DaZhu Rhodiola Rosea Capsule for Coronary Artery Disease With Angina Pectoris

Coronary Artery Disease Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Trial for DaZhu Rhodiola Rosea Capsule in the Treatment of Coronary Artery Disease With Angina Pectoris

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03633890
• Other study ID #: 2017032
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 2018
• Est. completion date: February 2019

Study information

• Verified date: August 2018
• Source: Beijing Anzhen Hospital
• Contact: Shao-Ping Nie, MD, PhD
• Phone: 86-10-84005256
• Email: spnie[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 18 to 75 years old

• Coronary heart disease with grade ? or ? 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 ?, ? or left ventricular ejection fraction (LVEF) < 40%), severe arrhythmia (rapid atrial fibrillation and flutter, paroxysmal ventricular tachycardia, degree ? type ? and degree ? 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

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• DaZhu Rhodiola Rosea Capsule
Oral administration, 4 capsules, 3 times a day, for 8 weeks
• DaZhu Rhodiola Rosea Simulation Capsule
Oral administration, 4 capsules, 3 times a day, for 8 weeks

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital	Jiangsu Kangyuan Pharmaceutical Co. Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seattle Angina Questionnaire (SAQ) angina frequency	Scored from 0 to 100, with higher scores indicating better health status	week 8
Secondary	SAQ angina stability	Scored from 0 to 100, with higher scores indicating better health status	week 8
Secondary	SAQ physical limitation	Scored from 0 to 100, with higher scores indicating better health status	week 8
Secondary	SAQ treatment satisfaction	Scored from 0 to 100, with higher scores indicating better health status	week 8
Secondary	SAQ disease perception	Scored from 0 to 100, with higher scores indicating better health status	week 8
Secondary	Walking distance by 6-minute walking test		week 8
Secondary	Frequency of angina		week 8
Secondary	visual analogue scale (VAS) score	Scored from 0 to 10, with higher scores indicating worse health status	week 8
Secondary	36-item Short Form Health Survey (SF-36) score	Scored from 36 to 180, with higher scores indicating better health status	week 8