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 period	Per-treatment period		Treatment period					Follow-up period
	−2 week	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 24	Week 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.