Table 2 Schematic diagram of part B

Basic history collection

×

 Informed consent

×

 Demographics

×

 Enrollment based on the inclusion/exclusion criteria

×

 Coexisting diseases or symptoms

×

 Concomitant treatments

×

×

Efficacy evaluation

 Cough symptom score

×

×

×

×

 Cough VAS score

×

×

×

 TCM syndrome score

×

×

×

 CQLQ

×

×

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

×

×