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Table 1 Follow-up chart of treatment using ban-lan-gen granules against seasonal influenza

From: Efficacy and safety of Ban-Lan-Gen granules in the treatment of seasonal influenza: study protocol for a randomized controlled trial

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

  1. X, must implement; a, necessary to implement.