Chinese Herbal Formula Xuefu Zhuyu for Stable Angina (CheruSA): Study Protocol for a Multicenter Randomized Controlled Trial

Table 1

Content for the schedule of enrolment, interventions, and assessments.

Study phase	Run-in period	Treatment period					Follow-up period
Time	Visit 1	Baseline	Visit 1	Visit 2	Visit 3	Visit 4	Visit 5
	Week 2	Week 0	Week 2	Week 4	Week 8	Week 12	Week 24
Patient
Inclusion/exclusion criteria	×
Informed consent	×
Random grouping	×
Demographic data	×	×
Allergic history	×
Personal history	×
Previous history	×
Family history of cardiovascular disease	×
Drug treatment for SA within the past three months	×
Interventions
Experimental group		×	×	×	×	×
Control group		×	×	×	×	×
Outcomes measurements
Average angina pain intensity (VAS)	×	×	×	×	×	×	×
Angina attack frequency	×	×	×	×	×	×	×
Angina attack duration		×	×	×	×	×	×
Nitroglycerin dosage		×	×	×	×	×	×
CCS grading of effort angina	×	×	×	×	×	×	×
Change of CM pattern		×	×	×	×	×	×
SAQ		×		×	×	×	×
EQ-5d-5 L		×	×	×	×	×	×
MACEs
Health cost evaluation		×	×	×	×	×
Overall drug assessment						×
Safety assessment
Vital signs	×	×	×	×	×	×	×
Routine blood and urine analysis, liver and renal function tests, coagulation function test, ECG and UCG		×				×
Adverse events
Other work
Concomitant medications
Compliance measurement		×	×	×	×	×

SA: stable angina, VSA: visual analogue scale, CCS : Canadian Cardiovascular Society, CM : Chinese medicine, SAQ : Seattle Angina Questionnaire, EQ-5D-5 L : EuroQol-5-Dimensions-5-Level, MACEs: major adverse cardiac events, ECG : Electrocardiogram.