Carotid Artery Plaque Clinical Trial
Official title:
The Proteomic Study and Early Intervention Study of Carotid Unstable Plaque
Verified date | March 2023 |
Source | Guangzhou University of Traditional Chinese Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | December 31, 2024 |
Est. primary completion date | January 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Guangdong Province Hospital of Tradtional Chinese Medicine | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Guangzhou University of Traditional Chinese Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Number of new cardiovascular events | Number of cardiovascular and cerebrovascular events during 6 months of treatment and 6 months of follow-up | 12 moths |
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