Carotid Artery Plaque, Protein; Disease, Traditional Chinese Medicine
Conditions
Keywords
Traditional Chinese Medicine, proteomic study, carotid atherosclerosis plaques
Brief summary
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.
Interventions
DRUGQushi Formula
Qushi Formula are decoction granules composed 8 traditional Chinese medicines, such as poria cocos, Macrocephalae Rhizoma, Polyporus, cassia twig, dried ginger and licorice, Etc.
DRUGZhu's Wenban Formula
Zhu's Wenban granules are decoction granules composed of leech, panax notoginseng, Atractylodes Lancea and rhizome
DRUGplacebo
The placebo was composed of dextrin, powdered sugar, starch, and liquid caramel in the same color as the other two groups.
OTHERBasic treatment
Basic diseases except hyperlipidemia were treated in accordance with the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack. Basic treatment includes conventional treatment such as comprehensive prevention and treatment (actively controlling basic diseases such as hypertension and diabetes and suggesting a good lifestyle), drug therapy (anti-inflammatory, lipid-regulating, anti-platelet aggregation, calcium channel blockers) and so on according to individual conditions of patients.
Sponsors
Guangzhou University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in carotid artery unstable plaque | 6 moths | Changes in carotid IMT and the total volume and number of unstable plaques before and after 6 months of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in blood lipids | 6 moths | The changes of triglyceride, total cholesterol, low density lipoprotein and high density lipoprotein before and after 6 months of treatment; |
| Number of new cardiovascular events | 12 moths | Number of cardiovascular and cerebrovascular events during 6 months of treatment and 6 months of follow-up |
Countries
China
Outcome results
None listed