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A multicenter randomized controlled trial evaluating the efficacy of HuazhuoTiaozhi Granules in delaying the progression of carotid atherosclerotic plaques

A multicenter randomized controlled trial evaluating the efficacy of HuazhuoTiaozhi Granules in delaying the progression of carotid atherosclerotic plaques

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002174
Enrollment
Unknown
Registered
2025-11-08
Start date
2025-12-01
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

Interventions

Yunpi Huazhuo group:Huazhuo Tiaozhi Granules+Atorvastatin
Control group:Huazhuo Tiaozhi Granules Placebo+Atorvastatin

Sponsors

Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age 30 to 65 years old; (2) Meets the diagnostic criteria for carotid atherosclerotic plaques based on ultrasound examination ; (3) Meets the diagnostic criteria for intermingled phlegm-stasis blood syndrome according to traditional Chinese medicine; (4) Those who signed the Informed Consent Form and voluntarily participated in this study.

Exclusion criteria

Exclusion criteria: (1) Patients in the acute phase of cardiovascular and cerebrovascular diseases; (2) Patients with a history of cerebral hemorrhage; (3) Patients with active liver disease, or those with persistently elevated serum transaminase levels of unknown cause, or those with ALT levels at or above the upper limit of the normal reference range; (4) Patients with severe renal dysfunction; (5) Patients with concomitant severe primary diseases such as respiratory, hematological disorders, or malignant tumors; (6) Pregnant women, lactating women, or women of childbearing age with a desire to conceive; (7) Patients with neurological or psychiatric disorders who are unable or unwilling to cooperate; (8) Patients with allergies to drug components or a history of allergic reactions; (9) Patients with poor compliance who cannot attend regular follow-up visits; (10) Patients who have participated in other clinical studies within the past month; (11) Patients with active ulcers or a tendency to bleed, or those who have been taking anticoagulant drugs (such as warfarin) long-term; (12) Asymptomatic patients with ultrasound findings showing plaque-induced carotid artery lumen stenosis =70%, severely impairing carotid artery blood flow; (13) Patients with symptoms showing plaque-induced carotid artery lumen stenosis =50%; (14) Patients with severe arrhythmias, atrial fibrillation, or heart failure; (15) Patients currently using dual antiplatelet therapy; (16) Patients who have previously undergone carotid artery plaque excision or carotid artery stenting.

Design outcomes

Primary

MeasureTime frame
Average change in carotid intima-media thickness;

Secondary

MeasureTime frame
Total carotid atherosclerotic plaque area;area of necrotic core;Carotid Atherosclerotic Plaque Efficacy Evaluation Scale;TC;TG;LDL-C;HDL-C;Incidence of Major Adverse Cardiovascular and Cerebrovascular Events;

Countries

China

Contacts

Public ContactHe Qingyong

Guang'anmen Hospital,China Academy of Chinese Medical Sciences

heqingyongg@163.com+86 135 8196 5248

Outcome results

None listed

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