The Proteomic Study and Early Intervention Study of Carotid Unstable Plaque

Study Overview
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Brief Summary
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A study on the prediction model of carotid unstable plaque protein and its early intervention. Protein antibody chip was used to detect the remaining biological samples, and patients with carotid artery unstable plaque with stroke risk were selected for interventional clinical trials. The selected patients were randomly divided into 3 groups, which were treated with Zhu's Wenban Formula (TCM compound granules), Qushi Formula (TCM compound granules) and placebo for 6 months, respectively. The size and number of carotid artery unstable plaques before and after 6 months were observed, and the occurrence of adverse reactions during the intervention period was observed.

Official Title
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The Proteomic Study and Early Intervention Study of Carotid Unstable Plaque

Conditions
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Protein; Disease, Carotid Artery Plaque, Traditional Chinese Medicine

Intervention / Treatment
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* Drug: Qushi Formula
* Drug: Zhu's Wenban Formula
* Drug: placebo
* Other: Basic treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Wet syndrome scale assessment is consistent with wet syndrome diagnosis; Carotid color ultrasound indicated carotid artery unstable plaque. Protein chip analysis determined that the patients were at high risk of stroke Signing informed Consent Exclusion Criteria: Carotid artery stenosis rate ≥50%; A definite or suspected diagnosis of vasculitis; Accompanied by infection, tumor, heart, liver and renal insufficiency (liver and kidney function more than twice the upper limit of normal value, cardiac function grade greater than or equal to 2); Patients with acute stroke or complicated with acute myocardial infarction and unstable angina pectoris; Pregnant or lactating women; A prior known allergy to the test drug or the test drug ingredient.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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 |
| --- | --- |
| Placebo Comparator: Placebo Group<br>Basic treatment according to the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack and placebo granules (6g/ bag, one bag each time, twice a day after meals); | Drug: placebo<br>* The placebo was composed of dextrin, powdered sugar, starch, and liquid caramel in the same color as the other two groups.<br>Other: Basic treatment<br>* Basic diseases except hyperlipidemia were treated in accordance with the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack. Basic treatment includes conventional treatment such as comprehensive prevention and treatment (actively controlling basic diseases such as hypertension and diabetes and suggesting a good lifestyle), drug therapy (anti-inflammatory, lipid-regulating, anti-platelet aggregation, calcium channel blockers) and so on according to individual conditions of patients.<br>|
| Experimental: Qushi Formula Group<br>Basic treatment according to the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack and Qushi Formula granules (6g/ bag, one bag each time, twice a day after meals); | Drug: Qushi Formula<br>* Qushi Formula are decoction granules composed 8 traditional Chinese medicines, such as poria cocos, Macrocephalae Rhizoma, Polyporus, cassia twig, dried ginger and licorice, Etc.<br>Other: Basic treatment<br>* Basic diseases except hyperlipidemia were treated in accordance with the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack. Basic treatment includes conventional treatment such as comprehensive prevention and treatment (actively controlling basic diseases such as hypertension and diabetes and suggesting a good lifestyle), drug therapy (anti-inflammatory, lipid-regulating, anti-platelet aggregation, calcium channel blockers) and so on according to individual conditions of patients.<br>|
| Experimental: Zhu's Wenban Formula Group<br>Basic treatment according to the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack and Zhu's Wenban Formula granules (6g/ bag, one bag each time, twice a day after meals); | Drug: Zhu's Wenban Formula<br>* Zhu's Wenban granules are decoction granules composed of leech, panax notoginseng, Atractylodes Lancea and rhizome<br>Other: Basic treatment<br>* Basic diseases except hyperlipidemia were treated in accordance with the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack. Basic treatment includes conventional treatment such as comprehensive prevention and treatment (actively controlling basic diseases such as hypertension and diabetes and suggesting a good lifestyle), drug therapy (anti-inflammatory, lipid-regulating, anti-platelet aggregation, calcium channel blockers) and so on according to individual conditions of patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in carotid artery unstable plaque | Changes in carotid IMT and the total volume and number of unstable plaques before and after 6 months of treatment | 6 moths | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in blood lipids | The changes of triglyceride, total cholesterol, low density lipoprotein and high density lipoprotein before and after 6 months of treatment; | 6 moths | 
| Number of new cardiovascular events | Number of cardiovascular and cerebrovascular events during 6 months of treatment and 6 months of follow-up | 12 moths | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traditional Chinese Medicine, proteomic study, carotid atherosclerosis plaques