Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06901570

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Coronary Microvascular Disease Angina Pectoris Cardiovascular Diseases Heart Diseases Microvascular Angina Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 18 and 80 years, regardless of gender.
  • Clinical symptoms of myocardial ischemia.
  • Objective evidence of myocardial ischemia, including:
  • ECG changes during chest pain episodes,
  • 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.

Treatment and study plan

Kuangxiong Aerosol

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.

Placebo drug

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.

Primary outcomes

  1. Score of the Seattle Angina Questionnaire

    Time frame: Baseline, 4 weeks, and 8 weeks

    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.

Secondary outcomes

  1. Score of the Traditional Chinese Medicine Syndrome Score Scale

    Time frame: Baseline, 4 weeks, and 8 weeks.

    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.

  2. Score of the Medical Outcomes Study 36-Item Short-Form Health Survey

    Time frame: Baseline, 4 weeks, and 8 weeks

    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.

  3. Levels of inflammatory factors (CRP, hs-CRP, IL-1β, IL-6)

    Time frame: Baseline, 8 weeks

  4. Levels of vascular endothelial function markers (NO, ET-1)

    Time frame: Baseline, 8 weeks

  5. Factors and levels of transcriptomics

    Time frame: Baseline, 8 weeks

  6. Factors and levels of proteomics

    Time frame: Baseline, 8 weeks

  7. Factors and levels of metabolomics

    Time frame: Baseline, 8 weeks

  8. Myocardial contrast echocardiography

    Time frame: Baseline, 8 weeks

    A subset of 40 patients from each group will undergo myocardial contrast echocardiography to assess myocardial blood flow and coronary flow reserve.

  9. Major adverse cardiovascular events

    Time frame: 8 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Danni Wu

CONTACT

[email protected]

13502622048

Xianlun Li

CONTACT

[email protected]

13910812495

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study title

Clinical Assessment of Aromatic Wentong for Coronary Microvascular Disease Management

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 30, 2025
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.