Clinical Evaluation of Aromatic Wentong in the Treatment of Coronary Microvascular Disease

Launched by CHINA-JAPAN FRIENDSHIP HOSPITAL · Mar 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Kuangxiong Aerosol, based on Traditional Chinese Medicine, for patients with Coronary Microvascular Disease (CMD). CMD is a condition where patients have chest pain despite having normal-looking coronary arteries, and current treatments are limited. The goal of this trial is to see if Kuangxiong Aerosol, combined with standard treatments, can improve blood flow and reduce symptoms like chest pain.

To participate in the trial, individuals must be between the ages of 18 and 80 and have symptoms indicating a lack of blood flow to the heart, backed by specific test results. Patients will be randomly assigned to receive either the Kuangxiong Aerosol or a placebo (a treatment with no active ingredients) for 8 weeks while continuing their standard care. The trial aims to involve 528 participants from several hospitals, and it is not yet recruiting. If you're interested or think you might qualify, it's important to discuss it with your healthcare provider.

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Eligibility criteria

• Inclusion Criteria:
• • Aged between 18 and 80 years, regardless of gender.
• • Clinical symptoms of myocardial ischemia.
• * Objective evidence of myocardial ischemia, including:
• • 1. ECG changes during chest pain episodes,
• • 2. 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.
• Exclusion Criteria:
• • 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.