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

Clinical Assessment of Aromatic Wentong for Coronary Microvascular Disease Management

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Microvascular Disease
• Intervention / Treatment: Drug: Kuangxiong Aerosol; Drug: Placebo Drug

• Study Type: Interventional
• Enrollment (Estimated): 528
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xianlun Li; Phone Number: 13910812495; Email: lixianlun@hotmail.com
• Study Contact Backup: Name: Danni Wu; Phone Number: 13502622048; Email: wudanni@student.pumc.edu.cn

Study Locations

• China
  • Chaoyang District
    • Beijing, Chaoyang District, China, 100029
      • China-Japan Friendship Hospital
      • Contact: Xianlun Li; Phone Number: 13910812495; Email: lixianlun@hotmail.com
      • Contact: Danni Wu; Phone Number: 13502622048; Email: wudanni@student.pumc.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Arm	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.
Experimental: Experimental Arm	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of the Seattle Angina Questionnaire	The Seattle Angina Questionnaire (SAQ) is a 19-item self-administered, disease-specific patient-reported outcome with 5 domains: physical limitation (Question 1), anginal stability (Question 2), anginal frequency (Question 3), treatment satisfaction (Question 4-8), and disease perception/quality of life (Question 9-11). All SAQ domain scores and the summary score range from 0 to 100 with higher scores indicating less angina, fewer functional limitations, and better quality of life.	Baseline, 4 weeks, and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of the Traditional Chinese Medicine Syndrome Score Scale	The Traditional Chinese Medicine Syndrome Score Scale is a scale based on patients' syndromes and signs, and it varies depending on the disease and context. In this study, the Traditional Chinese Medicine Syndrome Score Scale consists of 14 items, each scored from 0 to 4. The sum of all items represents the final score, where a higher score indicates worse symptoms and a lower score indicates better symptoms.	Baseline, 4 weeks, and 8 weeks.
Score of the Medical Outcomes Study 36-Item Short-Form Health Survey	The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) includes eight scaled scores: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. The scores are weighted sums of the questions in each section. Scores range from 0 to 100, where lower scores indicate more disability and higher scores indicate less disability.	Baseline, 4 weeks, and 8 weeks
Levels of inflammatory factors (CRP, hs-CRP, IL-1β, IL-6)		Baseline, 8 weeks
Levels of vascular endothelial function markers (NO, ET-1)		Baseline, 8 weeks
Factors and levels of transcriptomics		Baseline, 8 weeks
Factors and levels of proteomics		Baseline, 8 weeks
Factors and levels of metabolomics		Baseline, 8 weeks
Myocardial contrast echocardiography	A subset of 40 patients from each group will undergo myocardial contrast echocardiography to assess myocardial blood flow and coronary flow reserve.	Baseline, 8 weeks
Major adverse cardiovascular events	The major adverse cardiovascular events are defined by the combination of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, rehospitalization for heart failure, or unstable angina pectoris.	8 weeks

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Angina Pectoris; Microvascular Angina
• Other Study ID Numbers: 2023ZD0505705

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No