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 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 | | √ | | | | | | | |
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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.
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