Study schedule
Study period | ||||
Time points | Screening period | Treatment phase | ||
Baseline | 1st day | 5th day | 10th day | |
Enrolment | ||||
General condition | √ | |||
Clinical symptoms | √ | |||
Medical history | √ | |||
Fulfilling inclusion and exclusion criteria | √ | |||
Sign informed consent | √ | |||
Assessment | ||||
Primary outcome | ||||
Saturation of peripheral oxygen (SpO2) | √ | √ | √ | √ |
Respiratory rate (RR) | √ | √ | √ | √ |
Secondary outcomes | ||||
The TCM syndrome score | √ | √ | ||
Infection-related index | √ | √ | ||
Ventilator-related indicators | √ | √ | ||
Blood gas analysis-related indicators | √ | √ | ||
Record of adverse events | √ | √ | √ | |
Compliance evaluation | √ | |||
Safety assessment | √ |
TCM, traditional Chinese medicine.