The Proteomic Study and Early Intervention Study of Carotid Unstable Plaque

March 13, 2023 updated by: jianwen guo, MD, Guangzhou University of Traditional Chinese Medicine

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Guangdong Province Hospital of Tradtional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Group
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
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.
Experimental: Qushi Formula Group
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);
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.
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.
Experimental: Zhu's Wenban Formula Group
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);
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.
Drug: Zhu's Wenban Formula
Zhu's Wenban granules are decoction granules composed of leech, panax notoginseng, Atractylodes Lancea and rhizome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in carotid artery unstable plaque
Time Frame: 6 moths
Changes in carotid IMT and the total volume and number of unstable plaques before and after 6 months of treatment
6 moths

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in blood lipids
Time Frame: 6 moths
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
Time Frame: 12 moths
Number of cardiovascular and cerebrovascular events during 6 months of treatment and 6 months of follow-up
12 moths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 31, 2023

Primary Completion (Anticipated)

January 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

November 14, 2022

First Submitted That Met QC Criteria

November 14, 2022

First Posted (Actual)

November 21, 2022

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SZ2021ZZ3205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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