Evaluation of the clinical efficacy of Guanxinning tablets in the treatment of patients with carotid atherosclerotic plaque
- Conditions
- Carotid atherosclerotic plaque formation
- Registration Number
- ITMCTR2100005440
- Lead Sponsor
- Dongzhimen Hospital, Beijing University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) Participate voluntarily, understand and sign the informed consent form
(2) Age =18 years old and =75 years old, regardless of gender
(3) Meet the diagnostic criteria: IMT=1.5mm, protruding from the vascular cavity or limited thickening,
And higher than 50% of the surrounding IMT
(4) Syndrome differentiation accords with TCM Heart and Blood Stasis Syndrome
(1) Carotid artery plaque stenosis =70%
(2) History of carotid endarterectomy
(3) Poor hypertension control, defined as resting at two independent examinations before randomization
Systolic blood pressure =180mmHg and/or diastolic blood pressure =110mmHg
(4) Occurred within 3 months: acute coronary syndrome, stroke, transient brain deficiency
Blood attack; heart, carotid or other large blood vessel surgery; percutaneous coronary intervention or carotid movement
Angioplasty or coronary artery bypass graft and other heart surgery
(5) Major surgery within 6 months before randomization
(6) Patients with hemoglobin concentration =9g/dL and/or blood system diseases
(7) Patients with heart failure and severe arrhythmia (persistent rapid atrial fibrillation, atrial flutter, frequent
Ventricular premature, ventricular tachycardia, atrioventricular block above second degree), or combined with liver, kidney, hematopoietic system,
Nervous system, endocrine system and other serious primary diseases, tumor patients and mental patients
(8) Life expectancy is less than 1 year
(9) Participated in other drug clinical trials within 1 month
(10) Known to be allergic to the research drug (including its ingredients)
(11) Patients who are taking Chinese medicines or proprietary Chinese medicines that have similar ingredients to Guanxinning tablets or have the effect of resolving phlegm and turbidity
(12) Pregnancy (positive pregnancy test) or breastfeeding; failure to take medicine
Use women of childbearing age (15-49 years old) who observe strict contraceptive measures
(13) According to the judgement of the investigator, the patient cannot complete the study or cannot comply with the requirements of the study
Demand (due to management reasons or other reasons)
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Carotid artery intima-media thickness;
- Secondary Outcome Measures
Name Time Method Segmental fat analysis;Blood lipids;Cardiovascular and cerebrovascular disease incidence;Visceral fat grade;Body fat percentage;