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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