Table 1.
Follow-up chart of treatment using ban-lan-gen granules against seasonal influenza
| Visit cycle evaluation projects | Screening stage | Remedial period | |||
|---|---|---|---|---|---|
| Visit 0 day 0.5 to 0 | Visit 1 Day 3 + 1 after administration | Visit 2 Day 5 + 1 after administration | Visit 3 Day 7 + 1 after administration | Visit 4 Day 21 + 7 after administration | |
| Acquisition of basic medical history | |||||
| Informed consent | X | ||||
| Basic conditions | X | ||||
| Symptoms | X | X | X | X | |
| Inclusion and exclusion criteria | X | ||||
| Safety observations | |||||
| Vital signs | X | X | |||
| Electrocardiography | X | a | a | X | |
| Chest radiograph | X | a | a | a | |
| Laboratory inspection | X | a | a | X | |
| Record adverse events | X | X | X | X | X |
| Efficacy | |||||
| Record influenza symptoms | X | X | X | X | |
| Virology | |||||
| Rapid diagnostic tests | X | ||||
| Real-time PCR analyses | X | X | X | X | |
| Viral isolation culture | X | X | X | X | |
| Viral antibody titer | X | X | |||
| Other | |||||
| Grouping and giving drugs | X | ||||
| Administer drugs | X | X | X | ||
| Distribute patient diary card | X | ||||
| Accompanying treatment | A | A | a | a | |
| Compliance | X | X | X | X | |
| Inspection results | X | X | |||
| Original record completion | X | X | X | X | X |
| Recover study drug | X | ||||
| Recover patient diaries | X | ||||
| CRF review, recovering and test summary | X | ||||
X, must implement; a, necessary to implement.