Study on Hyperlipidemia Combined With Carotid Atherosclerosis With ShenJu Granules

Study Overview
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Brief Summary
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This study focuses on PWV as the main outcome, aiming to evaluate the efficacy and safety of ShenJu in treating patients with hyperlipidemia combined with carotid atherosclerosis, and provide a basis for traditional Chinese medicine treatment of hyperlipidemia combined with carotid atherosclerosis.

Detailed Description
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Hyperlipidemia is very harmful and easy to cause atherosclerosis. Atherosclerosis is the main factor of carotid atherosclerosis. Carotid atherosclerosis and plaque are usually the characteristic manifestations of atherosclerosis. Carotid arteriosclerosis is closely related to stroke, and carotid arteriosclerosis, rupture and detachment of carotid plaques, carotid stenosis and occlusion can all lead to the occurrence of cerebrovascular events. Early detection and evaluation of hyperlipidemia with carotid atherosclerosis by various means can effectively reduce the risk of cardiovascular and cerebrovascular diseases. In order to better serve the vast number of patients, Professor Wang Lei has developed ShenJu granules based on traditional Chinese medicine prescriptions and years of clinical experience. Compared to decoction, ShenJu granules have a higher concentration, are more convenient to carry, and are easy to absorb. They have received unanimous praise from patients in clinical applications.

Official Title
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A Randomized, Double-blind, Placebo-controlled Study of ShenJu in the Treatment of Hyperlipidemia Combined With Carotid Atherosclerosis

Conditions
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Hyperlipidemia, Carotid Atherosclerosis

Intervention / Treatment
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* Other: ShenJu
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient has informed consent and signed the informed consent form Age between 18-65 years old Meet the diagnostic criteria for hyperlipidemia and accompanied by carotid arteriosclerosis Meet the diagnostic criteria of TCM wet certificate: refer to the scoring standard of TCM Wet Disease Scale Exclusion Criteria: Severe liver, kidney and cardiac insufficiency Any other serious disease or condition such as: malignant tumor, uncontrolled severe hypertension, diabetic ketoacidosis (acute complication/vascular abnormality), arrhythmia, coagulation abnormalities Have participated in another clinical study within 30 days prior to enrollment or have received a history of randomized ketoacidosis in this study Pregnant women, women preparing to become pregnant and lactating women Patients who are allergic to relevant Chinese medicine ingredients Patients who have had a stent inserted Patients who the investigator determines are not suitable to participate in this study

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ShenJu<br>On the basis of standardized drug treatment for Hyperlipidemia combined with carotid atherosclerosis, participants who met the inclusion criteria were randomly given ShenJu intervention on the day of inclusion, taking it twice a day for 90 days. | Other: ShenJu<br>* One package per time, twice a day, 90 days of treatment<br>|
| Placebo Comparator: placebo<br>On the basis of standardized drug treatment for Hyperlipidemia combined with carotid atherosclerosis, participants who met the inclusion criteria were randomly given placebo granules on the day of inclusion, which were taken twice a day for 90 days (the placebo was basically the same as ShenJu in terms of appearance, shape, color, taste, etc.) | Other: Placebo<br>* One package per time, twice a day, 90 days of treatment (the placebo was basically the same as ShenJu in terms of appearance, shape, color, taste, etc.)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arm and ankle pulse wave velocity | Measures the degree of carotid artery sclerosis | At enrollment versus at day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose | blood glucose in mmol/L | At enrollment versus at day 90 | 
| Lipid indexes | Total cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein, apolipoprotein (a), free fatty acids | At enrollment versus at day 90 | 
| Indicators of carotid atherosclerosis | IMT value, IMT rate of change, common carotid peak systolic flow rate (PSV), peak diastolic flow rate (EDV), pulsatile index (PI), resistance index (RI) | At enrollment versus at day 90 | 
| TCM wet evidence | Whether it is in the population with phlegm and wetness | At enrollment versus at day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperlipidemia, Carotid arteriosclerosis, baPWV