Actively Recruiting

Age: 18Years - 75Years
All Genders
ID07509775

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

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

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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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