Coronary Microvascular DiseasePhase 4NCT06901570
Clinical Evaluation of Aromatic Wentong in the Treatment of Coronary Microvascular Disease
A Phase 4 study testing Kuangxiong Aerosol in people with Coronary Microvascular Disease, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
Coronary Microvascular Disease (CMD) is a condition where patients experience chest pain (angina) even though their coronary arteries appear normal on angiography. It is common among people with coronary heart disease, especially those with chest pain as their main symptom. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Microvascular Disease
- What is being tested?
- Kuangxiong Aerosol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 528 participants
- Where
- 1 siteChina
- Study dates
- Apr 2025to Jul 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 80 years, regardless of gender.
- Clinical symptoms of myocardial ischemia.
- Objective evidence of myocardial ischemia, including:
- ECG changes during chest pain episodes,
- Stress test-induced chest pain symptoms and/or abnormal myocardial blood flow and/or abnormal cardiac wall motion with ischemic ECG changes.
- Coronary angiography (CAG) showing >50% reduction in the diameter of the epicardial coronary artery.
Show all 9Show fewer
- QFR > 0.80 and AMR > 2.5 mmHg·s/cm.
- Discontinuation of all Chinese medicine interventions for at least two weeks prior to enrollment.
- Provision of informed consent and a signed informed consent form.
Who cannot join
- Significant liver or kidney dysfunction, defined as ALT, AST, or blood creatinine levels >3 times the upper limit of normal.
- Severe cardiac conditions, including heart failure, myocarditis, cardiomyopathy, acute pericarditis, structural heart disease.
- Severe systemic diseases, such as severe mental illness, hematopoietic system disorders, or malignant tumors.
- Suspected or confirmed allergy to the trial drug.
- Individuals deemed by researchers to be unsuitable for participation in the clinical trial.
- Women who are pregnant, planning to become pregnant, or currently lactating.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
China-Japan Friendship Hospital
Beijing, Chaoyang District, 100029
Xianlun Li, 13910812495, lixianlun@hotmail.com
Danni Wu, 13502622048, wudanni@student.pumc.edu.cn
About this study
Official title: Clinical Assessment of Aromatic Wentong for Coronary Microvascular Disease Management
Coronary Microvascular Disease (CMD) is a condition where patients experience chest pain (angina) even though their coronary arteries appear normal on angiography. It is common among people with coronary heart disease, especially those with chest pain as their main symptom. Unfortunately, there are no effective treatments available for these patients, and symptoms like chest tightness and persistent pain greatly affect their quality of life.
Traditional Chinese Medicine (TCM) suggests that the root cause of microvascular disease is blocked collateral blood vessels. Aromatic Wentong, a TCM approach, aims to improve blood flow and relieve blockages. Kuangxiong Aerosol is a Chinese patent medicine developed based on the principles of Aromatic Wentong.
Read more
This study is a multicenter, randomized, double-blind, placebo-controlled trial involving 528 patients with chest pain and suspected CMD. Participants are recruited from several hospitals, including China-Japan Friendship Hospital, Fuwai Hospital, and Xiyuan Hospital. Patients are randomly divided into two groups:
The intervention group receives standard guideline-recommended treatment plus Kuangxiong Aerosol.
The control group receives standard treatment plus a placebo version of Kuangxiong Aerosol.
The treatment lasts for 8 weeks.
- Conditions
- Coronary Microvascular Disease
- Being tested
- Kuangxiong Aerosol, Placebo Drug
- Medical subject headings
- Microvascular Angina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kuangxiong AerosolDrug
Patients in the intervention group will receive Kuangxiong Aerosol for eight weeks, in addition to guideline-recommended medications. The aerosol will be administered sublingually (under the tongue), with a dosage of two sprays per dose, three times daily.
Placebo DrugDrug
Patients in the control group will receive a placebo version of Kuangxiong Aerosol for eight weeks, alongside guideline-recommended medications. The placebo will be administered sublingually (under the tongue), with a dosage of two sprays per dose, three times daily.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Not described Receives: Drug: Kuangxiong Aerosol |
| Control Arm | Placebo comparator | Not described Receives: Drug: Placebo Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of the Seattle Angina Questionnaire
The Seattle Angina Questionnaire (SAQ) is a 19-item self-administered, disease-specific patient-reported outcome with 5 domains: physical limitation (Question 1), anginal stability (Question 2), anginal frequency (Question 3), treatment satisfaction (Question 4-8), and disease perception/quality of life (Question 9-11). All SAQ domain scores and the summary score range from 0 to 100 with higher scores indicating less angina, fewer functional limitations, and better quality of life.
Measured: Baseline, 4 weeks, and 8 weeks
Secondary outcomes (9)
Score of the Traditional Chinese Medicine Syndrome Score Scale
The Traditional Chinese Medicine Syndrome Score Scale is a scale based on patients' syndromes and signs, and it varies depending on the disease and context. In this study, the Traditional Chinese Medicine Syndrome Score Scale consists of 14 items, each scored from 0 to 4. The sum of all items represents the final score, where a higher score indicates worse symptoms and a lower score indicates better symptoms.
Measured: Baseline, 4 weeks, and 8 weeks.
Score of the Medical Outcomes Study 36-Item Short-Form Health Survey
The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) includes eight scaled scores: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. The scores are weighted sums of the questions in each section. Scores range from 0 to 100, where lower scores indicate more disability and higher scores indicate less disability.
Measured: Baseline, 4 weeks, and 8 weeks
Levels of inflammatory factors (CRP, hs-CRP, IL-1β, IL-6)
Measured: Baseline, 8 weeks
Levels of vascular endothelial function markers (NO, ET-1)
Measured: Baseline, 8 weeks
Factors and levels of transcriptomics
Measured: Baseline, 8 weeks
Factors and levels of proteomics
Measured: Baseline, 8 weeks
Factors and levels of metabolomics
Measured: Baseline, 8 weeks
Myocardial contrast echocardiography
A subset of 40 patients from each group will undergo myocardial contrast echocardiography to assess myocardial blood flow and coronary flow reserve.
Measured: Baseline, 8 weeks
Major adverse cardiovascular events
The major adverse cardiovascular events are defined by the combination of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, rehospitalization for heart failure, or unstable angina pectoris.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study startApr 2025 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (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 China-Japan Friendship 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 528 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianlun Li, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901570
- Sponsor's protocol ID
- 2023ZD0505705
- Status last verified
- Apr 2025
- First submitted
- 11 Mar 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Aromatic Wentong for Coronary Microvascular Disease Management
- ClinicalTrials.gov ID
- NCT06901570
- Acronym / sponsor ID
- 2023ZD0505705
- Conditions
- Coronary Microvascular Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 528 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 30 Mar 2025 (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.
Coronary Microvascular Disease (CMD) is a condition where patients experience chest pain (angina) even though their coronary arteries appear normal on angiography. It is common among people with coronary heart disease, especially those with chest pain as their main symptom. Unfortunately, there are no effective treatments available for these patients, and symptoms like chest tightness and persistent pain greatly affect their quality of life.
Traditional Chinese Medicine (TCM) suggests that the root cause of microvascular disease is blocked collateral blood vessels. Aromatic Wentong, a TCM approach, aims to improve blood flow and relieve blockages. Kuangxiong Aerosol is a Chinese patent medicine developed based on the principles of Aromatic Wentong.
This study is a multicenter, randomized, double-blind, placebo-controlled trial involving 528 patients with chest pain and suspected CMD. Participants are recruited from several hospitals, including China-Japan Friendship Hospital, Fuwai Hospital, and Xiyuan Hospital. Patients are randomly divided into two groups:
The intervention group receives standard guideline-recommended treatment plus Kuangxiong Aerosol.
The control group receives standard treatment plus a placebo version of Kuangxiong Aerosol.
The treatment lasts for 8 weeks.
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 |
|---|---|---|
| Experimental Arm | Experimental | Drug: Kuangxiong Aerosol |
| Control Arm | Placebo comparator | Drug: Placebo Drug |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged between 18 and 80 years, regardless of gender.
- Clinical symptoms of myocardial ischemia.
- Objective evidence of myocardial ischemia, including:
- Coronary angiography (CAG) showing >50% reduction in the diameter of the epicardial coronary artery.
- QFR > 0.80 and AMR > 2.5 mmHg·s/cm.
Key exclusion criteria (6 listed)
- Significant liver or kidney dysfunction, defined as ALT, AST, or blood creatinine levels >3 times the upper limit of normal.
- Severe cardiac conditions, including heart failure, myocarditis, cardiomyopathy, acute pericarditis, structural heart disease.
- Severe systemic diseases, such as severe mental illness, hematopoietic system disorders, or malignant tumors.
- Suspected or confirmed allergy to the trial drug.
- Individuals deemed by researchers to be unsuitable for participation in the clinical trial.
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 |
|---|---|---|
| Kuangxiong AerosolPatients in the intervention group will receive Kuangxiong Aerosol for eight weeks, in addition to guideline-recommended medications. The aerosol will be administered sublingually (under the tongue), with a dosage of two sprays per dose, three times daily. | Drug | Experimental Arm |
| Placebo DrugPatients in the control group will receive a placebo version of Kuangxiong Aerosol for eight weeks, alongside guideline-recommended medications. The placebo will be administered sublingually (under the tongue), with a dosage of two sprays per dose, three times daily. | Drug | Control Arm |
Primary outcome
Score of the Seattle Angina Questionnaire
Time frame: Baseline, 4 weeks, and 8 weeks
The Seattle Angina Questionnaire (SAQ) is a 19-item self-administered, disease-specific patient-reported outcome with 5 domains: physical limitation (Question 1), anginal stability (Question 2), anginal frequency (Question 3), treatment satisfaction (Question 4-8), and disease perception/quality of life (Question 9-11). All SAQ domain scores and the summary score range from 0 to 100 with higher scores indicating less angina, fewer functional limitations, and better quality of life.
9 secondary outcomes
Score of the Traditional Chinese Medicine Syndrome Score Scale
Time frame: Baseline, 4 weeks, and 8 weeks.
Score of the Medical Outcomes Study 36-Item Short-Form Health Survey
Time frame: Baseline, 4 weeks, and 8 weeks
Levels of inflammatory factors (CRP, hs-CRP, IL-1β, IL-6)
Time frame: Baseline, 8 weeks
Levels of vascular endothelial function markers (NO, ET-1)
Time frame: Baseline, 8 weeks
Factors and levels of transcriptomics
Time frame: Baseline, 8 weeks
Factors and levels of proteomics
Time frame: Baseline, 8 weeks
Factors and levels of metabolomics
Time frame: Baseline, 8 weeks
Myocardial contrast echocardiography
Time frame: Baseline, 8 weeks
Major adverse cardiovascular events
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: No
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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.
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 Kuangxiong Aerosol in people with Coronary Microvascular Disease, run by China-Japan Friendship 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 9 inclusion and 6 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: opening soon, as of the sponsor's last update on 11 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xianlun Li (13910812495, lixianlun@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of the Seattle Angina Questionnaire (time frame: Baseline, 4 weeks, and 8 weeks). 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 11 Apr 2025.