Mild carotid atherosclerotic plaques and dyslipidemia
Conditions
Interventions
Treatment group:Natto Monascus Capsules: 3 capsules each time, twice daily, orally taken
Sponsors
Guangdong Second Provincial General Hospital (Guangdong Provincial Emergency Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–65 years (inclusive), males or females; 2. Meet the criteria for borderline elevated LDL-C and dyslipidemia according to the Chinese Guidelines for Lipid Management (Primary Care Version 2024), i.e., after normal diet and fasting for 8–12 hours, LDL-C >=3.4 and <4.1 mmol/L, with no clear secondary cause; 3. Confirmed by color Doppler ultrasonography to have unilateral or bilateral carotid atherosclerotic plaques, with carotid artery stenosis <=50%; 4. Voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of cardiovascular or cerebrovascular diseases other than atherosclerosis, or history of vascular lesions in other sites; 2. Women who are pregnant, planning to become pregnant, or breastfeeding; 3. Inability to eat orally or to take the investigational product as required; 4. Participants allergic to any component of the investigational product; 5. History of mental illness, or history of drug abuse or alcohol abuse within 6 months prior to screening (alcohol abuse defined as consuming 14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine). 6. Abnormal liver function (ALT and/or AST >=1.5×ULN) and/or abnormal renal function (Scr >=1×ULN); 7. Participation in an interventional clinical trial within 1 month before enrollment; 8. Use of lipid-lowering drugs or other medications within the past two weeks that may affect the assessment of the study results; 9. Other conditions deemed by the investigator as inappropriate for participation in this study (including but not limited to poor compliance, living far from the study site, or inability to attend follow-up visits as scheduled).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Carotid atherosclerotic plaque area (at the maximum site); | — |
Secondary
| Measure | Time frame |
|---|---|
| Carotid intima-media thickness;Common carotid artery stenosis rate; | — |
Countries
China
Contacts
Public ContactZhang Xiaoxue
Guangdong Second Provincial General Hospital (Guangdong Provincial Emergency Hospital)
Outcome results
None listed