Clinical trial NCT06901570: Clinical Evaluation of Aromatic Wentong in the Treatment of Coronary Microvascular Disease
Official title: Clinical Assessment of Aromatic Wentong for Coronary Microvascular Disease Management
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Coronary Microvascular Disease
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 528
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Score of the Seattle Angina Questionnaire
timeFrame: Baseline, 4 weeks, and 8 weeks
Secondary outcomes:
measure: Score of the Traditional Chinese Medicine Syndrome Score Scale
timeFrame: Baseline, 4 weeks, and 8 weeks.
measure: Score of the Medical Outcomes Study 36-Item Short-Form Health Survey
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Levels of inflammatory factors (CRP, hs-CRP, IL-1β, IL-6)
timeFrame: Baseline, 8 weeks
measure: Levels of vascular endothelial function markers (NO, ET-1)
timeFrame: Baseline, 8 weeks
measure: Factors and levels of transcriptomics
timeFrame: Baseline, 8 weeks
measure: Factors and levels of proteomics
timeFrame: Baseline, 8 weeks
measure: Factors and levels of metabolomics
timeFrame: Baseline, 8 weeks
measure: Myocardial contrast echocardiography
timeFrame: Baseline, 8 weeks
measure: Major adverse cardiovascular events
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Chaoyang District
Study officials:
References: