Clinical trial NCT03633890: DaZhu Rhodiola Rosea Capsule for Coronary Artery Disease With Angina Pectoris
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial for DaZhu Rhodiola Rosea Capsule in the Treatment of Coronary Artery Disease With Angina Pectoris
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
Collaborators: name: Jiangsu Kangyuan Pharmaceutical Co. Ltd
First posted: 2018-08-16
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy and safety of traditional Chinese medicine DaZhu Rhodiola Rosea Capsule for treatment of coronary artery disease by observing angina symptoms, exercise capacity, and quality of life.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 75 years old
* Coronary heart disease with grade Ⅱ or Ⅲ stable or unstable angina (≥ 2 times per week), or residual angina-like symptoms 1 month to 1 year post percutaneous coronary intervention (PCI) or 3 months to 1 year post coronary artery bypass surgery (CABG)
* Written informed consent

Exclusion Criteria:

* Acute myocardial infarction within 1 month before admission
* Patients who plan to undergo revascularization in the next 3 months
* Congestive heart failure, acute myocarditis or pericarditis, thrombophlebitis, pulmonary embolism, or severe neurosis within 3 months prior to admission
* Patients with uncontrolled high blood pressure (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg), severe cardiopulmonary insufficiency (cardiac function grade Ⅲ, Ⅳ or left ventricular ejection fraction (LVEF) \< 40%), severe arrhythmia (rapid atrial fibrillation and flutter, paroxysmal ventricular tachycardia, degree Ⅱ type Ⅱ and degree Ⅲ atrioventricular block, etc.)
* Severe liver, kidney and hematopoietic system dysfunction or psychosis (serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 times the normal upper limit, or serum creatinine \> 1.5 times the normal upper limit)
* History of bleeding or treatment with warfarin
* Implanted pacemakers
* Pregnant or lactating women
* Allergic to study drugs
* Legal disability (blindness, deafness, dumbness, intellectual disability, mental disability, physical disability)
* Patients who participated in other clinical trials within 3 months

Primary outcomes:
measure: Seattle Angina Questionnaire (SAQ) angina frequency
timeFrame: week 8
Secondary outcomes:
measure: SAQ angina stability
timeFrame: week 8
measure: SAQ physical limitation
timeFrame: week 8
measure: SAQ treatment satisfaction
timeFrame: week 8
measure: SAQ disease perception
timeFrame: week 8
measure: Walking distance by 6-minute walking test
timeFrame: week 8
measure: Frequency of angina
timeFrame: week 8
measure: visual analogue scale (VAS) score
timeFrame: week 8
measure: 36-item Short Form Health Survey (SF-36) score
timeFrame: week 8
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
Study officials:
References: