Back to resultsThe Proteomic Study and Early Intervention Study of Carotid Unstable Plaque
Primary Purpose
Protein; Disease, Carotid Artery Plaque, Traditional Chinese Medicine
Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Qushi Formula
Zhu's Wenban Formula
placebo
Basic treatment
Sponsored by
About this trial
This is an interventional treatment trial for Protein; Disease focused on measuring Traditional Chinese Medicine, proteomic study, carotid atherosclerosis plaques
Eligibility Criteria
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.
Sites / Locations
- Guangdong Province Hospital of Tradtional Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo Group
Qushi Formula Group
Zhu's Wenban Formula Group
Arm Description
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);
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);
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);
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Changes in blood lipids
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
Number of cardiovascular and cerebrovascular events during 6 months of treatment and 6 months of follow-up
Full Information
NCT ID
NCT05622877
First Posted
November 14, 2022
Last Updated
March 13, 2023
Sponsor
Guangzhou University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05622877
Brief Title
The Proteomic Study and Early Intervention Study of Carotid Unstable Plaque
Official Title
The Proteomic Study and Early Intervention Study of Carotid Unstable Plaque
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 31, 2023 (Anticipated)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Protein; Disease, Carotid Artery Plaque, Traditional Chinese Medicine
Keywords
Traditional Chinese Medicine, proteomic study, carotid atherosclerosis plaques
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
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);
Arm Title
Qushi Formula Group
Arm Type
Experimental
Arm Description
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);
Arm Title
Zhu's Wenban Formula Group
Arm Type
Experimental
Arm Description
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);
Intervention Type
Drug
Intervention Name(s)
Qushi Formula
Intervention Description
Qushi Formula are decoction granules composed 8 traditional Chinese medicines, such as poria cocos, Macrocephalae Rhizoma, Polyporus, cassia twig, dried ginger and licorice, Etc.
Intervention Type
Drug
Intervention Name(s)
Zhu's Wenban Formula
Intervention Description
Zhu's Wenban granules are decoction granules composed of leech, panax notoginseng, Atractylodes Lancea and rhizome
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
The placebo was composed of dextrin, powdered sugar, starch, and liquid caramel in the same color as the other two groups.
Intervention Type
Other
Intervention Name(s)
Basic treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in carotid artery unstable plaque
Description
Changes in carotid IMT and the total volume and number of unstable plaques before and after 6 months of treatment
Time Frame
6 moths
Secondary Outcome Measure Information:
Title
Changes in blood lipids
Description
The changes of triglyceride, total cholesterol, low density lipoprotein and high density lipoprotein before and after 6 months of treatment;
Time Frame
6 moths
Title
Number of new cardiovascular events
Description
Number of cardiovascular and cerebrovascular events during 6 months of treatment and 6 months of follow-up
Time Frame
12 moths
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Guangdong Province Hospital of Tradtional Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Proteomic Study and Early Intervention Study of Carotid Unstable Plaque
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