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Table 1 Measurement items and points of data capture

From: Guanxinjing capsule in the treatment of chronic stable angina: study protocol for a randomized controlled trial

Study phase Run-in period Intervention period
  Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6
Time -14 days 0 day 2 weeks 4 weeks 6 weeks 8 weeks
Baseline data collection
 Informed consent ×      
 Inclusion/exclusion criteria ×      
 Demographic data ×      
 Get the central random number ×      
 Concomitant disease and treatment ×      
 Previous history、medical history and allergies ×      
Safety evaluation
 Vital signs × × × × × ×
 Complete blood count, urine and stool tests   ×     ×
 Liver and renal function tests   ×     ×
 Coagulation function test   ×     ×
 Cardiovascular events × × × × × ×
 Adverse event evaluation × × × × × ×
Efficiency evaluation
 Exercise treadmill testing’   ×   ×   ×
 TCM syndrome score × × × × × ×
 GAD-7 score × × × × × ×
 CCS angina classification × × × × × ×
 SF-36 score × × × × × ×
 Nitroglycerin consumption × × × × × ×
Other work
 Concomitant medications × × × × × ×
 Dispense drug × × × × ×  
 Recovery and record of study drug   × × × × ×
 Evaluate the adherence   × × × × ×
 Study completion status    × × × ×
 CRF examination       ×
  1. Abbreviations: SF36 36-item Short Form Health Survey, TCM traditional Chinese medicine, CCS Canadian Cardiovascular Society, GAD-7 Generalised Anxiety Disorder Assessment , CRF Case Report Form