This study aims to evaluate the effectiveness and safety of Rosa roxburghii freeze-dried powder in reducing carotid atherosclerotic plaques. Carotid atherosclerosis is a major cause of ischemic stroke, and current treatments have safety limitations. Rosa roxburghii, a fruit used in traditional Chinese medicine, has shown potential in lowering lipids and reducing inflammation. In this randomized controlled trial, 200 participants with carotid plaques will be assigned to either conventional therapy alone or conventional therapy plus Rosa roxburghii freeze-dried powder (3 g/day for 6 months). The primary outcomes are changes in plaque size assessed by ultrasound and serum lipid levels. Secondary and exploratory outcomes include changes in inflammatory markers, gut microbiota composition, and metabolomic profiles. The study will provide clinical evidence on the use of Rosa roxburghii as an adjunctive therapy for atherosclerosis.
Participants clinically diagnosed with atherosclerosis (AS) by a specialist physician
Age between 40 and 80 years
Presence of at least one identifiable carotid plaque meeting all of the following criteria: (a) a focal structure protruding into the lumen; (b) on gray-scale ultrasound longitudinal/transverse sections, protrusion beyond the vascular intimal surface with a maximum thickness ≥ 1.5 mm compared with the adjacent normal vessel wall (1-2 cm proximal or distal to the plaque); (c) a local structure protruding into the lumen with a thickness ≥ 0.5 mm or > 50% of the surrounding intima-media thickness (IMT), accompanied by abnormal lipid metabolism markers
Diagnosis of carotid plaque and regular follow-up with the same physician at the study site
History of allergy to Rosa roxburghii juice or vitamin C preparations
Hyperlipidemia without detectable carotid plaques
Severe malnutrition
Concomitant liver or kidney disease
Parallel
Rosa Roxburghii Freeze-Dried Powder
Dietary supplementRosa roxburghii freeze-dried powder (3 g per sachet) administered orally at a dose of 3 g once daily after lunch for 6 months.
Conventional Anti-Atherosclerosis Therapy
DrugStandard-of-care treatment for atherosclerosis including statins (e.g., atorvastatin, rosuvastatin) and antiplatelet agents (e.g., aspirin) as prescribed by the attending physician according to clinical practice guidelines. Dosing and duration follow routine clinical management.
Change in Carotid Plaque Area
The change from baseline in the maximum cross-sectional area of carotid atherosclerotic plaques measured by carotid ultrasound at 6 months after initiation of treatment. Plaque area is quantified as the difference between baseline and 6-month measurements, with a negative value indicating reduction in plaque area.
Change in Serum Lipid Profile
Change from baseline in serum levels of total cholesterol, triglycerides, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol measured at 3 months and 6 months after treatment initiation.
Change in CD4+ T-Cell Proportion Among PBMCs
Change from baseline in the proportion of CD3+CD4+ T cells among viable peripheral blood mononuclear cells, measured by multiparameter flow cytometry and reported as a percentage (%).
Change in Inflammatory Cytokine Levels
Change from baseline in serum levels of inflammatory cytokines (including interleukin-6, tumor necrosis factor-alpha, and interleukin-1β) measured at 3 months and 6 months after treatment initiation.
Change in Gut Microbiota Shannon Diversity Index
Change from baseline in within-sample bacterial alpha diversity measured by 16S rRNA gene sequencing and reported as the unitless Shannon diversity index.
Incidence of Adverse Events
Proportion of participants experiencing treatment-emergent adverse events, assessed by clinical evaluation and laboratory tests throughout the study period and up to 28 days after the last dose of Rosa roxburghii freeze-dried powder.
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Xiangya Hospital of Central South University
Lead sponsor
The First People's Hospital of Guiyang
Collaborator
Sinopharm Group Tongjitang (Guizhou) Pharmaceutical Co., Ltd.
Collaborator
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