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Table 1 Schematic diagram of part A

From: Efficacy and safety of Qing-Feng-Gan-Ke Granules in patients with postinfectious cough: study protocol of a novel-design phase III placebo-controlled, double-blind randomized trial

Phase Supervision period
Time-point Baseline Visit 1 Visit 2 Visit 3
Day 0 8 ± 1 15 ± 2 Follow-up
Basic history collection ×    
 Informed consent ×    
 Demographics ×    
 Enrollment based on the inclusion/exclusion criteria ×    
 Coexisting diseases or symptoms ×    
 Concomitant treatments   × ×  
Efficacy evaluation     
 Cough symptom score × × × ×
 TCM syndrome score × × ×  
Safety evaluation     
 Vital signs × × ×  
 Blood routine and urine routine ×   ×  
 Liver function (ALT, AST, STB, ALP, γ-GT ) ×   ×  
 Renal function (Cr, BUN) ×   ×  
 ECG ×   ×  
 Adverse events   × ×  
Screening tests     
 CR ×    
 BPT ×    
 UPT (women of childbearing age) ×    
Other steps     
 Randomization allocation ×    
 Drug distribution ×    
Remaining drug count    ×  
Patient record card distribution/recycling ×   ×