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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorChina-Japan Friendship Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

790 Participants
are grouped into 2 trial groups

Sponsors and collaborators

China-Japan Friendship Hospital

Lead sponsor

The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine

Collaborator

Guangxi Ruikang Hospital

Collaborator

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Collaborator

Beijing Electric Power Hospital

Collaborator

Hunan University of Traditional Chinese Medicine

Collaborator

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Collaborator

Xi'an Fifth Hospital

Collaborator

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Collaborator

Shanghai University of Traditional Chinese Medicine

Collaborator

Shunyi Hospital, Beijing Traditional Chinese Medicine Hospital

Collaborator