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A clinical trial of Kuang Xiong aerosol for reliefing clinical symptoms and improving quality of life in patients with coronary microvascular disease (CMVD)

A clinical trial of Kuang Xiong aerosol for reliefing clinical symptoms and improving quality of life in patients with coronary microvascular disease (CMVD)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046583
Enrollment
Unknown
Registered
2021-05-22
Start date
2021-06-01
Completion date
Unknown
Last updated
2022-01-04

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

Conditions

Coronary arteries are vascular diseases

Interventions

Sponsors

Zhongshan Hoapital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet one of the following four items: (1) Spontaneous or exertional chest pain with ST-segment depression of ECG, the application of nitrate ester drugs is ineffective (the most common); (2) Myocardial stress perfusion realizes reversible perfusion defect; (3) Cardiac MRI and ultrasound suggest evidence of load-related coronary blood flow abnormalities; (4) Metabolic evidence of transient myocardial ischemia (confirmed by cardiac MRI or invasive examination); 2. Coronary angiography or coronary CTA showed mild stenosis of the main branch vessels (<50%); or PCI was performed within 3 years, but the main branch vessels were mildly stented (<50%); 3. Patients between the ages of 18-65 (including 18 and 65 years old) are not limited to men and women; 4. The patient voluntarily followed up and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who are allergic to Kuanxiong aerosol or its components (asarum oil, sandalwood oil, galangal oil, long pepper oil, borneol) or any component of the drug; 2. Persistent severe angina pectoris (CCS grade IV); 3. Severe ST-segment depression during exercise test level 1 in the past month; 4. Patients with heart failure with left ventricular ejection fraction (LVEF) 400pg/ml; 5. Prepare to perform CABG or PCI during the test; 6. The four criteria of blood fat, blood sugar, blood pressure and uric acid: (1) With or without drug control, blood lipid exceeds 1.5 times the upper limit of the normal reference value; (2) Diabetic patients with poor blood glucose control (patients with previous diagnosis of diabetes had HbA1c >6.5% before participating in this study;Had not been diagnosed with diabetes before, and it was found that diabetic patients had HbA1c >7.5% during screening); (3) uncontrolled severe hypertension, systolic blood pressure > 180mmHg and/or diastolic blood pressure > 110mmHg; (4) Uric acid exceeds 1.5 times the upper limit of the normal reference value; 7. Renal dysfunction (CR > 1.5 times the upper limit of the normal reference value) 8. Patients with severe liver disease or liver dysfunction (ALT, AST or TBIL>1.5 times the upper limit of the normal reference value); 9. Any other serious disease or condition such as malignancy; 10. Severe arrhythmias (such as rapid atrial fibrillation, ventricular tachycardia, high atrioventricular block, etc.); 11. Participated in another clinical study or had been randomized to the study within 30 days prior to enrollment; 12. A woman who is pregnant or preparing to become pregnant; 13. Patients determined by the investigator to be unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Changes of Seattle Angina Scale;

Secondary

MeasureTime frame
ECG changes (ST-T segment changes);Changes of cardiac function indexes (LVEF, LVEDD);Changs of BNP;Changes of Troponin T;Changes of blood lipid;C-reactive protein changes;Changes in the Quality of Life Scale (SF-12);Changes in the Depression Screening Scale(PHQ-9);Changes in the Panic Disorder Severity Scale;Changse in the Anxiety Screening Scale;Changes in the Life event scale;

Countries

China

Contacts

Public ContactPeng Juan

Zhongshan Hospital, Fudan University

peng.juan@zs-hospital.sn.cn+86 21 64041990

Outcome results

None listed

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