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Not yet recruiting NCT07314775

Yangxin Dawayimixike Honey Paste for Carotid Atherosclerotic Plaque With Dyslipidemia: A Randomized Controlled Clinical Study

Phase IV Interventional Dyslipidemia Carotid Atherosclerotic Plaques

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Yangxin Dawayimixike Honey Paste, Yangxin Dawayimixike Honey Paste placebo.
Who it may be relevant to
Registry conditions: Dyslipidemia, Carotid Atherosclerotic Plaques. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Yangxin Dawayimixike Honey Paste
    3 g bid po
  • Drug Yangxin Dawayimixike Honey Paste placebo
    3 g bid po

Primary outcome measures

  • carotid intima-media thickness [Time frame: 12 months]
Secondary outcome measures (9)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07314775 · 2024ZD0528302

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗