Screening | Treatment period | Follow-up period | ||||
---|---|---|---|---|---|---|
Visit 1 | Run-in period (visit 2) | 12 weeks (visit 3) | 24 weeks (visit 4) | 12 weeks (visit 5) | 24 weeks (visit 6) | |
Informed consent | X | |||||
Inclusion/exclusion criteria | X | |||||
Demographic data | X | |||||
Medical history | X | |||||
Concomitant medications | X | |||||
Tongue and pulse condition in TCM | X | X | X | X | X | X |
Vital signs | X | X | X | X | X | X |
12-lead ECG | X | X | X | |||
Complete blood count, urine and stool tests | X | X | X | |||
Liver and renal function tests | X | X | X | |||
Coagulation function test | X | X | X | |||
Adverse event evaluation | X | X | X | X | ||
Dispense drug | X | X | X | X | X | |
Primary endpoint | X | X | X | X | ||
Secondary endpoint | X | X | X | X | ||
Cardiac function | X | X | X | |||
hs-CRP | X | X | X | |||
Lipid panels | X | X | X | |||
QLR score | X | X | X | X | X | |
SF-36 score | X | X | X | X | X | |
TCM syndrome score | X | X | X | X | X |