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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004268
Enrollment
Unknown
Registered
2020-10-15
Start date
2020-10-26
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Carotid atherosclerosis

Interventions

Sponsors

Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Minimum fiber cap thickness;

Secondary

MeasureTime frame
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;

Countries

China

Contacts

Public ContactWu Shengxian

Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine

wushx@sina.com+86 13501382919

Outcome results

None listed

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