Yangxin Dawayimixike Honey Paste for Carotid Atherosclerotic Plaque With Dyslipidemia: A Randomized Controlled Clinical Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 422
- Primary Endpoint
- carotid intima-media thickness
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Meets the diagnostic criteria for Carotid Atherosclerotic Plaque (CAP);
- •Meets the diagnostic criteria for dyslipidemia;
- •Meets the TCM syndrome differentiation criteria for Qi Stagnation and Blood Stasis pattern;
- •Aged 18-75 years, both sexes eligible;
- •Vital signs stable, conscious with normal communication ability;
- •Subject voluntarily participates and signs the informed consent form.
Exclusion Criteria
- •Patients with severe cardiovascular diseases, including acute myocardial infarction, unstable angina, NYHA Class II-IV heart failure, severe arrhythmias, congenital heart disease, or severe valvular heart disease;
- •Patients with poorly controlled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure >100 mmHg), severe cerebrovascular diseases, hemorrhagic or hematologic disorders, or malignant tumors;
- •Patients with hepatic dysfunction, defined as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels exceeding twice the upper limit of normal, or renal insufficiency, defined as serum creatinine levels exceeding 1.5 times the upper limit of normal;
- •Patients with severe psychological disorders, intellectual disabilities, or language barriers;
- •Pregnant or lactating women;
- •Patients with known hypersensitivity to the investigational drug;
- •Patients concurrently participating in other clinical trials.
Arms & Interventions
Placebo
Intervention: Yangxin Dawayimixike Honey Paste placebo (Drug)
Yangxin Dawayimixike Honey Paste
Intervention: Yangxin Dawayimixike Honey Paste (Drug)
Outcomes
Primary Outcomes
carotid intima-media thickness
Time Frame: 12 months
Secondary Outcomes
- Plaque Crouse Score(12 months)
- plaque area(12 months)
- RI (Vascular Remodeling Index)(12 months)
- MACE (Major Adverse Cardiovascular Events)(12 months)
- total cholesterol, triglycerides, LDL-C, HDL-C(12 months)
- Traditional Chinese Medicine syndrome score(12 months)
- 36-Item Short Form Health Survey(12 months)
- 24-item Hamilton Depression Rating Scale(12 months)
- 14-item Hamilton Anxiety Rating Scale(12 months)