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

NCT06901570 | Not Yet Recruiting Phase 4

• 1 other identifier: 2023ZD0505705
• Study Type: interventional
• Target: 528
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Score of the Traditional Chinese Medicine Syndrome Score Scale

  Baseline, 4 weeks, and 8 weeks.

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

  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

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Drug: Kuangxiong Aerosol

Control Arm

PLACEBO COMPARATOR

Drug: Placebo Drug

Interventions

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.

Experimental Arm

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.

Control Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Chaoyang District, 100029, China

Location

MeSH Terms

Conditions

Microvascular Angina

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Xianlun Li

CONTACT

13910812495; lixianlun@hotmail.com

Danni Wu

CONTACT

13502622048; wudanni@student.pumc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 30, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)