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

NCT ID: NCT07314775

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 422 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2029-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Yangxin Dawayimixike Honey Paste placebo

Intervention Type: DRUG

3 g bid po

Yangxin Dawayimixike Honey Paste

Group Type: EXPERIMENTAL

Yangxin Dawayimixike Honey Paste

Intervention Type: DRUG

3 g bid po

Interventions

Yangxin Dawayimixike Honey Paste

3 g bid po

Intervention Type: DRUG

Yangxin Dawayimixike Honey Paste placebo

3 g bid po

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Meets the diagnostic criteria for Carotid Atherosclerotic Plaque (CAP);

2. Meets the diagnostic criteria for dyslipidemia;

3. Meets the TCM syndrome differentiation criteria for Qi Stagnation and Blood Stasis pattern;

4. Aged 18-75 years, both sexes eligible;

5. Vital signs stable, conscious with normal communication ability;

6. Subject voluntarily participates and signs the informed consent form.

Exclusion Criteria

1. 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;

2. 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;

3. 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;

4. Patients with severe psychological disorders, intellectual disabilities, or language barriers;

5. Pregnant or lactating women;

6. Patients with known hypersensitivity to the investigational drug;

7. Patients concurrently participating in other clinical trials.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinjiang Uygur Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sun Longfei Sun Longfei, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital

Central Contacts

Sun Longfei Sun Longfei, Ph.D.

Role: CONTACT

578128270@qq.com

86+15276617857

Other Identifiers

2024ZD0528302

Identifier Type: -

Identifier Source: org_study_id