Multi-center evidence-based clinical evaluation of Lingbao Huxin Dan in the treatment of carotid plaque

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2025000929

Enrollment

Unknown

Registered

2025-05-08

Start date

2024-10-01

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

Carotid plaque

Interventions

Experimental Group:Patients will receive standard Western medicine treatment + Lingbao Huxin Dan.

Control Group:Patients will receive standard Western medicine treatment which includes either Atorvastatin Calcium Tablets + Enteric-Coated Aspirin Tablets or Rosuvastatin Calcium Tablets + Enteric-Co

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria (1) Age between 18 to 80 years old with no gender restrictions. (2) Meets the Western medicine diagnostic criteria for carotid plaques: Presence of carotid plaques confirmed by carotid ultrasound with carotid intima-media thickness (CIMT) = 1.5 mm indicating plaque formation; the severity of the plaque does not meet the criteria for surgical intervention. (3) Low-density lipoprotein cholesterol (LDL-C) level > 2.6 mmol/L and < 4.1 mmol/L. (4) Voluntarily signs the informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion Criteria (1) Age 80 years. (2) Does not meet the Western medicine diagnostic criteria for carotid plaques. (3) Low-density lipoprotein cholesterol (LDL-C) level = 2.6 mmol/L or = 4.1 mmol/L. (4) Carotid artery stenosis > 50% history of cardiovascular or cerebrovascular diseases or major surgery within the past six months. (5) Comorbidities including malignant hypertension severe arrhythmia severe cardiopulmonary dysfunction or severe hepatic and renal insufficiency. (6) Pregnant or lactating women. (7) Allergy to any known components of the study medications. (8) Patients unable to cooperate with observation due to mental disorders cognitive impairment or other psychiatric illnesses. (9) Poor compliance or any other condition deemed unsuitable for participation by the researchers.

Design outcomes

Primary

Measure	Time frame
Carotid intimedia thickness;Crouse patch score;	—

Secondary

Measure	Time frame
Therapeutic effectiveness;Total carotid plaque count;Maximum area of carotid plaque;Lipid level;	—

Countries

China

Contacts

Public ContactZeng Hesong

Tongji Hospital Tongji Medical College of HUST

zenghs@tjh.tjmu.edu.cn027-83663200

Outcome results

None listed

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