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 |