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

NCT07314775 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2024ZD0528302
• Study Type: interventional
• Target: 422
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dyslipidemia; Carotid Atherosclerotic Plaques

Outcome Measures

Primary Outcomes (1)

• carotid intima-media thickness

  12 months

Secondary Outcomes (9)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Yangxin Dawayimixike Honey Paste placebo

Yangxin Dawayimixike Honey Paste

EXPERIMENTAL

Drug: Yangxin Dawayimixike Honey Paste

Interventions

Yangxin Dawayimixike Honey Paste DRUG

3 g bid po

Yangxin Dawayimixike Honey Paste

Yangxin Dawayimixike Honey Paste placebo DRUG

3 g bid po

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinjiang Uygur Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Sun Longfei Sun Longfei, Ph.D.

  Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sun Longfei Sun Longfei, Ph.D.

CONTACT

86+15276617857; 578128270@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: January 2, 2026

Record last verified: 2025-12