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DaZhu Rhodiola Rosea Capsule for Coronary Artery Disease With Angina Pectoris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03633890
Recruitment Status : Unknown
Verified August 2018 by Shao-Ping Nie, Beijing Anzhen Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 16, 2018
Last Update Posted : August 16, 2018
Sponsor:
Collaborator:
Jiangsu Kangyuan Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Shao-Ping Nie, Beijing Anzhen Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: DaZhu Rhodiola Rosea Capsule Drug: DaZhu Rhodiola Rosea Simulation Capsule Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial for DaZhu Rhodiola Rosea Capsule in the Treatment of Coronary Artery Disease With Angina Pectoris
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Seattle Angina Questionnaire (SAQ) angina frequency [ Time Frame: week 8 ]
    Scored from 0 to 100, with higher scores indicating better health status


Secondary Outcome Measures :
  1. SAQ angina stability [ Time Frame: week 8 ]
    Scored from 0 to 100, with higher scores indicating better health status

  2. SAQ physical limitation [ Time Frame: week 8 ]
    Scored from 0 to 100, with higher scores indicating better health status

  3. SAQ treatment satisfaction [ Time Frame: week 8 ]
    Scored from 0 to 100, with higher scores indicating better health status

  4. SAQ disease perception [ Time Frame: week 8 ]
    Scored from 0 to 100, with higher scores indicating better health status

  5. Walking distance by 6-minute walking test [ Time Frame: week 8 ]
  6. Frequency of angina [ Time Frame: week 8 ]
  7. visual analogue scale (VAS) score [ Time Frame: week 8 ]
    Scored from 0 to 10, with higher scores indicating worse health status

  8. 36-item Short Form Health Survey (SF-36) score [ Time Frame: week 8 ]
    Scored from 36 to 180, with higher scores indicating better health status


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633890


Contacts
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Contact: Shao-Ping Nie, MD, PhD 86-10-84005256 spnie@ccmu.edu.cn
Contact: Xiao Wang, MD 86-10-84005255 spaceeye123@126.com

Locations
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China
Beijing Anzhen Hospital, Capital Medical University
Beijing, China, 100029
Contact: Shao-Ping Nie, MD, PhD    86-10-84005256    spnie@ccmu.edu.cn   
Principal Investigator: Shao-Ping Nie, MD, PhD         
Sponsors and Collaborators
Beijing Anzhen Hospital
Jiangsu Kangyuan Pharmaceutical Co. Ltd
More Information
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Responsible Party: Shao-Ping Nie, Professor of Medicine, Director, Emergency & Critical Care Center, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT03633890    
Other Study ID Numbers: 2017032
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina Pectoris
Heart Diseases
Cardiovascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations