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Huoxue Wentong Formula in the Treatment of Carotid Atherosclerotic Plaque with Coronary Heart Disease: A Randomized Controlled Trial

Evidence-Based Research on Optimal TCM Strategies for Delaying the Progression of Carotid Atherosclerotic Plaque-Huoxue Wentong Formula in the Treatment of Carotid Atherosclerotic Plaque with Coronary Heart Disease: A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001941
Enrollment
Unknown
Registered
2025-10-15
Start date
2025-03-27
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Carotid Atherosclerotic Plaque with Coronary Heart Disease

Interventions

Treatment Group:Huoxue Wentong Formula Granules + Conventional Western Medicine Therapy
Control Group :Placebo of Huoxue Wentong Formula Granules + Conventional Western Medicine Therapy

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medicine Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for carotid atherosclerotic plaque; (2) Meet the diagnostic criteria for stable coronary heart disease, with angina pectoris classified as Class I–II; (3) Conform to the Traditional Chinese Medicine (TCM) pattern diagnosis of Yang deficiency and blood stasis; (4) Aged 18–75 years, both male and female; (5) Stable vital signs, clear consciousness, and normal communication ability; (6) Voluntary participation with signed informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with severe cardiovascular diseases, including acute myocardial infarction, unstable angina pectoris, NYHA Class = III, severe arrhythmia, congenital heart disease, or severe valvular heart disease; (2) Poorly controlled hypertension (systolic blood pressure [SBP] = 180 mmHg or diastolic blood pressure [DBP] = 100 mmHg); severe cerebrovascular diseases; hemorrhagic or hematopoietic system diseases; malignant tumors, etc.; (3) Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels exceeding 2 times the upper limit of normal; renal dysfunction (defined as serum creatinine level > 1.5 times the upper limit of normal); (4) Severe psychological, intellectual, or language impairment; (5) Pregnant or lactating women; (6) Known allergy to the investigational drug; (7) Concurrent participation in another clinical study.

Design outcomes

Primary

MeasureTime frame
Carotid Intima-Media Thickness;

Secondary

MeasureTime frame
Plaque Crouse Score;Plaque Area;Vascular Remodelling Index;Major Adverse Cardiovascular Events;Computed Tomography Fractional Flow Reserve ; Coronary Artery Calcium Score;Degree of Coronary Artery Stenosis;Echocardiography;Lipid Profile;Traditional Chinese Medicine Syndrome Score;Seattle Angina Questionnaire;36-Item Short Form Health Survey;Hamilton Depression Rating Scale (24-Item);Hamilton Anxiety Rating Scale (14-Item);

Countries

China

Contacts

Public ContactYao Kuiwu

Guang'anmen Hospital of China Academy of Chinese Medicine Sciences

yaokuiwu@126.com18610366611

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026