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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.
Details
| Lead sponsor | China-Japan Friendship Hospital |
|---|---|
| Phase | Phase 4 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 528 |
| Start date | 2025-04 |
| Completion | 2028-07 |
Conditions
- Coronary Microvascular Disease
Interventions
- Kuangxiong Aerosol
- Placebo Drug
Primary outcomes
- Score of the Seattle Angina Questionnaire — 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.
Countries
China