DaZhu Rhodiola Rosea Capsule for Coronary Artery Disease With Angina Pectoris

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Drug: DaZhu Rhodiola Rosea Simulation Capsule; Drug: DaZhu Rhodiola Rosea Capsule

• Registration Number: NCT03633890
• Lead Sponsor: Beijing Anzhen Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-08
• Study Start: 2018-08
• Study First Submitted: 2018-08-07
• Study First Submitted QC: 2018-08-14
• Last Update Submitted: 2018-08-14
• Study First Posted: 2018-08-16
• Last Update Posted: 2018-08-16
• Primary Completion: 2019-02
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DaZhu Rhodiola Rosea Simulation Capsule	DaZhu Rhodiola Rosea Simulation Capsule	-
DaZhu Rhodiola Rosea Capsule	DaZhu Rhodiola Rosea Capsule	-

Primary Outcome Measures

Name	Time	Method
Seattle Angina Questionnaire (SAQ) angina frequency	week 8	Scored from 0 to 100, with higher scores indicating better health status

Secondary Outcome Measures

Name	Time	Method
SAQ angina stability	week 8	Scored from 0 to 100, with higher scores indicating better health status
visual analogue scale (VAS) score	week 8	Scored from 0 to 10, with higher scores indicating worse health status
36-item Short Form Health Survey (SF-36) score	week 8	Scored from 36 to 180, with higher scores indicating better health status
SAQ physical limitation	week 8	Scored from 0 to 100, with higher scores indicating better health status
SAQ treatment satisfaction	week 8	Scored from 0 to 100, with higher scores indicating better health status
SAQ disease perception	week 8	Scored from 0 to 100, with higher scores indicating better health status
Walking distance by 6-minute walking test	week 8
Frequency of angina	week 8

Trial Locations

Locations (1)

Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, China