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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ankylosing Spondylitis (AS)

• Study Type: Observational
• Enrollment (Estimated): 790

Contacts and Locations

• Study Contact: Name: Jiaqi Liu; Phone Number: +86 19804148523; Email: benxiliujiaqi@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Yuqiao Zhang; Phone Number: +86 13520678396; Email: 13661102043@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with Ankylosing spondylitis

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, 12 months, 18 months, and 24 months post-enrollment.
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a 6-item instrument used to measure disease activity in participants with ankylosing spondylitis. It evaluates fatigue, spinal pain, peripheral joint pain and swelling, localized tenderness, and morning stiffness (severity and duration) over the past week. Each item is scored on a 0 to 10 scale, with higher scores indicating greater disease activity. The total BASDAI score is calculated as 0.2 × (Item 1 + Item 2 + Item 3 + Item 4 + (Item 5 + Item 6)/2) and ranges from 0 to 10. Higher scores indicate worse disease activity. A BASDAI score of 4 or higher is commonly considered to indicate high disease activity.	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)	The Ankylosing Spondylitis Disease Activity Score based on C-reactive protein (ASDAS-CRP) is a composite index used to measure disease activity in participants with ankylosing spondylitis. It combines patient-reported items and C-reactive protein (CRP) levels into a single score. The minimum score is 0, with lower scores indicating lower disease activity and higher scores indicating worse disease activity. There is no fixed maximum value because the upper end of the scale depends on the CRP level. ASDAS-CRP disease activity states are defined as inactive disease (<1.3), moderate disease activity (1.3 to <2.1), high disease activity (2.1 to ≤3.5), and very high disease activity (>3.5). Clinically important improvement is defined as a decrease of at least 1.1 units, and major improvement is defined as a decrease of at least 2.0 units.	At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
The Bath Ankylosing Spondylitis Metrology Index (BASMI)	The Bath Ankylosing Spondylitis Metrology Index (BASMI) is an instrument used to measure axial skeletal mobility in participants with ankylosing spondylitis. The total score ranges from 0 to 10. Lower scores indicate better spinal and hip mobility, while higher scores indicate greater limitation of movement and worse axial mobility.	At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
The Ankylosing Spondylitis Quality of Life Scale(ASQoL)	The Ankylosing Spondylitis Quality of Life Scale (ASQoL) is a patient-reported instrument used to measure the impact of ankylosing spondylitis on health-related quality of life. The total score ranges from 0 to 18. Lower scores indicate better quality of life, while higher scores indicate worse quality of life.	At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
Pain Score on the Visual Analogue Scale (VAS)	Pain due to ankylosing spondylitis measured on a 0 to 10 Visual Analogue Scale (VAS) over the past week, where 0 indicates no pain and 10 indicates the most severe pain. Higher scores indicate worse pain.	At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
Serum C-reactive protein (CRP) Level	Serum C-reactive protein (CRP) level measured in blood as a laboratory marker of systemic inflammation in participants with ankylosing spondylitis. Higher CRP levels indicate greater systemic inflammation.	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)	Number of participants who experience adverse events (AEs) or serious adverse events (SAEs), including gastrointestinal reactions, abnormal liver function, abnormal kidney function, and cardiovascular events, as identified from participant-reported symptoms, routine blood and urine tests, fecal occult blood tests, liver and kidney function tests, and electrocardiograms.	At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
Adherence to Prescribed Traditional Chinese Medicine and Western Medicine	Adherence to prescribed traditional Chinese medicine and Western medicine during the 2-year follow-up period, based on participant-reported and recorded medication use.	At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
Time to Discontinuation of Western Medication	Time from the first dose of Western medication to the permanent discontinuation of any Western medication used for ankylosing spondylitis, including non-steroidal anti-inflammatory drugs (NSAIDs) and disease-modifying antirheumatic drugs (DMARDs).	At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
Use of Non-steroidal Anti-inflammatory Drugs (NSAIDs)	Use of non-steroidal anti-inflammatory drugs (NSAIDs) during the study period and changes over time, including NSAID type, dose, frequency, and duration, based on participant-reported and recorded medication use.	At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Collaborators: Shanghai University of Traditional Chinese Medicine; The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine; Beijing Electric Power Hospital; Hunan University of Traditional Chinese Medicine; Guangxi Ruikang Hospital; Shunyi Hospital, Beijing Traditional Chinese Medicine Hospital; Affiliated Hospital of Liaoning University of Traditional Chinese Medicine; Affiliated Hospital of Shandong University of Traditional Chinese Medicine; Henan Province Hospital of Traditional Chinese Medicine (the Second Affiliated Hospital of Henan University of Chinese Medicine); Xi'an Fifth Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Axial Spondyloarthritis; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spinal Diseases; Spondylarthropathies; Ankylosis; Spondylarthritis; Spondylitis; Spondylitis, Ankylosing
• Other Study ID Numbers: 2025-KY-458-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No