Coronary Microvascular DiseasePhase 2/3NCT04218916
Rhodiola Rosea for Coronary Microvascular Disease
A Phase 2/3 study testing Rhodiola Rosea Capsules in people with Coronary Microvascular Disease, run by Qilu Hospital of Shandong University.
Trial summary
To investigate the effects of rhodiola rosea on coronary flow reserve and symptoms in patients with microvascular angina pectoris, and to evaluate adverse drug reactions. Long-term clinical follow-up of 1 to 3 years was conducted to evaluate the effect of rhodiola rosea on long-term adverse cardiovascular events in… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Coronary Microvascular Disease
- What is being tested?
- Rhodiola Rosea Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Jan 2023
- Phase
- Phase 2/3
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks;
- Coronary normal or stenosis < 20%;
- Ischemic depression in ST segment during resting or exercise;
- Blood flow reserve (CFR) of the anterior descending coronary artery < 2.0;
- Subjects or their guardians agreed to participate in this study.
Who cannot join
- Previous myocardial infarction or PCI or CABG treatment;
- A history of heart failure or LVEF < 50%;
- Severe arrhythmia;
- Myocarditis, Pericardium Disease, Valvular Disease, or Cardiomyopathy;
- A history of stroke within half a year;
- Diabetes difficult to control;
Show all 15Show fewer
- Refractory hypertension or hypertension accompanied by left ventricular wall thickness > 12 mm;
- Familial hypercholesterolemia;
- Takayasu arteritis, Kawasaki disease or coronary artery malformation;
- Pregnant or nursing, or having the intention to give birth within one year;
- Hepatic or renal dysfunction;
- Other diseases which may cause serious risks to patients;
- Requiring warfarin anticoagulant therapy; Taking potassium channel opener, CCB, ACEI drugs or traditional Chinese medicines;
- Allergic to contrast agents or blood products;
- Patients who participated in clinical research of other drugs within 3 months before being selected.
About this study
Official title: The Efficacy and Safety of Rhodiola Rosea in Patients With Coronary Microvascular Disease
To investigate the effects of rhodiola rosea on coronary flow reserve and symptoms in patients with microvascular angina pectoris, and to evaluate adverse drug reactions. Long-term clinical follow-up of 1 to 3 years was conducted to evaluate the effect of rhodiola rosea on long-term adverse cardiovascular events in patients with coronary microvascular disease.
- Conditions
- Coronary Microvascular Disease
- Being tested
- Rhodiola Rosea Capsules, Placebo
- Medical subject headings
- Microvascular Angina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhodiola Rosea CapsulesDrug
0.28g per capsule, 0.56g once (2 capsules), three times a day
PlaceboDrug
2 placebo capsules once, three times a day
| Study group | Role | What they receive |
|---|---|---|
| Rhodiola Rosea Capsule | Experimental | Not described Receives: Drug: Rhodiola Rosea Capsules |
| Placebo Capsule | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Coronary Flow Reserve
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study startJan 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Microvascular DiseaseStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan-Pan Hao, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218916
- Sponsor's protocol ID
- Qilu Hospital
- Status last verified
- Jan 2020
- First submitted
- 3 Jan 2020
- Last updated
- 6 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Rhodiola Rosea in Patients With Coronary Microvascular Disease
- ClinicalTrials.gov ID
- NCT04218916
- Acronym / sponsor ID
- Qilu Hospital
- Conditions
- Coronary Microvascular Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 6 Jan 2020 (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.
To investigate the effects of rhodiola rosea on coronary flow reserve and symptoms in patients with microvascular angina pectoris, and to evaluate adverse drug reactions. Long-term clinical follow-up of 1 to 3 years was conducted to evaluate the effect of rhodiola rosea on long-term adverse cardiovascular events in patients with coronary microvascular disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhodiola Rosea Capsule | Experimental | Drug: Rhodiola Rosea Capsules |
| Placebo Capsule | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks;
- Coronary normal or stenosis < 20%;
- Ischemic depression in ST segment during resting or exercise;
- Blood flow reserve (CFR) of the anterior descending coronary artery < 2.0;
- Subjects or their guardians agreed to participate in this study.
Key exclusion criteria (15 listed)
- Previous myocardial infarction or PCI or CABG treatment;
- A history of heart failure or LVEF < 50%;
- Severe arrhythmia;
- Myocarditis, Pericardium Disease, Valvular Disease, or Cardiomyopathy;
- A history of stroke within half a year;
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 |
|---|---|---|
| Rhodiola Rosea Capsules0.28g per capsule, 0.56g once (2 capsules), three times a day | Drug | Rhodiola Rosea Capsule |
| Placebo2 placebo capsules once, three times a day | Drug | Placebo Capsule |
Primary outcome
Changes of Coronary Flow Reserve
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
Related trials for Coronary Microvascular Disease
Active, not recruiting
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
Coronary Microvascular Disease, Ischemic Heart Disease
Active, not recruitingObservational study
The Role of CD34+ Stem Cells in the Pathogenesis of Takotsubo Syndrome
Tako Tsubo Cardiomyopathy, Microvascular Dysfunction
Recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
RecruitingObservational study
Mechanical Dyssynchrony and Microvascular Dysfunction by SPECT
Myocardial Blood Flow Reserve, Mechanical Dyssynchrony
Enrolling by invitationObservational study
Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study
Non-obstructive Coronary Disease, Acute or Chronic Coronary Artery Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rhodiola Rosea Capsules in people with Coronary Microvascular Disease, run by Qilu Hospital of Shandong University.
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 5 inclusion and 15 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 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Coronary Flow Reserve (time frame: 1 year). 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 6 Jan 2020.