|
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
| |
√
|
√
|
√
|
√
|
√
|
√
|
√
|
