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Table 1 Measurement items and point of data capture

From: The key role of Shenyan Kangfu tablets, a Chinese patent medicine for diabetic nephropathy: study protocol for a randomized, double-blind and placebo-controlled clinical trial

 

Screening

Baseline

Treatment

 

Visit 1

Visit 2

Visit 3

Visit 4

Visit 5

Visit 6

Visit 7

Items

−2 weeks

0 weeks

2 weeks

4 weeks

8 weeks

12 weeks

16 weeks

Informed consent form

X

      

Inclusion/exclusion criteria

X

      

Demographic information

X

      

Medical/drug use history

X

      

Concomitant disease and treatment

X

      

General physical examination

X

      

Combined medication

X

X

X

X

X

X

X

Vital signs

X

X

X

X

X

X

X

TCM symptom

X

X

X

X

X

X

X

Urine protein test

X

X

X

X

X

X

X

Routine urine test

X

X

X

X

X

X

X

Renal function (SCR, BUN, GFR) Serum albumin

X

X

X

   

X

Routine blood test

X

X

    

X

Stool routine test and fecal occult blood test

X

X

    

X

Liver function (ALT/AST/GGT/TBIL/ALB)

X

X

    

X

Blood electrolytes

X

X

X

   

X

Blood coagulation (TT/APTT/PT/FIB)

X

X

    

X

Blood glucose

X

X

X

X

X

X

X

Glycosylated hemoglobin

X

X

  

X

  

Electrocardiogram (EGG)

X

X

    

X

Adverse events

X

X

X

X

X

X

X

Randomization

 

X

     

Drug distribution

X

X

X

X

X

X

 

Drug recycling

 

X

X

X

X

X

X

Drug count

 

X

X

X

X

X

X

Research conclusion

      

X

  1. X: Have indicators tested in the specific time period. ALB, serum albumin; ALT, alanine aminotransferase; APTT, activated partial thromboplastin time; AST, aspartate aminotransferase; BUN, blood urea nitrogen; FIB, fibrinogen; GFR, glomerular filtration rate; GGT, gamma-glutamyl transpeptidase; PT, prothrombin time; SCR, serum creatinine; TBIL, total bilirubin; TCM, traditional Chinese medicine; TT, thrombin time.
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Trials

ISSN: 1745-6215