Evaluation of efficacy and safety of Qiangzhu-qinggan formula as an adjunctive therapy in adult patients with severe influenza: study protocol for a randomized parallel placebo-controlled double-blind multicenter trial

Table 2 shows the timeline of participant assessments/interventions

Process	Screening stage	Intervention stage	Observation stage
Process	Day 0	Day 1 to day 7	Day 14 ± 1	Day 21 ± 2	Day 28 ± 2
Acquisition of basic medical history
▪ Symptoms and signs	x
▪ Basic conditions	x
▪ Informed consent	x
▪ Inclusion and exclusion criteria	x
Efficacy and safety assessment
▪ Vital signs (heart rate, blood pressure, breathing rate and oxygen saturation)	x	x	x	x	x
▪ Electrocardiograph	x	a			x
▪ Chest radiograph	x	a			x
▪ Laboratory inspection	x	a			x
▪ Record adverse events	x	x	x	x	x
▪ Body temperature	x	x (Measured at 4, 8, 12, 16, 20 and 24 o'clock)	x	x	x
▪ Record influenza symptoms	x	x	x	x	x
▪ Use of antibiotics		x	x	x	x
Interventions
▪ QZQG formula or placebo		x
▪ Concomitant medications (record only)	x	x	x	x	x
Other
▪ Distribute patient information diary card	✓
▪ Compliance record		✓
▪ Inspection results record	✓	✓	✓	✓	✓
▪ Complete original record in CRF					✓
▪ CRF reviews and data entry					✓

ISSN: 1745-6215