Study on Vulnerable Plaque of Carotid Artery With Chinese Herbal and Insects Medicine

Study Overview
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Brief Summary
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The investigators want treat Vulnerable plaque of carotid artery with a herbal and insects Chinese medicine. Designing a RCT trial to prove the effect and safety.

Detailed Description
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Vulnerable plaque of carotid artery is the important intervention target for primary prevention and secondary prevention of cerebral arterial thrombosis, but there are no effective, safe and prevalent treatment measures against it. The development that traditional Chinese medicine has achieved in treating plaque of carotid artery shows that great accomplishment could be made within this area. Academia should engage in clinical research on regulated treatment methods in traditional Chinese medicine with long-term intervention and high patient compliance, providing strong evidence for evidence-based medicine and guidance to clinical practice.

Official Title
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Randomized Controlled Clinical Study on Vulnerable Plaque of Carotid Artery With Chinese Herbal and Insects Medicine

Conditions
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Carotid Artery Plaque

Intervention / Treatment
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* Drug: Herbal Medicine C-117
* Drug: The Placebo of Herbal Medicine C-117


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet the diagnostic criteria of carotid artery atherosclerosis; Ultrasound of carotid artery atherosclerosis plaque specifies it as unstable plaque (including malacoplakia and mixed plaque); Exclusion Criteria: mRS Rating higher than or equal to 3 before joining the trail group; Carotid artery stenosis is higher than or equal to 50%; Confirmed as or suspected to be vasculitis; With infection, tumor or insufficient heart, liver and kidney functions (renal function higher than twice of upper limit in normal limit, HYHA heart function grading higher than or equal to level 2 ); With acute myocardial infarction and unstable angina pectoris; With acute cerebral arterial thrombosis; lesion: Severe stenosis or occlusion of distal intracranial vessels; Pregnant women or lactating mothers; With known history of allergy to the drugs of the trial.

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Herbal Medicine C-117<br>Herbal Medicine C-117 Prescription (6g/bag，one bag each time, twice a day.) for 6 months | Drug: Herbal Medicine C-117<br>* Herbal Medicine C-117 formula including 2 herbals and 2 insects<br>|
| Placebo Comparator: The Placebo of Herbal Medicine C-117<br>Placebo of Herbal Medicine C-117 (6g/bag，one bag each time, twice a day.) for 6 months | Drug: The Placebo of Herbal Medicine C-117<br>* The Placebo of Herbal Medicine C-117 formula including 4 herbals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total number of all-cause mortality and all-cause stroke within 12 months | After drug-use 6 months, observe all-cause mortality and all-cause stroke (hemorrhage or ischemic). | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The nature of Vulnerable plaque of carotid artery through color ultrasound | At the time of 6 months, observe the nature of Vulnerable plaque of carotid artery through color ultrasound, comparing with the result before using drugs | 6 months | 
| The number of Vulnerable plaque of carotid artery through color ultrasound | At the time of 6 months, observe the nature of Vulnerable plaque of carotid artery through color ultrasound, comparing with the result before using | 6 months | 
| Blood lipid levels | At the time of 6 months, the investigators will observe the blood lipid levels | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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herbal medicine, stroke, vulnerable plaques of carotid artery