A randomized double blind placebo parallel controlled study on the effect of decoction of simiaoyongan on the plaque fiber cap thickness in patients with carotid atherosclerosis

Not Applicable

Recruiting

• Conditions: Carotid atherosclerosis

• Registration Number: ITMCTR2100004268
• Lead Sponsor: Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients with carotid atherosclerotic plaque diagnosed by color Doppler ultrasound;
2. Patients with hs CRP >= 2mg / L;
3. Patients aged between 40 and 80, regardless of gender;
4. Patients who can take medicine for a long time;
5. Patients who have informed consent shall sign the informed consent form.

Exclusion Criteria

1. Patients with acute or subacute hemorrhage in plaque;
2. Patients with complete calcification and fibrosis of plaque;
3. MRI contraindications (such as pacemaker, denture, stent, etc.);
4. Patients with active ulcer and bleeding tendency, long-term use of anticoagulant drugs (such as warfarin);
5. Patients using dual antiplatelet drugs;
6. Patients with severe arrhythmia, atrial fibrillation and heart failure;
7. Patients with severe primary diseases such as liver, kidney, hematopoietic system, endocrine system and respiratory system, whose liver function is more than 1.5 times higher than the upper limit of normal value, and Cr is higher than the normal value;
8. Patients with any other life-threatening or serious diseases can not complete the 12-month treatment, so as to affect the evaluation results;
9. Pregnant or lactating women, women with short-term pregnancy plans;
10. Patients with allergic constitution;
11. Patients with other diseases or psychosis that the researchers believe may limit the efficacy evaluation or follow-up of patients;
12. Patients who have participated in clinical trials of other drugs in recent 4 weeks.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Minimum fiber cap thickness;

Secondary Outcome Measures

Name	Time	Method
Blood lipid;Volume of Lipid-Rich Necrotic Core;Total vessel wall load (volume of vascular wall/total volume of blood vessels);High-sensitivityC-reactive protein;Volume of bleeding in plaque;Volume of plaque calcification;Volume percentage of plaque calcification;Maximum vascular wall thickness;Volume percentage of Lipid-Rich Necrotic Core;Blood glucose;Volume percentage of bleeding in plaque;Volume percentage of Fiber cap;Blood pressure;Weight;Volume of vascular wall;Average value of vascular wall thickness;Carotid Atherosclerosis Score;Vascular stenosis rate;Volume of Fiber cap;