DyslipidemiaPhase 4NCT07314775
Yangxin Dawayimixike Honey Paste for Carotid Atherosclerotic Plaque With Dyslipidemia: A Randomized Controlled Clinical Study
A Phase 4 study testing Yangxin Dawayimixike Honey Paste in people with Dyslipidemia and Carotid Atherosclerotic Plaques, run by Xinjiang Uygur Pharmaceutical Co., Ltd..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dyslipidemia, Carotid Atherosclerotic Plaques
- What is being tested?
- Yangxin Dawayimixike Honey Paste
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 422 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Jan 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this 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.
- Conditions
- Dyslipidemia, Carotid Atherosclerotic Plaques
- Being tested
- Yangxin Dawayimixike Honey Paste, Yangxin Dawayimixike Honey Paste placebo
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yangxin Dawayimixike Honey PasteDrug
3 g bid po
Yangxin Dawayimixike Honey Paste placeboDrug
3 g bid po
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Yangxin Dawayimixike Honey Paste placebo |
| Yangxin Dawayimixike Honey Paste | Experimental | Not described Receives: Drug: Yangxin Dawayimixike Honey Paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
carotid intima-media thickness
Measured: 12 months
Secondary outcomes (9)
Plaque Crouse Score
Measured: 12 months
plaque area
Measured: 12 months
RI (Vascular Remodeling Index)
Measured: 12 months
MACE (Major Adverse Cardiovascular Events)
Measured: 12 months
total cholesterol, triglycerides, LDL-C, HDL-C
Measured: 12 months
Traditional Chinese Medicine syndrome score
Measured: 12 months
36-Item Short Form Health Survey
Measured: 12 months
24-item Hamilton Depression Rating Scale
Measured: 12 months
14-item Hamilton Anxiety Rating Scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 422 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinjiang Uygur Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sun Longfei Sun Longfei, Ph.D., Principal investigator, Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314775
- Sponsor's protocol ID
- 2024ZD0528302
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yangxin Dawayimixike Honey Paste for Carotid Atherosclerotic Plaque With Dyslipidemia: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07314775
- Acronym / sponsor ID
- 2024ZD0528302
- Conditions
- Dyslipidemia, Carotid Atherosclerotic Plaques
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 422 participants (estimated)
- Lead sponsor
- Xinjiang Uygur Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Yangxin Dawayimixike Honey Paste placebo |
| Yangxin Dawayimixike Honey Paste | Experimental | Drug: Yangxin Dawayimixike Honey Paste |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yangxin Dawayimixike Honey Paste3 g bid po | Drug | Yangxin Dawayimixike Honey Paste |
| Yangxin Dawayimixike Honey Paste placebo3 g bid po | Drug | Placebo |
Primary outcome
carotid intima-media thickness
Time frame: 12 months
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sun Longfei Sun Longfei, Ph.D. principal investigator
Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Yangxin Dawayimixike Honey Paste in people with Dyslipidemia and Carotid Atherosclerotic Plaques, run by Xinjiang Uygur Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sun Longfei Sun Longfei, Ph.D. (86+15276617857, 578128270@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
carotid intima-media thickness (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.