A Phase 1 interventional study of Qushi Formula and Zhu's Wenban Formula in Protein; Disease, Carotid Artery Plaque and Traditional Chinese Medicine, sponsored by Guangzhou University of Traditional Chinese Medicine. Status unknown at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-03-14.
Sponsored by Guangzhou University of Traditional Chinese Medicine · Phase 1, Interventional, and Treatment
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.
1,385 studies on the registry are indexed under Disease; 612 are open to participants now.
This study's planned enrollment of 300 is above the median of 80 across 762 interventional studies indexed under Disease.
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Exclusion Criteria:
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);
Drug: placebo · Other: Basic treatment
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);
Drug: Qushi Formula · Other: Basic treatment
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);
Drug: Zhu's Wenban Formula · Other: Basic treatment
Qushi Formula are decoction granules composed 8 traditional Chinese medicines, such as poria cocos, Macrocephalae Rhizoma, Polyporus, cassia twig, dried ginger and licorice, Etc.
Zhu's Wenban granules are decoction granules composed of leech, panax notoginseng, Atractylodes Lancea and rhizome
The placebo was composed of dextrin, powdered sugar, starch, and liquid caramel in the same color as the other two groups.
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.
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
Time frame: 6 moths
Changes in blood lipids
The changes of triglyceride, total cholesterol, low density lipoprotein and high density lipoprotein before and after 6 months of treatment;
Time frame: 6 moths
Number of new cardiovascular events
Number of cardiovascular and cerebrovascular events during 6 months of treatment and 6 months of follow-up
Time frame: 12 moths
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Guangzhou University of Traditional Chinese Medicine