The Proteomic Study and Early Intervention Study of Carotid Unstable Plaque

Guangzhou University of Traditional Chinese Medicine

Status and phase: Not yet enrolling; Phase 1

Conditions: Carotid Artery Plaque; Traditional Chinese Medicine; Protein; Disease

Treatments: Drug: Zhu's Wenban Formula; Other: Basic treatment; Drug: Qushi Formula; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05622877

SZ2021ZZ3205

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 3 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

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);

Treatment:

Other: Basic treatment

Drug: placebo

Qushi Formula Group

Experimental group

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);

Treatment:

Drug: Qushi Formula

Other: Basic treatment

Zhu's Wenban Formula Group

Experimental group

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);

Treatment:

Drug: Zhu's Wenban Formula

Other: Basic treatment