NCT06901570

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

Clinical Assessment of Aromatic Wentong for Coronary Microvascular Disease Management

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 528 (estimated)
• Sponsor: China-Japan Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-04-01
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2025-03-30
• Last updated: 2025-04-11

Locations

1 site across 1 country: China