A Randomized Double-Blind, Placebo-Controlled, Multicenter Clinical Study on the Efficacy and Safety of Yangxin Dawayimixike Miga in the Treatment of Coronary Atherosclerosis (Qi Stagnation and Blood Stasis Syndrome)

Randomized Double-blind, Placebo-controlled, Multicenter Clinical Study on the Efficacy and Safety of Yangxin Dawayimixike Miga for the Treatment of Coronary Artery Atherosclerosis (Qi Stagnation and Blood Stasis Syndrome) in the Integrated Traditional Chinese and Western Medicine Clinical Collaboration Project for Major and Difficult Diseases

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2026000198

Enrollment

Unknown

Registered

2026-01-28

Start date

2026-03-01

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary atherosclerosis

Interventions

experimental group:Atorvastatin Calcium Tablets + Yangxin Davayi Mixike Mi Ointment, 3g each time, 2 times a day, taken orally

control group:Atorvastatin Calcium Tablets (Lipitor), 10mg, oral administration, once a day

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Coronary angiography or coronary CTA examination reveals that at least one coronary artery has a lesion <70% and =20%; 2.Meets the diagnostic criteria for the syndrome of qi stagnation and blood stasis in traditional Chinese medicine; 3.Aged =18 years and =75 years, regardless of gender;

Exclusion criteria

Exclusion criteria: 1.Patients with heart failure who have New York Heart Association (NYHA) class IV heart function or a left ventricular ejection fraction = 40%; 2.Patients who have received or need to receive coronary stent implantation; 3.Patients with multi-vessel disease who require coronary artery bypass grafting; 4.Patients with contraindications to coronary CTA examination; 5.Patients with severe arrhythmias (including severe atrioventricular block, ventricular tachycardia, atrial fibrillation, etc.); 6.Patients with mental disorders who cannot cooperate with treatment independently; 7.Patients with malignant tumors or complicated with acute infections, trauma, or active rheumatic diseases; 8.Pregnant or lactating women, or women planning to become pregnant;

Design outcomes

Primary

Measure	Time frame
Changes in low-attenuation plaque volume after 24 weeks of treatment;	—

Secondary

Measure	Time frame
Total Patch Volume Change Value;Changes in low-attenuation plaque burden value;Changes in total plaque burden value;TC TG LDL-C HDL-C;Traditional Chinese Medicine Syndrome Score;ET-1 NO;hsCRP TNF-a IL-6;	—

Countries

China

Contacts

Public ContactAn Dongqing

Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine

326468701@qq.com18099678099

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 7, 2026