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

China-Japan Friendship Hospital

Status: Enrolling

Conditions: Ankylosing Spondylitis (AS)

Study type: Observational

Funder types: Other

Identifiers

NCT07509775

2025-KY-458

Details and patient eligibility

About

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).

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

210 participants in 2 patient groups

exposed group

Description:

Participants who receive traditional Chinese medicine (TCM) therapy for more than 60% of the total duration of their prospective follow-up period.

non-exposed group

Description:

Participants who do not receive any TCM therapy.