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

Table 1 Measurement items and points of data capture

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						×

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

ISSN: 1745-6215