Research Article
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 | | × | × | × | × | × | |
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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.
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