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

NCT07556224 | Recruiting

• 1 other identifier: 2025-KY-458-1
• Study Type: observational
• Target: 790
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ankylosing Spondylitis (AS)

Outcome Measures

Primary Outcomes (1)

• The Bath Ankylosing Spondylitis Functional Index (BASFI)

  The Bath Ankylosing Spondylitis Functional Index (BASFI) is a 10-item instrument used to measure functional limitation in patients with ankylosing spondylitis. Each item is scored on a 0 to 10 visual analog scale, where 0 indicates easy and 10 indicates impossible. The total score is calculated as the mean of the 10 item scores and ranges from 0 to 10. Higher scores indicate worse functional status.

  At baseline, 6 months.

Secondary Outcomes (11)

• The Bath Ankylosing Spondylitis Functional Index (BASFI)

  At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.

• The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  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)

  At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.

• The Bath Ankylosing Spondylitis Metrology Index (BASMI)

  At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.

• The Ankylosing Spondylitis Quality of Life Scale(ASQoL)

  At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.

Study Arms (2)

exposed group

Participants who receive integrated Traditional Chinese and Western Medicine therapy during the follow-up period.

non-exposed group

Participants who receive only Western medicine therapy during the follow-up period.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Ankylosing spondylitis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• 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
• China-Japan Friendship Hospital: lead
• Henan Province Hospital of Traditional Chinese Medicine (the Second Affiliated Hospital of Henan University of Chinese Medicine): collaborator
• Guangxi Ruikang Hospital: collaborator

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Central Study Contacts

Jiaqi Liu

CONTACT

+86 19804148523; benxiliujiaqi@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 29, 2026
• Study Start: January 19, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)