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DaZhu Rhodiola Rosea Capsule for Coronary Artery Disease With Angina Pectoris

Sponsor
Beijing Anzhen Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03633890
Collaborator
Jiangsu Kangyuan Pharmaceutical Co. Ltd (Other)
102
Enrollment
1
Location
2
Arms
6
Anticipated Duration (Months)
16.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: DaZhu Rhodiola Rosea Capsule
  • Drug: DaZhu Rhodiola Rosea Simulation Capsule
 Phase 4

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Aug 1, 2018
Anticipated Primary Completion Date :
Feb 1, 2019
Anticipated Study Completion Date :
Feb 1, 2019

Arms and Interventions

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

Primary Outcome Measures

  1. Seattle Angina Questionnaire (SAQ) angina frequency [week 8]

    Scored from 0 to 100, with higher scores indicating better health status

Secondary Outcome Measures

  1. SAQ angina stability [week 8]

    Scored from 0 to 100, with higher scores indicating better health status

  2. SAQ physical limitation [week 8]

    Scored from 0 to 100, with higher scores indicating better health status

  3. SAQ treatment satisfaction [week 8]

    Scored from 0 to 100, with higher scores indicating better health status

  4. SAQ disease perception [week 8]

    Scored from 0 to 100, with higher scores indicating better health status

  5. Walking distance by 6-minute walking test [week 8]

  6. Frequency of angina [week 8]

  7. visual analogue scale (VAS) score [week 8]

    Scored from 0 to 10, with higher scores indicating worse health status

  8. 36-item Short Form Health Survey (SF-36) score [week 8]

    Scored from 36 to 180, with higher scores indicating better health status

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Beijing Anzhen Hospital, Capital Medical University Beijing China 100029

Sponsors and Collaborators

  • Beijing Anzhen Hospital
  • Jiangsu Kangyuan Pharmaceutical Co. Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Aug 16, 2018
Last Update Posted:
Aug 16, 2018
Last Verified:
Aug 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina Pectoris

Study Results

No Results Posted as of Aug 16, 2018