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A Double-Blind, Randomized, Controlled Study on the Effect of Guizhi Tongluo Tablets on Carotid Plaque Vulnerability in Subclinical Atherosclerosis Population Using Multimodal Ultrasound Evaluation

A Double-Blind, Randomized, Controlled Study on the Effect of Guizhi Tongluo Tablets on Carotid Plaque Vulnerability in Subclinical Atherosclerosis Population Using Multimodal Ultrasound Evaluation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000717
Enrollment
Unknown
Registered
2026-03-24
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Subclinical atherosclerosis

Interventions

Experimental group:Guizhi Tongluo tablets
Control group:Guizhi Tongluo tablets placebo

Sponsors

Shenzhen Hospital of Integrated Traditional Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Meet the diagnostic criteria for carotid atherosclerosis 2.Aged 35 years = Age < 65years 3.Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1.History of cardiovascular disease (including myocardial infarction, or treatment with percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]); 2.Have a history of stroke (including atherosclerotic cerebral infarction or hemorrhagic stroke, but lacunar infarction and transient ischemic attack [TIA] are not excluded); 3.Diseases of secondary hypertension, including renal parenchymal or renal vascular diseases, primary aldosteronism, pheochromocytoma, hyperthyroidism, etc; However, the patient has no clinical signs or symptoms in one or more arterial regions or atherosclerosis diseases that can be attributed to the clinical manifestations in this region, such as angina, stroke, limb pain, etc; 4.Severe liver, kidney and other organ dysfunction (ALT = 3 times the upper limit of normal); Subjects undergoing dialysis treatment; Or blood creatinine>2.5 mg/dl [>221 mol/L]; 5.Severe acute or chronic infections, immune system diseases, hematopoietic or coagulation dysfunction; Merge other serious illnesses and have an expected life expectancy of less than 12 months; 6.Pregnancy or breastfeeding; 7.Participants in other clinical research trials.

Design outcomes

Primary

MeasureTime frame
Plaque neovascularization score;

Secondary

MeasureTime frame
Carotid intima-media thickness;Size and area of carotid plaque;Echoes of carotid plaques;Chinese Medicine Blood Stasis Syndrome Efficacy Score;Quality of Life and Sleep Quality;Biochemical indicators of cardiovascular risk factors;Number of plaques;Carotid artery stenosis and severity assessment;Carotid artery blood flow velocity (PSV);plaque morphology;Baseline indicators;

Countries

The People's Republic of China

Contacts

Public ContactHaibing Rao

Shenzhen Hospital of Integrated Traditional Chinese and Western Medicine

651856580@qq.com13823129621

Outcome results

None listed

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