The Proteomic Study and Early Intervention Study of Carotid Unstable Plaque

NCT ID: NCT05622877

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2024-12-31

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.

Conditions

Protein; Disease; Carotid Artery Plaque; Traditional Chinese Medicine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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);

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

The placebo was composed of dextrin, powdered sugar, starch, and liquid caramel in the same color as the other two groups.

Basic treatment

Intervention Type: OTHER

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.

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);

Group Type: EXPERIMENTAL

Qushi Formula

Intervention Type: DRUG

Qushi Formula are decoction granules composed 8 traditional Chinese medicines, such as poria cocos, Macrocephalae Rhizoma, Polyporus, cassia twig, dried ginger and licorice, Etc.

Basic treatment

Intervention Type: OTHER

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.

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);

Group Type: EXPERIMENTAL

Zhu's Wenban Formula

Intervention Type: DRUG

Zhu's Wenban granules are decoction granules composed of leech, panax notoginseng, Atractylodes Lancea and rhizome

Basic treatment

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

Zhu's Wenban Formula

Zhu's Wenban granules are decoction granules composed of leech, panax notoginseng, Atractylodes Lancea and rhizome

Intervention Type: DRUG

placebo

The placebo was composed of dextrin, powdered sugar, starch, and liquid caramel in the same color as the other two groups.

Intervention Type: DRUG

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

jianwen guo, MD

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guangdong Province Hospital of Tradtional Chinese Medicine

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

SZ2021ZZ3205

Identifier Type: -

Identifier Source: org_study_id