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.
Aged between 18 and 80 years, regardless of gender.
Clinical symptoms of myocardial ischemia.
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.
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.
Parallel
Kuangxiong Aerosol
DrugPatients 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
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.
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.
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.
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.
Levels of inflammatory factors (CRP, hs-CRP, IL-1β, IL-6)
Levels of vascular endothelial function markers (NO, ET-1)
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