Clinical Assessment of Aromatic Wentong for Coronary Microvascular Disease Management
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 528
- 试验地点
- 1
- 主要终点
- Score of the Seattle Angina Questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental Arm
干预措施: Kuangxiong Aerosol (Drug)
Control Arm
干预措施: Placebo Drug (Drug)
结局指标
主要结局
Score of the Seattle Angina Questionnaire
时间窗: 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.
次要结局
- Factors and levels of proteomics(Baseline, 8 weeks)
- Score of the Traditional Chinese Medicine Syndrome Score Scale(Baseline, 4 weeks, and 8 weeks.)
- Score of the Medical Outcomes Study 36-Item Short-Form Health Survey(Baseline, 4 weeks, and 8 weeks)
- Levels of inflammatory factors (CRP, hs-CRP, IL-1β, IL-6)(Baseline, 8 weeks)
- Levels of vascular endothelial function markers (NO, ET-1)(Baseline, 8 weeks)
- Factors and levels of transcriptomics(Baseline, 8 weeks)
- Factors and levels of metabolomics(Baseline, 8 weeks)
- Myocardial contrast echocardiography(Baseline, 8 weeks)
- Major adverse cardiovascular events(8 weeks)
研究者
Xianlun Li
Principal Investigator
China-Japan Friendship Hospital