Carotid Artery Plaque
Conditions
Keywords
herbal medicine, stroke, vulnerable plaques of carotid artery
Brief summary
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
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.
Interventions
Herbal Medicine C-117 formula including 2 herbals and 2 insects
The Placebo of Herbal Medicine C-117 formula including 4 herbals
Sponsors
Guangzhou University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The total number of all-cause mortality and all-cause stroke within 12 months | 1 years | After drug-use 6 months, observe all-cause mortality and all-cause stroke (hemorrhage or ischemic). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The nature of Vulnerable plaque of carotid artery through color ultrasound | 6 months | 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 |
| The number of Vulnerable plaque of carotid artery through color ultrasound | 6 months | At the time of 6 months, observe the nature of Vulnerable plaque of carotid artery through color ultrasound, comparing with the result before using |
| Blood lipid levels | 6 months | At the time of 6 months, the investigators will observe the blood lipid levels |
Contacts
Primary ContactJianwen Guo, Bachelor
Outcome results
None listed