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Evaluation of clinical effect of Mailuo Shutong pill on carotid arteriosclerosis and vulnerable plaque with wet and hot stasis

Evaluation of clinical effect of Mailuo Shutong pill on carotid arteriosclerosis and vulnerable plaque with wet and hot stasis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021855
Enrollment
Unknown
Registered
2019-03-13
Start date
2019-03-01
Completion date
Unknown
Last updated
2019-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid arteriosclerosis accompanied by fragile plaque

Interventions

Experimental group:Mailuo Shutong pill
Placebo group:Comfort Agent

Sponsors

First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Comply with the diagnostic criteria of Western medicine, Western medicine diagnostic criteria: According to the 2017 Chinese Medical Association Neurology branch of the brain vascular disease diagnosis and treatment of Chinese head and neck atherosclerosis consensus and 2003 American Radiological Conference ultrasound meeting published ultrasound diagnostic criteria: Carotid artery ultrasound can clearly show the plaque properties of the carotid artery. The plaque can be divided into high echo plaque by ultrasonic grayscale image, such as echo plaque, low echo plaque and heterogeneous echo Plaque: (1) Heterogeneous echo Plaque contains many lipid components, necrotic substances or plaque internal bleeding, often suggested as vulnerable plaque; (2) high echo plaque is more calcified or rich in fiber composition, indicating that the plaque is more stable; (3) Vascular ultrasound showed that the surface of the plaque was irregular or the SAG was greater than 2mm, which indicated that the ulcer was formed. Diagnostic criteria for Carotid plaque ultrasound: (1) Carotid intima thickening: inner-medium film thickness is not less than 1.0 Mm; (2) plaque: Limited Internal-medium film thickness is not less than 1.5 mm; (3) Plaque Composition: The top is the fiber cap, the body part is the core part and the base Part 3 parts. 2. Meet the diagnostic criteria of TCM; 3. Aged between 40-80 years; 4. Patients with carotid arteriosclerosis plaque who have not been treated with medication, or who have been treated with medication but have discontinued the relevant drug for more than two weeks; 5. After the score of TCM symptom integral scale, the syndrome is wet and hot stasis type; 6. informed and voluntary participation.

Exclusion criteria

Exclusion criteria: 1. Patients with acute stroke; 2. Persons who have recently undergone major surgery or suffered trauma; 3. Patients with severe heart, liver and kidney failure; 4. Patients with connective tissue disease, various vascular inflammation, etc.; 5. Patients with digestive tract ulcers; 6. Patients with allergic physique.

Design outcomes

Primary

MeasureTime frame
Related indexes of carotid artery ultrasound;Serum Inflammatory Index;Blood lipid levels;

Countries

China

Contacts

Public ContactDaojun Xie

First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

shlixiang2007@126.com+86 13305511316

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026