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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.