Coronary Artery DiseasePhase 4NCT03633890
DaZhu Rhodiola Rosea Capsule for Coronary Artery Disease With Angina Pectoris
A Phase 4 study testing DaZhu Rhodiola Rosea Capsule and DaZhu Rhodiola Rosea Simulation Capsule in people with Coronary Artery Disease, run by Beijing Anzhen Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- DaZhu Rhodiola Rosea Capsule and DaZhu Rhodiola Rosea Simulation Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- Aug 2018to Feb 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Anzhen Hospital, Capital Medical University
Beijing, 100029
Shao-Ping Nie, MD, PhD, 86-10-84005256, spnie@ccmu.edu.cn
Shao-Ping Nie, MD, PhD
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial for DaZhu Rhodiola Rosea Capsule in the Treatment of Coronary Artery Disease With Angina Pectoris
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.
- Conditions
- Coronary Artery Disease
- Being tested
- DaZhu Rhodiola Rosea Capsule, DaZhu Rhodiola Rosea Simulation Capsule
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaZhu Rhodiola Rosea CapsuleDrug
Oral administration, 4 capsules, 3 times a day, for 8 weeks
DaZhu Rhodiola Rosea Simulation CapsuleDrug
Oral administration, 4 capsules, 3 times a day, for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| DaZhu Rhodiola Rosea Capsule | Experimental | Not described Receives: Drug: DaZhu Rhodiola Rosea Capsule |
| DaZhu Rhodiola Rosea Simulation Capsule | Placebo comparator | Not described Receives: Drug: DaZhu Rhodiola Rosea Simulation Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seattle Angina Questionnaire (SAQ) angina frequency
Scored from 0 to 100, with higher scores indicating better health status
Measured: week 8
Secondary outcomes (8)
SAQ angina stability
Scored from 0 to 100, with higher scores indicating better health status
Measured: week 8
SAQ physical limitation
Scored from 0 to 100, with higher scores indicating better health status
Measured: week 8
SAQ treatment satisfaction
Scored from 0 to 100, with higher scores indicating better health status
Measured: week 8
SAQ disease perception
Scored from 0 to 100, with higher scores indicating better health status
Measured: week 8
Walking distance by 6-minute walking test
Measured: week 8
Frequency of angina
Measured: week 8
visual analogue scale (VAS) score
Scored from 0 to 10, with higher scores indicating worse health status
Measured: week 8
36-item Short Form Health Survey (SF-36) score
Scored from 36 to 180, with higher scores indicating better health status
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study startAug 2018 (estimated)
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Kangyuan Pharmaceutical Co. Ltd
- Responsible party
- Principal investigator, Shao-Ping Nie, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633890
- Sponsor's protocol ID
- 2017032
- Status last verified
- Aug 2018
- First submitted
- 7 Aug 2018
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial for DaZhu Rhodiola Rosea Capsule in the Treatment of Coronary Artery Disease With Angina Pectoris
- ClinicalTrials.gov ID
- NCT03633890
- Acronym / sponsor ID
- 2017032
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Collaborators
- Jiangsu Kangyuan Pharmaceutical Co. Ltd
- Study start
- Aug 2018 (estimated)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DaZhu Rhodiola Rosea Capsule | Experimental | Drug: DaZhu Rhodiola Rosea Capsule |
| DaZhu Rhodiola Rosea Simulation Capsule | Placebo comparator | Drug: DaZhu Rhodiola Rosea Simulation Capsule |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaZhu Rhodiola Rosea CapsuleOral administration, 4 capsules, 3 times a day, for 8 weeks | Drug | DaZhu Rhodiola Rosea Capsule |
| DaZhu Rhodiola Rosea Simulation CapsuleOral administration, 4 capsules, 3 times a day, for 8 weeks | Drug | DaZhu Rhodiola Rosea Simulation Capsule |
Primary outcome
Seattle Angina Questionnaire (SAQ) angina frequency
Time frame: week 8
Scored from 0 to 100, with higher scores indicating better health status
8 secondary outcomes
SAQ angina stability
Time frame: week 8
SAQ physical limitation
Time frame: week 8
SAQ treatment satisfaction
Time frame: week 8
SAQ disease perception
Time frame: week 8
Walking distance by 6-minute walking test
Time frame: week 8
Frequency of angina
Time frame: week 8
visual analogue scale (VAS) score
Time frame: week 8
36-item Short Form Health Survey (SF-36) score
Time frame: week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DaZhu Rhodiola Rosea Capsule and DaZhu Rhodiola Rosea Simulation Capsule in people with Coronary Artery Disease, run by Beijing Anzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shao-Ping Nie, MD, PhD (86-10-84005256, spnie@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seattle Angina Questionnaire (SAQ) angina frequency (time frame: week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.