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A Randomized Double-Blind Placebo-Controlled Multicenter Clinical Trial of Kuanxiong Aerosol in Patients with Myocardial Bridging and Angina Pectoris

A Randomized Double-Blind Placebo-Controlled Multicenter Clinical Trial of Kuanxiong Aerosol in Patients with Myocardial Bridging and Angina Pectoris

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002077
Enrollment
Unknown
Registered
2025-10-28
Start date
2025-11-15
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Bridging

Interventions

Sponsors

Zhongshan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age: 18–75 years (inclusive), regardless of gender. 2. Patients with angina or anginal equivalent symptoms (pressure-like discomfort in the chest, neck, jaw, shoulder, or arm; precipitated by physical exertion; relieved within 5 minutes by rest or nitroglycerin use) occurring at a frequency of =2 times per week. 3.Diagnosis: Confirmed myocardial bridge in the left anterior descending (LAD) artery via coronary angiography or coronary CTA, including: Patients with isolated myocardial bridge in the LAD artery; Patients with myocardial bridge in the LAD artery and <50% stenosis in all epicardial coronary arteries. 4.Consent: Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1.Coronary Stenosis: =50% stenosis in any epicardial coronary artery confirmed by coronary angiography or coronary CTA. 2.Recent ACS: Diagnosis of acute coronary syndrome (ACS) within the past 12 months. 3.Prior Revascularization: Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within the past 12 months. 4.Non-Cardiac Chest Pain: Comorbidities that may cause chest pain (e.g., severe pulmonary hypertension, severe aortic stenosis, or obstructive hypertrophic cardiomyopathy). 5.Severe Anemia: Hemoglobin 180 mmHg or diastolic blood pressure >110 mmHg. 8.Uncontrolled Arrhythmias: Hemodynamically unstable arrhythmias (e.g., rapid atrial fibrillation, supraventricular tachycardia, high-grade atrioventricular block). 9.Recent Medication Use: Use of ß-blockers, calcium channel blockers, Kuanxiong Aerosol, or herbal preparations (e.g., Tongxinluo, Shexiang Baoxin Pills, Compound Danshen Dripping Pills) within 2 weeks prior to enrollment. *Note: A 2-week washout period is required; eligibility may be reassessed thereafter. 10.Allergy History: Hypersensitivity to alcohol or components of Kuanxiong Aerosol (including documented allergy or prior allergic reactions). 11.Severe Systemic Diseases: Active malignancy or other severe systemic disorders. 12.Pregnancy: Pregnant women or women planning pregnancy. 13.Concurrent Trials: Participation in another clinical trial or prior randomization in this study within 30 days before screening. 14.Investigator Discretion: Patients deemed ineligible by the investigator.

Design outcomes

Primary

MeasureTime frame
Seattle Angina Questionnaire (SAQ);

Secondary

MeasureTime frame
Anxiety/Depression Scales: Generalized Anxiety Disorder-7 (GAD-7) Patient Health Questionnaire-9 (PHQ-9);Treadmill Exercise Testing;Frequency of Angina Episodes;Seattle Angina Questionnaire (SAQ);12-Item Short Form Survey (SF-12 );Cardiopulmonary Exercise Testing;

Countries

China

Contacts

Public ContactJunboGe

Zhongshan Hospital

Ge.junbo@zs-hospital.sh.cn19700736195

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026