Clinical Evaluation of Aromatic Wentong in the Treatment of Coronary Microvascular Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Kuangxiong Aerosol, Placebo Drug.
- Who it may be relevant to
- Registry conditions: Coronary Microvascular Disease. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Assessment of Aromatic Wentong for Coronary Microvascular Disease Management
Overview
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.
Interventions
- 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. - Drug 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.
Primary outcome measures
- Score of the Seattle Angina Questionnaire [Time frame: Baseline, 4 weeks, and 8 weeks]
Secondary outcome measures (9)
- Score of the Traditional Chinese Medicine Syndrome Score Scale [Time frame: Baseline, 4 weeks, and 8 weeks.]
- Score of the Medical Outcomes Study 36-Item Short-Form Health Survey [Time frame: Baseline, 4 weeks, and 8 weeks]
- Levels of inflammatory factors (CRP, hs-CRP, IL-1β, IL-6) [Time frame: Baseline, 8 weeks]
- Levels of vascular endothelial function markers (NO, ET-1) [Time frame: Baseline, 8 weeks]
- Factors and levels of transcriptomics [Time frame: Baseline, 8 weeks]
- Factors and levels of proteomics [Time frame: Baseline, 8 weeks]
- Factors and levels of metabolomics [Time frame: Baseline, 8 weeks]
- Myocardial contrast echocardiography [Time frame: Baseline, 8 weeks]
- Major adverse cardiovascular events [Time frame: 8 weeks]
Eligibility criteria
Inclusion criteria
- 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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- China-Japan Friendship Hospital — Beijing
Identifiers
NCT: NCT06901570 · 2023ZD0505705