Review Article

Efficacy and Safety of Wenbu Zhibi Granule in Patients with Ankylosing Spondylitis: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial

Table 3

Schedule of the measures.

Measure time point study periodPer-treatment periodTreatment periodFollow-up period
−2 weekWeek 0Week 2Week 4Week 8Week 12Week 16Week 24Week 48

Enrollment
 Inclusion criteria
 Exclusion criteria
 Informed consent
 Allocation

Interventions
 WZG
 WZG placebo

Assessments
 ASAS40
 BASDAI
 ASAS20
 ASAS5/6
 ASAS partial remission
 SPARCC MRI spine score
 BASFI
 BASMI
 ASDAS
 ASQoL
 ESR, CRP
 Vital signs
 Blood, urine, feces routine
 Liver and kidney function
 Compliance assessments
 AE

WZG: Wenbu Zhibi granule; BASDAI: bath ankylosing spondylitis disease activity index; SPARCC: spondyloarthritis research consortium of Canada; BASFI: bath ankylosing spondylitis functional index; BASMI: bath ankylosing spondylitis metrology index; ASDAS: ankylosing spondylitis disease activity score; ASQoL: ankylosing spondylitis quality of life; ESR: erythrocyte sedimentation rate; CRP: C-reactive protein; AE: adverse events.