Efficacy and safety of Naoxintong capsule for treating chronic stable angina: study protocol for a randomized controlled trial

Table 2 Measurement items and points of data capture

Study phase	Run-in period		Intervention period
Time	Visit 1	Visit 2	Visit3	Visit4	Visit5
	−14 ± 2 days	−4 ~ 0 days	4 weeks ± 4 days	8 weeks ± 4 days	12 weeks ± 4 days
Baseline data collection
Informed consent	×
Demographic data	×
Concomitant disease and treatment	×	×	×	×	×
Inclusion/exclusion criteria		×
Screen index
Urinary pregnancy test	×
Safety evaluation
Vital signs	×	×	×	×	×
Blood and urine routine, stool routine + occult blood, fasting blood glucose		×			×
Liver function (ALT, AST, TBIL) and renal function test (BUN, Cr)		×			×
Coagulation function test		×			×
Blood lipid level		×			×
ECG	×	×			×
Efficiency evaluation
TCM syndrome score	×	×			×
Scores of angina symptoms	×	×	×	×	×
CCS angina classification	×	×	×	×	×
Number of episodes of AP per week	×	×	×	×	×
Nitroglycerin consumption	×	×	×	×	×
Score of seattle angina scale	×	×	×	×	×
Homocysteine		×			×
Other work					×
Random grouping		×
Dispense drug	×	×	×	×
Recovery drug		×	×	×	×
Aes records		×	×	×	×
Evaluate the clinical efficacy and adherence					×

ISSN: 1745-6215