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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group | Placebo Comparator | Basic treatment according to the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack and placebo granules (6g/ bag, one bag each time, twice a day after meals); |
|
| Qushi Formula Group | Experimental | Basic treatment according to the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack and Qushi Formula granules (6g/ bag, one bag each time, twice a day after meals); |
|
| Zhu's Wenban Formula Group | Experimental | Basic treatment according to the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack and Zhu's Wenban Formula granules (6g/ bag, one bag each time, twice a day after meals); |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qushi Formula | Drug | Qushi Formula are decoction granules composed 8 traditional Chinese medicines, such as poria cocos, Macrocephalae Rhizoma, Polyporus, cassia twig, dried ginger and licorice, Etc. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of new cardiovascular events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Province Hospital of Tradtional Chinese Medicine | Guangzhou | Guangdong | 510120 | China |
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| ID | Term |
|---|---|
| D004194 | Disease |
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
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| Zhu's Wenban Formula | Drug | Zhu's Wenban granules are decoction granules composed of leech, panax notoginseng, Atractylodes Lancea and rhizome |
|
| placebo | Drug | The placebo was composed of dextrin, powdered sugar, starch, and liquid caramel in the same color as the other two groups. |
|
| Basic treatment | Other | 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. |
|
Number of cardiovascular and cerebrovascular events during 6 months of treatment and 6 months of follow-up
| 12 moths |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |