Carotid Artery Plaque Clinical Trial
— SpchimOfficial title:
Randomized Controlled Clinical Study on Vulnerable Plaque of Carotid Artery With Chinese Herbal and Insects Medicine
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.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | December 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Meet the diagnostic criteria of carotid artery atherosclerosis; 2. Ultrasound of carotid artery atherosclerosis plaque specifies it as unstable plaque (including malacoplakia and mixed plaque); Exclusion Criteria: 1. mRS Rating higher than or equal to 3 before joining the trail group; 2. Carotid artery stenosis is higher than or equal to 50%; 3. Confirmed as or suspected to be vasculitis; 4. 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 ); 5. With acute myocardial infarction and unstable angina pectoris; 6. With acute cerebral arterial thrombosis; 7. lesion: Severe stenosis or occlusion of distal intracranial vessels; 8. Pregnant women or lactating mothers; 9. With known history of allergy to the drugs of the trial. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Guangzhou University of Traditional Chinese Medicine |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Blood lipid levels | At the time of 6 months, the investigators will observe the blood lipid levels | 6 months |
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