DaZhu Rhodiola Rosea Capsule for Coronary Artery Disease With Angina Pectoris

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: DaZhu Rhodiola Rosea Capsule; Drug: DaZhu Rhodiola Rosea Simulation Capsule

• Study Type: Interventional
• Enrollment (Anticipated): 102
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100029
    • Beijing Anzhen Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DaZhu Rhodiola Rosea Capsule	Drug: DaZhu Rhodiola Rosea Capsule; Oral administration, 4 capsules, 3 times a day, for 8 weeks
PLACEBO_COMPARATOR: DaZhu Rhodiola Rosea Simulation Capsule	Drug: DaZhu Rhodiola Rosea Simulation Capsule; Oral administration, 4 capsules, 3 times a day, for 8 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Collaborators: Jiangsu Kangyuan Pharmaceutical Co. Ltd

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2018
• Primary Completion (ANTICIPATED): February 1, 2019
• Study Completion (ANTICIPATED): February 1, 2019

Study Registration Dates

• First Submitted: August 7, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (ACTUAL): August 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2018
• Last Update Submitted That Met QC Criteria: August 14, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Angina Pectoris
• Other Study ID Numbers: 2017032

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No