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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Yangxin Dawayimixike Honey Paste | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yangxin Dawayimixike Honey Paste | Drug | 3 g bid po |
| |
| Measure | Description | Time Frame |
|---|---|---|
| carotid intima-media thickness | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque Crouse Score | 12 months | |
| plaque area | 12 months | |
| RI (Vascular Remodeling Index) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sun Longfei Sun Longfei, Ph.D. | Contact | 86+15276617857 | 578128270@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Sun Longfei Sun Longfei, Ph.D. | Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital | Principal Investigator |
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| Yangxin Dawayimixike Honey Paste placebo |
| Drug |
3 g bid po |
|
| 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 |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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