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Practical Randomized Controlled Trial of Neixiao Ruanmai Decoction in Treating Carotid Atherosclerosis Plaque with Different Courses

Phase 1
Recruiting
Conditions
Atherosclerosis
Registration Number
ITMCTR2100004490
Lead Sponsor
Dongzhimen Hospital, Beijing University of Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

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 aged from 40 to 65, regardless of gender;
3. Patients with lumen stenosis less than 70%;
4. Patients who can take medicine for a long time;
5. 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 active ulcer and bleeding tendency, long-term use of anticoagulant drugs (such as warfarin);
4. Patients with severe arrhythmia, atrial fibrillation and heart failure;
5. 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;
6. Pregnant or lactating women, women with pregnancy plans in the near future;
7. Patients with allergic constitution;
8. Patients using dual antiplatelet drugs;
9. Any other life-threatening or serious disease that cannot be treated for 12 months will affect the evaluation results;
10. Other diseases or mental disorders that researchers believe may limit efficacy evaluation or patient follow-up;
11. 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
NameTimeMethod
Percentage decrease in plaque thickness (cross section);Plaque thickness reduction;
Secondary Outcome Measures
NameTimeMethod
Intima media thickness;blood lipids;serum glucose;body weight;Stenosis rate;Interleukin-6;High sensitivity C-reactive protein;Percentage of plaque area decrease (longitudinal section);Plaque area decline;blood pressure;
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