NCT06901570Not yet recruitingPhase 4
Clinical Evaluation of Aromatic Wentong in the Treatment of Coronary Microvascular Disease
Clinical Assessment of Aromatic Wentong for Coronary Microvascular Disease Management
Source: ClinicalTrials.gov · Last updated 11 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 528 (estimated)
- First submitted
- 11 Mar 2025
- Start date
- Apr 2025
- Primary completion date
- Jul 2028
- Lead sponsor
- China-Japan Friendship Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT06901570
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 528
- From Apr 2025 to the primary completion date, Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- Significant liver or kidney dysfunction, defined as ALT, AST, or blood creatinine levels \>3 times the upper limit of normal.
Other
- Individuals deemed by researchers to be unsuitable for participation in the clinical trial.
- Women who are pregnant, planning to become pregnant, or currently lactating.
Who the study is looking for
- 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.
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.