This clinical trial aims to evaluate the efficacy and safety of Yangxin Dawayimixike Honey Paste in intervening carotid atherosclerotic plaque combined with dyslipidemia. The study will enroll patients with carotid atherosclerotic plaque and dyslipidemia in a multicenter, randomized, double-blind, placebo-controlled trial. Based on standardized Western medical treatment, the treatment group will receive Yangxin Dawayimixike Honey Paste, while the control group will receive a simulated preparation of Yangxin Dawayimixike Honey Paste. The treatment duration is 12 months, followed by a one-year follow-up period. The primary efficacy endpoint is the change in intima-media thickness (IMT) of the carotid artery. Secondary efficacy endpoints include plaque Crouse score, plaque area, vascular remodeling index (RI), major adverse cardiovascular events (MACE), four lipid parameters (total cholesterol, triglycerides, LDL-C, HDL-C), Traditional Chinese Medicine syndrome score, and quality of life scale (SF-36). Safety indicators include vital signs (respiration, pulse, heart rate, blood pressure), complete blood count, routine urinalysis, routine stool examination, liver and kidney function tests, and four coagulation parameters. These measures will be used to assess the treatment's efficacy and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
422
3 g bid po
3 g bid po
carotid intima-media thickness
Time frame: 12 months
Plaque Crouse Score
Time frame: 12 months
plaque area
Time frame: 12 months
RI (Vascular Remodeling Index)
Time frame: 12 months
MACE (Major Adverse Cardiovascular Events)
Time frame: 12 months
total cholesterol, triglycerides, LDL-C, HDL-C
Time frame: 12 months
Traditional Chinese Medicine syndrome score
Time frame: 12 months
36-Item Short Form Health Survey
Time frame: 12 months
24-item Hamilton Depression Rating Scale
Time frame: 12 months
14-item Hamilton Anxiety Rating Scale
Time frame: 12 months
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