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DaZhu Rhodiola Rosea Capsule for Coronary Artery Disease With Angina Pectoris

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
DaZhu Rhodiola Rosea Capsule
DaZhu Rhodiola Rosea Simulation Capsule
Sponsored by
Beijing Anzhen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Anzhen Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DaZhu Rhodiola Rosea Capsule

DaZhu Rhodiola Rosea Simulation Capsule

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 7, 2018
Last Updated
August 14, 2018
Sponsor
Beijing Anzhen Hospital
Collaborators
Jiangsu Kangyuan Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03633890
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2018 (Anticipated)
Primary Completion Date
February 2019 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital
Collaborators
Jiangsu Kangyuan Pharmaceutical Co. Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DaZhu Rhodiola Rosea Capsule
Arm Type
Experimental
Arm Title
DaZhu Rhodiola Rosea Simulation Capsule
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DaZhu Rhodiola Rosea Capsule
Intervention Description
Oral administration, 4 capsules, 3 times a day, for 8 weeks
Intervention Type
Drug
Intervention Name(s)
DaZhu Rhodiola Rosea Simulation Capsule
Intervention Description
Oral administration, 4 capsules, 3 times a day, for 8 weeks
Primary Outcome Measure Information:
Title
Seattle Angina Questionnaire (SAQ) angina frequency
Description
Scored from 0 to 100, with higher scores indicating better health status
Time Frame
week 8
Secondary Outcome Measure Information:
Title
SAQ angina stability
Description
Scored from 0 to 100, with higher scores indicating better health status
Time Frame
week 8
Title
SAQ physical limitation
Description
Scored from 0 to 100, with higher scores indicating better health status
Time Frame
week 8
Title
SAQ treatment satisfaction
Description
Scored from 0 to 100, with higher scores indicating better health status
Time Frame
week 8
Title
SAQ disease perception
Description
Scored from 0 to 100, with higher scores indicating better health status
Time Frame
week 8
Title
Walking distance by 6-minute walking test
Time Frame
week 8
Title
Frequency of angina
Time Frame
week 8
Title
visual analogue scale (VAS) score
Description
Scored from 0 to 10, with higher scores indicating worse health status
Time Frame
week 8
Title
36-item Short Form Health Survey (SF-36) score
Description
Scored from 36 to 180, with higher scores indicating better health status
Time Frame
week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shao-Ping Nie, MD, PhD
Phone
86-10-84005256
Email
spnie@ccmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao Wang, MD
Phone
86-10-84005255
Email
spaceeye123@126.com
Facility Information:
Facility Name
Beijing Anzhen Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shao-Ping Nie, MD, PhD
Phone
86-10-84005256
Email
spnie@ccmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Shao-Ping Nie, MD, PhD

12. IPD Sharing Statement

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DaZhu Rhodiola Rosea Capsule for Coronary Artery Disease With Angina Pectoris

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