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Recruiting NCT07556224

Evaluating the Efficacy and Short-Term Prognosis of Integrated Traditional Chinese and Western Medicine for Ankylosing Spondylitis(AS): A Protocol for a Cohort Study

— Observational Ankylosing Spondylitis (AS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Ankylosing Spondylitis (AS). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

This study is a multicenter, prospective cohort study designed to systematically evaluate the clinical efficacy of integrated Traditional Chinese and Western Medicine on short-term functional improvement in patients with ankylosing spondylitis, with the Bath Ankylosing Spondylitis Functional Index (BASFI) at 6 months of treatment as the primary outcome measure.

Primary outcome measures

  • The Bath Ankylosing Spondylitis Functional Index (BASFI) [Time frame: At baseline, 6 months.]
Secondary outcome measures (11)
  • The Bath Ankylosing Spondylitis Functional Index (BASFI) [Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.]
  • The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.]
  • Ankylosing Spondylitis Disease Activity Score based on C-reactive protein (ASDAS-CRP) [Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.]
  • The Bath Ankylosing Spondylitis Metrology Index (BASMI) [Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.]
  • The Ankylosing Spondylitis Quality of Life Scale(ASQoL) [Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.]
  • Pain Score on the Visual Analogue Scale (VAS) [Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.]
  • Serum C-reactive protein (CRP) Level [Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.]
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.]
  • Adherence to Prescribed Traditional Chinese Medicine and Western Medicine [Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.]
  • Time to Discontinuation of Western Medication [Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.]
  • Use of Non-steroidal Anti-inflammatory Drugs (NSAIDs) [Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • China-Japan Friendship Hospital — Beijing

Identifiers

NCT: NCT07556224 · 2025-KY-458-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗