NCT05622877

The Proteomic Study and Early Intervention Study of Carotid Unstable Plaque

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Guangzhou University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Protein; Disease
• Carotid Artery Plaque
• Traditional Chinese Medicine

Interventions

Type	Name	Description
DRUG	Qushi 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.
DRUG	Zhu's Wenban Formula	Zhu's Wenban granules are decoction granules composed of leech, panax notoginseng, Atractylodes Lancea and rhizome
DRUG	placebo	The placebo was composed of dextrin, powdered sugar, starch, and liquid caramel in the same color as the other two groups.
OTHER	Basic 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.

Timeline

• Start date: 2023-05-31
• Primary completion: 2024-01-31
• Completion: 2024-12-31
• First posted: 2022-11-21
• Last updated: 2023-03-14

Locations

1 site across 1 country: China