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

NCT06901570 · tracked via the Priya Life Science China tracker

Sponsor

China-Japan Friendship Hospital

Phase

Phase 4

Started

2025-04

Last updated

2025-04-11

Condition(s) studied

Coronary Microvascular Disease

Investigational drug(s) / intervention(s)

Kuangxiong AerosolPlacebo Drug

Kuangxiong Aerosol: 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 Drug: 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 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. 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

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.

Primary outcome measure(s)

Score of the Seattle Angina Questionnaire — 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.

Trial sites (1)

Facility	City	Region	Status
China-Japan Friendship Hospital	Beijing	Chaoyang District

More China-Japan Friendship Hospital trials in China

PCT Guided Antibiotics Use in Critically Ill Adult Patients in China Starting soon

Radiomics of Intra-abdominal and Subcutaneous Adipose Tissue Predict the Efficacy of Bariatric Surgery (RISABS) Recruiting

A Prediction Model of Prolonged Mechanical Ventilation Following Acute Type A Aortic Dissection Surgery Starting soon

A Single-center, Prospective Study for Mechanism and Risk Factors of Tracheal Tube-related Tongue Injury Active, not recruiting

Application of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis Recruiting

Other trials for the same condition

An Observational Study of Coronary Microvascular Disease of China Recruiting

Qishenyiqi Dripping Pill for Coronary Microvascular Disease Recruiting

A Clinical Study of Fundus OCTA for the Identification of CMD Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06901570 on ClinicalTrials.gov ↗ ← All trials in China