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NCT Number: NCT07314775

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Yangxin Dawayimixike Honey Paste

Drug

3 g bid po

Yangxin Dawayimixike Honey Paste placebo

Drug

3 g bid po

Primary outcomes

  1. carotid intima-media thickness

    Time frame: 12 months

Secondary outcomes

  1. Plaque Crouse Score

    Time frame: 12 months

  2. plaque area

    Time frame: 12 months

  3. RI (Vascular Remodeling Index)

    Time frame: 12 months

  4. MACE (Major Adverse Cardiovascular Events)

    Time frame: 12 months

  5. total cholesterol, triglycerides, LDL-C, HDL-C

    Time frame: 12 months

  6. Traditional Chinese Medicine syndrome score

    Time frame: 12 months

  7. 36-Item Short Form Health Survey

    Time frame: 12 months

  8. 24-item Hamilton Depression Rating Scale

    Time frame: 12 months

  9. 14-item Hamilton Anxiety Rating Scale

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Sun Longfei Sun Longfei, Ph.D.

CONTACT

[email protected]

86+15276617857

Sponsors and collaborators

Lead sponsor

Xinjiang Uygur Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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