Clinical Evaluation of Aromatic Wentong in the Treatment of Coronary Microvascular Disease

NCT ID: NCT06901570

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 528 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2028-07-31

Brief Summary

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.

Conditions

Coronary Microvascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental Arm

Group Type: EXPERIMENTAL

Kuangxiong Aerosol

Intervention Type: DRUG

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.

Control Arm

Group Type: PLACEBO_COMPARATOR

Placebo Drug

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Aged between 18 and 80 years, regardless of gender.
• Clinical symptoms of myocardial ischemia.
• Objective evidence of myocardial ischemia, including:

1. ECG changes during chest pain episodes,

2. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xianlun Li

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

China-Japan Friendship Hospital

Beijing, Chaoyang District, China

Countries

China

Central Contacts

Xianlun Li

Role: CONTACT

lixianlun@hotmail.com

13910812495

Danni Wu

Role: CONTACT

wudanni@student.pumc.edu.cn

13502622048

Facility Contacts

Xianlun Li

Role: primary

lixianlun@hotmail.com

13910812495

Danni Wu

Role: backup

wudanni@student.pumc.edu.cn

13502622048

Other Identifiers

2023ZD0505705

Identifier Type: -

Identifier Source: org_study_id