Item | Run-in period (−14 ± 1) day | Baseline period (−7~0) days | Intervention period (28 ± 4) days |
---|---|---|---|
Basic information | |||
Informed consent | × | ||
Inclusion/exclusion criteria | × | ||
Demographic data | × | ||
Randomization | × | ||
Record medical history and allergy history | × | ||
Record complication and symptom | × | ||
Record concomitant medication | × | ||
Access to the “Doctor Tao” platform | × | ||
Urine pregnancy test | × | ||
Safety assessment | |||
Vital signs and physical examination | × | × | × |
Blood and urine routine examination | × | × | |
Liver function (ALT, AST, AP, TBIL, γ-GT) | × | × | |
Kidney function (SCr, BUN) | × | × | |
Coagulation function (PT, APTT, TT, FIB, INR) | × | × | |
Fasting blood glucose | × | × | |
Efficacy indicators | |||
Stable angina symptom score | × | × | |
Electrocardiogram | × | × | |
Seattle Angina Questionnaire | × | × | |
Nitroglycerin consumption | × | × | × |
Other works | |||
Drug distribution | × | × | |
Drug recycling | × | × | |
Record adverse events and combined medication | × | × | |
Compliance judgement | × | × |