The Proteomic Study and Early Intervention Study of Carotid Unstable Plaque

Phase 1

Not yet recruiting

• Conditions: Carotid Artery Plaque; Protein; Disease; Traditional Chinese Medicine
• Interventions: Drug: placebo; Drug: Qushi Formula; Drug: Zhu's Wenban Formula; Other: Basic treatment

• Registration Number: NCT05622877
• Lead Sponsor: Guangzhou University of Traditional Chinese Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2022-11-14
• Study First Posted: 2022-11-21
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-14
• Study Start: 2023-05-31
• Primary Completion: 2024-01-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	placebo	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);
Placebo Group	Basic treatment	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	Qushi Formula	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);
Qushi Formula Group	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);
Zhu's Wenban Formula Group	Zhu's Wenban Formula	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);
Zhu's Wenban Formula Group	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);

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Guangdong Province Hospital of Tradtional Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China