Carotid Atherosclerosis, Hyperlipidemia
Conditions
Keywords
Hyperlipidemia, Carotid arteriosclerosis, baPWV
Brief summary
This study focuses on PWV as the main outcome, aiming to evaluate the efficacy and safety of ShenJu in treating patients with hyperlipidemia combined with carotid atherosclerosis, and provide a basis for traditional Chinese medicine treatment of hyperlipidemia combined with carotid atherosclerosis.
Detailed description
Hyperlipidemia is very harmful and easy to cause atherosclerosis. Atherosclerosis is the main factor of carotid atherosclerosis. Carotid atherosclerosis and plaque are usually the characteristic manifestations of atherosclerosis. Carotid arteriosclerosis is closely related to stroke, and carotid arteriosclerosis, rupture and detachment of carotid plaques, carotid stenosis and occlusion can all lead to the occurrence of cerebrovascular events. Early detection and evaluation of hyperlipidemia with carotid atherosclerosis by various means can effectively reduce the risk of cardiovascular and cerebrovascular diseases. In order to better serve the vast number of patients, Professor Wang Lei has developed ShenJu granules based on traditional Chinese medicine prescriptions and years of clinical experience. Compared to decoction, ShenJu granules have a higher concentration, are more convenient to carry, and are easy to absorb. They have received unanimous praise from patients in clinical applications.
Interventions
OTHERShenJu
One package per time, twice a day, 90 days of treatment
OTHERPlacebo
One package per time, twice a day, 90 days of treatment (the placebo was basically the same as ShenJu in terms of appearance, shape, color, taste, etc.)
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. The patient has informed consent and signed the informed consent form 2. Age between 18-65 years old 3. Meet the diagnostic criteria for hyperlipidemia and accompanied by carotid arteriosclerosis 4. Meet the diagnostic criteria of TCM wet certificate: refer to the scoring standard of TCM Wet Disease Scale
Exclusion criteria
1. Severe liver, kidney and cardiac insufficiency 2. Any other serious disease or condition such as: malignant tumor, uncontrolled severe hypertension, diabetic ketoacidosis (acute complication/vascular abnormality), arrhythmia, coagulation abnormalities 3. Have participated in another clinical study within 30 days prior to enrollment or have received a history of randomized ketoacidosis in this study 4. Pregnant women, women preparing to become pregnant and lactating women 5. Patients who are allergic to relevant Chinese medicine ingredients 6. Patients who have had a stent inserted 7. Patients who the investigator determines are not suitable to participate in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arm and ankle pulse wave velocity | At enrollment versus at day 90 | Measures the degree of carotid artery sclerosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipid indexes | At enrollment versus at day 90 | Total cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein, apolipoprotein (a), free fatty acids |
| Blood glucose | At enrollment versus at day 90 | blood glucose in mmol/L |
| Indicators of carotid atherosclerosis | At enrollment versus at day 90 | IMT value, IMT rate of change, common carotid peak systolic flow rate (PSV), peak diastolic flow rate (EDV), pulsatile index (PI), resistance index (RI) |
| TCM wet evidence | At enrollment versus at day 90 | Whether it is in the population with phlegm and wetness |
Countries
China
Contacts
Primary ContactLei Wang, M.D
Outcome results
None listed