A randomized double-blind placebo-controlled study of Zhixiong capsule in the treatment of carotid atherosclerosis (blood stasis syndrome)

Not Applicable

Not yet recruiting

• Conditions: Carotid atherosclerosis

• Registration Number: ITMCTR2100005447
• Lead Sponsor: Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 February 2023

Recruitment & Eligibility

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

Inclusion Criteria

1. Patients with carotid atherosclerotic plaque diagnosed by color Doppler ultrasound;
2. Patients with blood stasis syndrome of Traditional Chinese medicine
3. Patients aged from 40 to 65, regardless of gender;
4. Patients with lumen stenosis less than 70%;
5. Patients who can take medicine for a long time;
6. Patients with informed consent and those who signed the informed consent.

Exclusion Criteria

1. Patients with acute cardiovascular and cerebrovascular diseases;
2. Patients with previous history of cerebral hemorrhage;
3. Patients with coagulopathy;
4. Patients with active ulcer and bleeding tendency, long-term use of anticoagulant drugs (such as warfarin);
5. Patients with diagnosis of atherosclerotic vulnerable plaque formation;
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. Pregnant or lactating women, women with pregnancy plans in the near future;
9. Patients with allergic constitution;
10. Patients who are taking lipid-lowering medications
11. Patients who are taking dual antiplatelet drugs;
12. Any other life-threatening or serious disease that cannot be treated for 12 months will affect the evaluation results;
13. Other diseases or mental disorders that researchers believe may limit efficacy evaluation or patient follow-up;
14. 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
Percentage decrease in plaque thickness (cross section);Plaque thickness reduction;

Secondary Outcome Measures

Name	Time	Method
blood lipids;Stenosis rate;Intima media thickness;blood pressure;Plaque area decline;Percentage of plaque area decrease (longitudinal section);