subclinical atherosclerosis
Conditions
Interventions
experimental group:Take the investigational product orally, 3 capsules before lunch and 3 capsules before bedtime, for a total of 6 capsules per day, continuously for 16 weeks
placebo-controlled:Take the placebo orally, 3 capsules before lunch and 3 capsules before bedtime, for a total of 6 capsules per day, continuously for 16 weeks.
Sponsors
Soochow University
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: [1] Aged 40–70 years, both males and females eligible; [2] Carotid intima-media thickness (IMT) = 1.0 mm; [3] Signed informed consent form.
Exclusion criteria
Exclusion criteria: [1] Diagnosed with ASCVD (e.g., coronary heart disease, ischemic stroke, peripheral arterial disease); [2] Carotid artery stenosis = 50%; [3] Currently taking statins (e.g., atorvastatin, rosuvastatin); [4] Pregnant or lactating women, or those planning to become pregnant during the trial period; [5] Severe cardiac, hepatic, or renal insufficiency; malignant tumors; mental disorders or cognitive impairment; [6] Known or suspected allergy to the investigational product or its excipients; [7] Participation in another drug clinical trial within 1 month prior to screening/enrollment; [8] Poor compliance as judged by the investigator, or any other condition that, in the investigator's opinion, makes the subject unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Carotid Intima-Media Thickness (CIMT); | — |
Secondary
| Measure | Time frame |
|---|---|
| Total carotid plaque area ;Overall treatment response rate ;Lipoprotein-associated phospholipase A2;Total Cholesterol (TC);Triglycerides (TG);Low-Density Lipoprotein Cholesterol (LDL-C);High-Density Lipoprotein Cholesterol (HDL-C);Fasting blood glucose;fasting insulin;Blood pressure ;Routine blood test ;Alanine Aminotransferase (ALT);Aspartate Aminotransferase (AST);uric acid;urea;creatinine; | — |
Countries
China
Contacts
Public ContactGuochong Chen
Soochow University
Outcome results
None listed