ankylosing spondylitis
Conditions
Interventions
The Treatment Arm Combining the New "Cold-Heat Syndrome Differentiation" Protocol with Conventional Western Therapy:The New "Cold-Heat Syndrome Differentiation" Protocol (Oral & Topical) combined Con
other traditional Chinese medicine treatment with Conventional Western Therapy:other traditional Chinese medicine treatment(Oral & Topical) combined Conventional Western Therapy
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
16 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)Age 16-75 years; 2)Meet diagnostic criteria for active Ankylosing Spondylitis;3) Meet diagnostic criteria of the Chinese Medicine "Hunchback Pattern" Syndrome Scale;4) Voluntarily sign informed consent forms;5) Patients regularly using disease-modifying antirheumatic drugs (DMARDs) such as Sulfasalazine (SASP) Methotrexate (MTX) or Leflunomide (LEF) are eligible if maintained on stable doses for =12 weeks before enrollment with unchanged doses during the 12-week study period;6) Patients regularly using biologics or small-molecule targeted drugs are eligible if maintained on stable doses for =12 weeks before enrollment with unchanged doses during the 12-week study period.
Exclusion criteria
Exclusion criteria: 1)Patients not meeting the above inclusion criteria; 2) Pregnant or lactating women individuals with psychiatric disorders severe malnutrition or major impairment in cardiac cerebral renal or hematopoietic systems; 3) Patients with concurrent seronegative spondyloarthropathies or other coexisting rheumatic diseases.1)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of SpondyloArthritis 20% response criterion; | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of SpondyloArthritis 40% response criterion;ankylosing spondylitis quality of life;the MOS item short from health survey;Traditional Chinese Medicine Syndrome Scoring;Bath Ankylosing Spondylitis Measurement Index;the Bath Ankylosing Spondylitis Disease Activity Index;Bath Ankylosing Spondy litis Patient Global Score;Bath Ankylosing Spondylitis Fundation Index;spine pain;Morning stiffness;Night pain VAS score;C-reactive protein;erythrocyte sedimentation Rate;Doctor's overall evaluation VAS score; | — |
Countries
China
Contacts
Public ContactWeiping Kong
China-Japan Friendship Hospital
Outcome results
None listed