Clinical study of Tongdu Shujin decoction in the treatment of ankylosing spondylitis with cold-dampness obstruction type: study protocol for a randomized controlled trial

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: Treatment group:Tongdu Shujin decoction;Control group :Celecoxib capsules and thalidomide tablets ; CONDITION: Ankylosing spondylitis PRIMARY OUTCOME: Visual analogue scale;Bath Ankylosing Spondylitis Disease Activity Index;Bath ANKYLOSING Spondylitis Functional Index; SECONDARY OUTCOME: Erythrocyte sedimentation rate;C‐reactive protein;Spinal range of motion ( including finger‐ground distance, occipital tubercle‐wall distance, Schober test ); INCLUSION CRITERIA: INCLUSION CRITERIA: (1) Western medical diagnostic criteria for AS; (2) TCM dialectic is cold‐dampness obstruction type; (3) 18‐40 years old, male or female; (4) Women of childbearing age proved to be not pregnant after testing, and there was no pregnancy plan during the entire trial period; (5) Not taking any AS treatment drugs in the 1 month period before receiving treatment; (6) Voluntarily participate in this trial and agree to enter the clinical study, sign the informed consent form.
Epistemonikos ID: 287c01e71cdd154d74d490e8c016b1d5b8366b20
First added on: Feb 20, 2024