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Table 3 Research flowchart

From: Huatan Dingji Decoction intervening in atrial fibrillation: protocol for a randomized double-blind single-simulated placebo-controlled clinical trial

Activity

Phase(time points)

Screening stage

baseline period

intervention

Follow-up

  

−3d~0d

0d

4w

8w

12w

Enrolment

Sign informed consent

    

Inclusion and exclusion criteria

    

Demographic data

    

Medical history and treatment history

    

Basic data collection

    

Outcome assessment

Frequency of atrial fibrillation

 

ECG and Holter

 

Ultrasonic cardiogram

 

TCM clinical syndrome integral

 

Rate of increase and decrease of anti-arrhythmia western medicine

 

NT-proBNP

 

  

Hamilton Anxiety Scale

 

Hamilton Depression Scale

 

SF-36

 

PVO

 

Anaerobic threshold

 

Safety assessment

Physical examination

 

Blood routine examination

 

  

Urine routine and urinary sediment

 

  

Liver function

 

  

Renal function

 

  

Blood lipid

 

  

GLU

 

  

INR

 

  

CHA2DS2-VAS

 

  

HAS-BCED

 

  

Other information

Randomization

    

Hemorrhage

 

Readmission