This is a double-blind, randomized placebo-controlled trial which aims to evaluate the efficacy and safety of Wen Xin granule in patients with unstable angina pectoris.
Coronary heart disease has remained the leading cause of death worldwide over the past decades. Unstable angina is a clinical syndrome intermediate in severity between stable angina and acute myocardial infarction with high morbidity and mortality. Standard drug therapy and invasive revascularization are effective in decreasing progression to infarction, reducing symptoms and multiple hospitalizations, in most cases without a decrease in the long-term mortality rate. However, there are still many patients with persistence or recurrence of angina despite standard medical therapy and/or revascularization. Wen Xin granule, as a Chinese herbal medicine has shown great effect in patients with unstable angina in our clinical. However, there is still insufficient evidence on his specific efficacy and safety. Therefor, we'd like to evaluate the efficacy and safety of Wen Xin granule in patients with unstable angina through this multi-center, double-blind, randomized placebo-controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
502
one dose daily, two times per day.
one tablet daily. (for patients who can't use aspirin)
20 mg tablet, one tablet each night.
Major adverse cardiovascular events
Including recurrent angina, acute myocardial infarction, severe arrhythmia, heart failure, and cardiac death.
Time frame: Record the incidence of major adverse cardiovascular events in one year by follow-up.
The thrombelastograph
Parameters assessed by were R (represent clotting time), K and Angle (reflect clot strength and development), MA (maximum platelet-fibrin clot strength), CI (represents overall coagulability), and LY30 (represents lysis).
Time frame: Before treatment and at eight weeks after treatment.
TCM symptom scale score
TCM syndrome scale includes items of chest tightness, chest pain, heavy body, obesity, phlegm, dark complexion, tongue condition and pulse condition. The chest tightness and chest pain, have 4-grade options of none, mild, moderate and severe, marked as 0, 2, 4 and 6 respectively. The other items have two options of yes or no, marked as 0 and 1 respectively. The higher scores mean more serious symptoms.
Time frame: Before treatment, four and eight weeks after treatment.
Seattle angina questionnaire
The SAQ regroups 19 items measuring five specific scales: physical limitations, anginal stability, anginal frequency, treatment satisfaction and disease perception targeting a specific disease and treatment group. Higher scores mean a better outcome.
Time frame: Before treatment, four and eight weeks after treatment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
one tablet, twice daily.
12.5 mg or 25 mg, two times daily.
100mg tablet, one tablet daily.
one dose daily, two times per day.
20 mg tablet, one tablet three times daily.
be taken when angina pectoris attacks.