DaZhu Rhodiola Rosea Capsule for Coronary Artery Disease With Angina Pectoris

NCT ID: NCT03633890

Last Updated: 2018-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-31

Study Completion Date

2019-02-28

Brief Summary

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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

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DaZhu Rhodiola Rosea Capsule

Group Type EXPERIMENTAL

DaZhu Rhodiola Rosea Capsule

Intervention Type DRUG

Oral administration, 4 capsules, 3 times a day, for 8 weeks

DaZhu Rhodiola Rosea Simulation Capsule

Group Type PLACEBO_COMPARATOR

DaZhu Rhodiola Rosea Simulation Capsule

Intervention Type DRUG

Oral administration, 4 capsules, 3 times a day, for 8 weeks

Interventions

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DaZhu Rhodiola Rosea Capsule

Oral administration, 4 capsules, 3 times a day, for 8 weeks

Intervention Type DRUG

DaZhu Rhodiola Rosea Simulation Capsule

Oral administration, 4 capsules, 3 times a day, for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu Kangyuan Pharmaceutical Co. Ltd

UNKNOWN

Sponsor Role collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shao-Ping Nie

Professor of Medicine, Director, Emergency & Critical Care Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Anzhen Hospital, Capital Medical University

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Shao-Ping Nie, MD, PhD

Role: CONTACT

86-10-84005256

Xiao Wang, MD

Role: CONTACT

86-10-84005255

Facility Contacts

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Shao-Ping Nie, MD, PhD

Role: primary

86-10-84005256

Other Identifiers

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2017032

Identifier Type: -

Identifier Source: org_study_id

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