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 | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Record of medical history | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Demographic information | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
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 | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | X |
HbA1c | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | X |
serum TC, LDL-C, VLDL-C | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | X |
Blood and urine regulation | X | Â | Â | Â | Â | Â | X | Â | Â | Â | Â | Â | X |
ALT, AST | X | Â | Â | X | Â | Â | X | Â | Â | X | Â | Â | X |
BUN, Cr | X | Â | Â | X | Â | Â | X | Â | Â | X | Â | Â | X |
Electrocardiogram | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Pregnancy Test | X | Â | Â | Â | Â | Â | X | Â | Â | Â | Â | Â | X |
Selection/exclusion criteria | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Drugs of prohibition | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
SF-36 | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | X |
Evaluation of TCM Syndrome | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | X |
Obtain random code | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Dial 800 to Assign drug | X | Â | Â | X | Â | Â | X | Â | Â | X | Â | Â | Â |
Drug Distribution and record | X | X | X | X | X | X | X | X | X | X | X | X | Â |
End-point events | Â | 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 | Â | X | X | X | X | X | X | X | X | X | X | X | X |