Items | Study period | |||||||
---|---|---|---|---|---|---|---|---|
Screening | Baseline | Treatment period | ||||||
Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Visit 7 | Visit 8 | |
−1w | 0w | 4w | 8w | 12w | 16w | 20w | 24w | |
Enrolment | ||||||||
Inclusion criteria | √ | |||||||
Exclusion criteria | √ | |||||||
Informed consent | √ | |||||||
Randomization | √ | |||||||
Interventions | ||||||||
WG (n = 24) | √ | √ | √ | √ | √ | √ | √ | |
WJNSG (n = 48/24) | √ | √ | √ | √ | √ | √ | √ | |
JNSG (n = 24) | √ | √ | √ | |||||
General | ||||||||
Demographic data | √ | |||||||
Symptoms and signs | √ | |||||||
Past medical history and treatment history | √ | |||||||
Complications and drug combination | √ | |||||||
Physical examination (BP, P, R, T) | √ | √ | √ | √ | √ | √ | √ | |
Vital signs | ||||||||
TCM symptoms and signs | √ | √ | √ | √ | √ | √ | √ | √ |
Renal function (SUA, Scr, BUN) | √ | √ | √ | √ | √ | √ | √ | √ |
Laboratory index (fasting insulin, TG, TC, HDL, LDL, blood electrolytes) | √ | √ | √ | √ | √ | √ | √ | |
24-h uric acid in urine | √ | √ | √ | √ | √ | √ | √ | |
Safety data | ||||||||
Routine urinalysis | √ | √ | √ | √ | √ | √ | √ | √ |
Blood routine | √ | √ | √ | √ | √ | √ | ||
Liver function (ALT, AST, γ-GT) | √ | √ | √ | √ | √ | √ | ||
Electrocardiogram | √ | √ | √ | √ | ||||
Stool routine | √ | √ | √ | √ | ||||
Other data | ||||||||
Causes of withdrawal or dropout | √ | √ | √ | √ | √ | √ | √ | |
Safety evaluation | √ | √ | √ | √ | √ | √ | √ | |
Adverse events | √ | √ | √ | √ | √ | √ | √ | |
Analysis | √ | √ | √ | √ | √ | √ | √ |