Table 1 Content of data capture(to be continued)
From: JinQi-Jiangtang tablet, a Chinese patent medicine, for pre-diabetes: a randomized controlled trial
| Item | Screening period (unit: month) | Intervention period (unit: month) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| -0.5 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | |
| ICF | X | ||||||||||||
| Record of medical history | X | ||||||||||||
| Demographic information | X | ||||||||||||
| General physical examination | X | X | X | X | X | X | X | X | X | X | X | X | X |
| FBG | X | X | X | X | X | X | X | X | X | X | X | X | X |
| PBG | X | X | X | X | X | X | X | X | X | X | X | X | X |
| OGTT | X | X | X | X | X | X | X | X | X | X | X | X | X |
| Insulin release test | X | X | |||||||||||
| HbA1c | X | X | |||||||||||
| serum TC, LDL-C, VLDL-C | X | X | |||||||||||
| Blood and urine regulation | X | X | X | ||||||||||
| ALT, AST | X | X | X | X | X | ||||||||
| BUN, Cr | X | X | X | X | X | ||||||||
| Electrocardiogram | X | ||||||||||||
| Pregnancy Test | X | X | X | ||||||||||
| Selection/exclusion criteria | X | ||||||||||||
| Drugs of prohibition | X | ||||||||||||
| SF-36 | X | X | |||||||||||
| Evaluation of TCM Syndrome | X | X | |||||||||||
| Obtain random code | X | ||||||||||||
| Dial 800 to Assign drug | X | X | X | X | |||||||||
| Drug Distribution and record | X | X | X | X | X | X | X | X | X | X | X | X | |
| End-point events | X | X | X | X | X | X | X | X | X | X | X | X | |
| Adverse events | X | X | X | X | X | X | X | X | X | X | X | X | X |
| Drug combination | X | X | X | X | X | X | X | X | X | X | X | X | |