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

NCT06901570 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 528

Last updated 2025-04-11

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • China-Japan Friendship Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2028-07-31
Completion
2028-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06901570 on ClinicalTrials.gov