Table 3.
Study Period | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Enrollment | Allocation | Intervention | Follow-up | ||||||||
Time point (weeks) | −2 | 0 | 4 | 8 | 12 | 16 | 20 | 24 | 28 | 36 | 48 |
Eligibility screen | √ | ||||||||||
Written informed consent | √ | ||||||||||
Medical history | √ | ||||||||||
Physical examination | √ | √ | √ | √ | √ | √ | √ | ||||
Routine blood and urine | √ | √ | √ | √ | |||||||
Electrocardiogram | √ | √ | √ | √ | |||||||
ALT, AST, ALP, GGT, TBIL | √ | √ | √ | √ | |||||||
24 h urinary protein | √ | √ | √ | √ | √ | √ | √ | √ | |||
Serum Cr, eGFR | √ | √ | √ | √ | √ | √ | √ | √ | |||
TC, TG, LDL-C, HDL-C | √ | √ | √ | √ | √ | ||||||
A1C, CRP | √ | √ | √ | √ | |||||||
Evaluation of TCM syndrome | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | |
Drug distribution | √ | √ | √ | √ | √ | √ | |||||
Retrieval of unused drugs | √ | √ | √ | √ | √ | √ | |||||
Adverse events | √ | √ | √ | √ | √ | √ | √ | √ | √ |
Abbreviations: A1C hemoglobin A1C, ALP alkaline phosphatase, ALT alanine transaminase, AST aspartate aminotransferase, eGFR estimated glomerular filtration rate, GGT gamma-glutamyl transpeptidase, LDL-C low-density lipoprotein cholesterol, serum Cr serum creatinine, TBIL total bilirubin, TC total cholesterol, TCM traditional Chinese medicine, TG triglycerides, HDL-C high-density lipoprotein cholesterol
√ = Action items