficacy and Short-Term Prognosis of Integrated Traditional Chinese and Western Medicine for Ankylosing Spondylitis(AS): A Protocol for a Cohort Study Recruiting
The Disease Progression of Chinese Axial Spondyloarthritis in a Real-word Cohort Study Recruiting
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 NCT07509775 on ClinicalTrials.gov ↗ ← All trials in Japan