Timepoint | Study period | |||||
---|---|---|---|---|---|---|
Screeningstage | T0: 0–1 day Treatment (Baseline) | T1: 4 week treatment | T2: 8 week treatment | T3: 12 week treatment | T4: 1 month after end of treatment | |
Face-to-face meeting | √ | √ | √ | |||
Enrolment | ||||||
Eligibility screening | √ | |||||
Informed consent | √ | |||||
Allocation | √ | |||||
Intervention | ||||||
Wangbi granules/Placebo | √ | √ | √ | √ | ||
Outcomes and measures | ||||||
Basic information | √ | |||||
DAS28 | √ | √ | √ | √ | √ | |
ACR50 | √ | √ | ||||
VAS | √ | √ | √ | √ | √ | |
FS-14 | √ | √ | √ | √ | √ | |
HAQ-DI | √ | √ | √ | √ | √ | |
Symptom score | √ | √ | √ | √ | √ | |
Blood routine | √ | √ | √ | |||
Urine routine | √ | √ | √ | |||
Stool routine | √ | √ | √ | |||
Electrocardiograph | √ | √ | √ | |||
ALT/AST/Scr | √ | √ | √ | |||
ESR/CRP | √ | √ | √ | |||
RF/ACPA | √ | |||||
Blood samples | √ | √ | ||||
Assessment of side effects | √ | √ | √ |