Spchim: Study on Vulnerable Plaque of Carotid Artery With Chinese Herbal and Insects Medicine
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Herbal Medicine C-117 Herbal Medicine C-117 Prescription (6g/bag，one bag each time, twice a day.) for 6 months |
Drug: Herbal Medicine C-117
Herbal Medicine C-117 formula including 2 herbals and 2 insects
|
| Placebo Comparator: The Placebo of Herbal Medicine C-117 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
The Placebo of Herbal Medicine C-117 formula including 4 herbals
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
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;
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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 );
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With acute myocardial infarction and unstable angina pectoris;
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With acute cerebral arterial thrombosis;
-
lesion: Severe stenosis or occlusion of distal intracranial vessels;
-
Pregnant women or lactating mothers;
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With known history of allergy to the drugs of the trial.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Guangzhou University of Traditional Chinese Medicine
Investigators
- Principal Investigator: Jianwen Guo, MD, Guangdong Province Hospital of Tradtional Chinese Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- YN2014LN08