|
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
|
×
| |
×
| |
