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Table 2 Study schedule of clinical trial (6 months)

From: Effects of Qishe Pill, a compound traditional Chinese herbal medicine, on cervical radiculopathy: study protocol for a randomized controlled trial

 

Initial screening

Treatment times

Follow-up

 

Visit 1

Visit 2

Visit 3

Visit 4

Visit 5

Visit 6

 

Week 0

Week 1

Week 2

Week 4

Month 2

Month 5

Determined the exclusion criteria

Yes

     

Informed consent

Yes

     

Randomized

Yes

     

Weight

Yes

 

Yes

Yes

  

Blood pressure

Yes

 

Yes

Yes

  

Heart rate/Rhythm

Yes

 

Yes

Yes

  

Respiratory rate

Yes

 

Yes

Yes

  

Spurling’s test

Yes

     

Brachial plexus force test

Yes

     

Drug allergy history

Yes

     

Blood routine

Yes

  

Yes

  

Urine routine

Yes

  

Yes

  

Excrement routine

Yes

  

Yes

  

Occult blood

Yes

  

Yes

  

ECG

Yes

  

Yes

  

Liver function test

Yes

  

Yes

  

Kidney function test

Yes

  

Yes

  

X-ray (frontal and lateral)

Yes

  

Yes

  

Concomitant medication

 

Yes

Yes

Yes

  

VAS scores

Yes

Yes

Yes

Yes

Yes

Yes

NDI scores

Yes

 

Yes

Yes

Yes

Yes

SF-36 scores

 

Yes

Yes

Yes

  

The medicine issue

 

Yes

Yes

   

Compliance assessment

  

Yes

Yes

  

Degree of satisfaction

   

Yes

  

Safety evaluation

 

Yes

 

Yes

  
  1. ECG: Electrocardiogram; VAS: Visual analogue scale; NDI: Neck disability index: SF-36: The MOS item short from health survey.