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

China-Japan Friendship Hospital

Status and phase

Not yet enrolling

Phase 4

Conditions

Coronary Microvascular Disease

Treatments

Drug: Placebo Drug

Drug: Kuangxiong Aerosol

Study type

Interventional

Funder types

Other

Identifiers

NCT06901570

2023ZD0505705

Details and patient eligibility

About

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.

Enrollment

528 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.