NCT03633890

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P25-P50 for phase_4 coronary-artery-disease

Timeline
Completed

Started Aug 2018

Shorter than P25 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

August 16, 2018

Status Verified

August 1, 2018

Enrollment Period

6 months

First QC Date

August 7, 2018

Last Update Submit

August 14, 2018

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Seattle Angina Questionnaire (SAQ) angina frequency

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

    week 8

Secondary Outcomes (8)

  • SAQ angina stability

    week 8

  • SAQ physical limitation

    week 8

  • SAQ treatment satisfaction

    week 8

  • SAQ disease perception

    week 8

  • Walking distance by 6-minute walking test

    week 8

  • +3 more secondary outcomes

Study Arms (2)

DaZhu Rhodiola Rosea Capsule

EXPERIMENTAL
Drug: DaZhu Rhodiola Rosea Capsule

DaZhu Rhodiola Rosea Simulation Capsule

PLACEBO COMPARATOR
Drug: DaZhu Rhodiola Rosea Simulation Capsule

Interventions

DaZhu Rhodiola Rosea CapsuleDRUG

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

DaZhu Rhodiola Rosea Capsule
DaZhu Rhodiola Rosea Simulation CapsuleDRUG

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

DaZhu Rhodiola Rosea Simulation Capsule

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, 100029, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Shao-Ping Nie, MD, PhD

CONTACT

86-10-84005256spnie@ccmu.edu.cn

Xiao Wang, MD

CONTACT

86-10-84005255spaceeye123@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, Director, Emergency & Critical Care Center

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 16, 2018

Study Start

August 1, 2018

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

August 16, 2018

Record last verified: 2018-08

Locations

CN(1)