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Table 4 Time schedule of enrolment, intervention and outcome measures of the trial

From: Wangbi granule as a combination therapy to achieve clinical deep remission in rheumatoid arthritis: protocol for a multicenter, triple-blind, randomised, placebo-controlled trial

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

  

 
  1. DAS28 disease activity score derivative for 28 joints, ACR50 American College of Rheumatology 50% response criteria, VAS visual analogue scale for pain, FS-14 fatigue scale-14, HAQ-DI health assessment questionnaire disability index, ALT alanine aminotransferase, AST aspartate aminotransferase, Scr serum creatinine, ESR erythrocyte sedimentation rate, CRP C-reactive protein, RF rheumatoid factors, ACPA anti-citrullinated protein antibodies