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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
  1. X: Item need to be done during different period.
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