Evidence-Based Complementary and Alternative Medicine / 2018 / Article / Tab 1 / Research Article
Efficacy and Safety of Zhenyuan Capsule for Coronary Heart Disease with Abnormal Glucose and Lipid Metabolism: Study Protocol for a Randomized, Double-Blind, Parallel-Controlled, Multicenter Clinical Trial Table 1 Measurement items and time points for data collection.
Screening Treatment period T0 Run-in period Week 4 Week 8 Week 12 Basic medical history recording Informed consent × Inclusion/exclusion criteria × Demographic data × Medical and treatment history recording × Complication and symptom recording × Concomitant medication × × × × Vital signs × × × × Efficacy observation TG, FBG, 2hPBG, and HbA1c levels × × × × × TCM symptom indicators × × × × Seattle Angina Questionnaire score × × × × Coagulation indicator × × × × P-selectin level × × × × Angina pectoris scores and end-point event × × × × ECG × × UCG × × Safety assessment Liver and renal function tests × × × × × Hemorrhage × × × × Routine blood and urine tests × × Routine stool and occult blood tests × × Other works Randomization and allocation × Drug distribution × × × Medicine recycling and drug quantity statistics × × ×
