Hyperlipidemia Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled Study of ShenJu in the Treatment of Hyperlipidemia Combined With Carotid Atherosclerosis
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 30, 2023 |
Est. primary completion date | October 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Guangdong Provincial Hospital of Chinese Medicine | Guangzhou | Guangdong |
China | WangLei | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Guangdong Provincial Hospital of Traditional Chinese Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Arm and ankle pulse wave velocity | Measures the degree of carotid artery sclerosis | At enrollment versus at day 90 | |
Secondary | Blood glucose | blood glucose in mmol/L | At enrollment versus at day 90 | |
Secondary | Lipid indexes | Total cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein, apolipoprotein (a), free fatty acids | At enrollment versus at day 90 | |
Secondary | Indicators of carotid atherosclerosis | IMT value, IMT rate of change, common carotid peak systolic flow rate (PSV), peak diastolic flow rate (EDV), pulsatile index (PI), resistance index (RI) | At enrollment versus at day 90 | |
Secondary | TCM wet evidence | Whether it is in the population with phlegm and wetness | At enrollment versus at day 90 |
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