Items | Screening | Baseline | Treatment | Follow-up | |||||
---|---|---|---|---|---|---|---|---|---|
Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Visit 7 | Visit 8 | Visit 9 | |
−24 weeks | 0 weeks | 4 weeks | 8 weeks | 12 weeks | 16 weeks | 20 weeks | 24 weeks | 48 weeks | |
General | |||||||||
Informed consent | × | ||||||||
Inclusion and exclusion criteria | × | ||||||||
Collect general information | × | ||||||||
General physical examination | × | ||||||||
Urine hCG (only women) | × | ||||||||
Medical and drug use history | × | ||||||||
Concomitant disease and treatment | × | ||||||||
Combined medication | × | × | × | × | × | × | × | × | × |
Effectiveness observation | |||||||||
Vital signs | × | × | × | × | × | × | × | × | × |
TCM symptoms | × | × | × | × | × | × | × | × | × |
Pain evaluation | × | × | × | × | × | × | × | × | × |
Renal function (eGFR, Scr, BUN) | × | × | × | × | × | × | × | × | × |
MRI (TKV) | × | × | × | ||||||
Blood electrolytes | × | × | × | × | × | ||||
Urine β2-MG, mALB/Cr, RBP | × | × | × | × | |||||
Safety observation | |||||||||
Blood test # | × | × | × | × | × | ||||
Urine test | × | × | × | × | × | × | × | × | × |
Stool routine and occult blood test | × | × | × | × | × | ||||
Liver function (ALT, AST, γ-GT) | × | × | × | × | × | ||||
Electrocardiogram | × | × | × | × | |||||
Other data | |||||||||
Adverse events | × | × | × | × | × | × | |||
Allocation | × | ||||||||
Drug distribution | × | × | × | × | × | × | |||
Drug recycling | × | × | × | × | × | × | |||
Drug count | × | × | × | × | × | × | |||
Research conclusion | × | × |