Table 1 Content of data capture
Research stage | Baseline | Treatment period | ||
|---|---|---|---|---|
Item | 0 | 4 weeks ± 3 days | 8 weeks ± 3 days | 12 weeks ± 3 days |
Visiting no. | V1 | V2 | V3 | V4 |
Demographic data/baseline | ||||
 Inclusion/exclusion criteria | √ |  |  |  |
 Informed consent | √ |  |  |  |
 History of disease and treatment | √ |  |  |  |
 Physical examination | √ | √ | √ | √ |
 Complications and concomitant medications | √ |  |  |  |
Outcome assessments | ||||
 Lipid profiles | √ | √ | √ | √ |
 Hs-CRP | √ | √ | √ | √ |
 Blood pressure | √ | √ | √ | √ |
 Body weight | √ | √ | √ | √ |
 Bristol Stool Chart | √ | √ | √ | √ |
 TCM symptom form | √ | √ | √ | √ |
 Adipokine profiles | √ |  |  | √ |
 Intestinal microbiota | √ |  |  | √ |
Safety assessment | ||||
 Blood routine measurements | √ |  |  | √ |
 Urine routine measurements | √ |  |  | √ |
 Liver function (ALT, AST) | √ |  |  | √ |
 Kidney function (BUN, Cr) | √ |  |  | √ |
 Adverse events | √ | √ | √ | √ |
Others | ||||
 Randomization | √ |  |  |  |
 Drug distribution | √ | √ | √ |  |
 Drug recycling and counting |  | √ | √ | √ |
 Record concomitant medications |  | √ | √ | √ |
 Study conclusion |  |  |  | √ |