Skip to main content

Table 2 SPIRIT table: Measurement items and time points of data capture

From: Yinang formulation versus placebo granules as a treatment for chronic kidney disease stages III–IV in patients with autosomal dominant polycystic kidney disease: study protocol for a double-blind placebo-controlled randomized clinical trial

Items

Screening

Baseline

Treatment

Follow-up

Visit 1

Visit 2

Visit 3

Visit 4

Visit 5

Visit 6

Visit 7

Visit 8

Visit 9

−24 weeks

0 weeks

4 weeks

8 weeks

12 weeks

16 weeks

20 weeks

24 weeks

48 weeks

General

Informed consent

×

        

Inclusion and exclusion criteria

×

        

Collect general information

×

        

General physical examination

×

        

Urine hCG (only women)

×

        

Medical and drug use history

×

        

Concomitant disease and treatment

×

        

Combined medication

×

×

×

×

×

×

×

×

×

Effectiveness observation

Vital signs

×

×

×

×

×

×

×

×

×

TCM symptoms

×

×

×

×

×

×

×

×

×

Pain evaluation

×

×

×

×

×

×

×

×

×

Renal function (eGFR, Scr, BUN)

×

×

×

×

×

×

×

×

×

MRI (TKV)

×

×

     

×

 

Blood electrolytes

×

×

  

×

  

×

×

Urine β2-MG, mALB/Cr, RBP

×

×

     

×

×

Safety observation

Blood test #

×

×

  

×

  

×

×

Urine test

×

×

×

×

×

×

×

×

×

Stool routine and occult blood test

×

×

  

×

  

×

×

Liver function (ALT, AST, γ-GT)

×

×

  

×

  

×

×

Electrocardiogram

×

×

     

×

×

Other data

Adverse events

  

×

×

×

×

×

×

 

Allocation

 

×

       

Drug distribution

 

×

×

×

×

×

×

  

Drug recycling

  

×

×

×

×

×

×

 

Drug count

  

×

×

×

×

×

×

 

Research conclusion

       

×

×

  1. Each visit allows a window of 3 days
  2. # The blood test assesses the red blood cell count, white blood cell count, hemoglobin level, and platelet level
  3. eGFR estimated glomerular filtration rate, hCG human chorionic gonadotrophin, Scr serum creatinine, BUN blood urea nitrogen, β2-MG β2-microglobulin, mALB/Cr microalbumin/creatinine, MRI magnetic resonance imaging, RBP retinol-binding protein, ALT alanine aminotransaminase, AST aspartate aminotransaminase, γ-GT gamma glutamyl transpeptidase, TCM traditional Chinese medicine, TKV total kidney volume