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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dyslipidemia; Carotid Atherosclerotic Plaques
• Intervention / Treatment: Drug: Yangxin Dawayimixike Honey Paste placebo; Drug: Yangxin Dawayimixike Honey Paste

• Study Type: Interventional
• Enrollment (Estimated): 422
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sun Longfei Sun Longfei, Ph.D.; Phone Number: 86+15276617857; Email: 578128270@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Yangxin Dawayimixike Honey Paste placebo; 3 g bid po
Experimental: Yangxin Dawayimixike Honey Paste	Drug: Yangxin Dawayimixike Honey Paste; 3 g bid po

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
carotid intima-media thickness	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Xinjiang Uygur Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Sun Longfei Sun Longfei, Ph.D., Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Dyslipidemias
• Other Study ID Numbers: 2024ZD0528302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No