Effects of Rosa Roxburghii Tratt Freeze-Dried Powder on Carotid Atherosclerotic Plaques: A Real-World Study

Atherosclerosis, particularly carotid artery plaque, is a critical risk factor for acute ischemic stroke. Current pharmacological interventions, such as statins, are effective but have safety concerns that limit long-term use. Rosa roxburghii Tratt, a food-medicine homology plant, possesses antioxidant, anti-inflammatory, and lipid-regulating properties. Preclinical studies suggest that its active components may modulate lipid metabolism and inflammation, potentially through gut microbiota-mediated pathways.

This study is a multicenter, randomized, parallel-controlled, real-world clinical trial designed to investigate the efficacy and safety of Rosa roxburghii freeze-dried powder in patients with carotid atherosclerotic plaques. A total of 200 participants meeting the inclusion criteria will be enrolled and randomly assigned in a 1:1 ratio to either the experimental group (conventional anti-atherosclerosis therapy plus Rosa roxburghii freeze-dried powder 3 g/day orally for 6 months) or the control group (conventional therapy alone). Conventional therapy includes statins and antiplatelet agents prescribed according to standard clinical practice.

The study consists of a screening period, a 6-month treatment period, and a 2-month follow-up period. Clinical assessments are scheduled at baseline, 3 months, and 6 months. The primary outcome measures are the change from baseline in carotid plaque area assessed by ultrasound and serum lipid levels (total cholesterol, triglycerides, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol) at 6 months. Secondary outcome measures include changes in peripheral blood mononuclear cell characteristics and gut microbiota composition with metabolomic profiles. Safety outcomes include the incidence of adverse events and serious adverse events.

Biological samples (fasting blood and feces) are collected at baseline, 3 months, and 6 months for mechanistic studies. Blood samples will be used for peripheral blood mononuclear cell isolation and biomarker analysis. Fecal samples will undergo 16S rRNA sequencing and untargeted metabolomics to explore the gut microbiota-metabolite axis underlying the intervention effects. The sample size calculation assumed a 90% power and a 30% attrition rate, yielding 100 participants per group. Statistical analyses will include descriptive statistics, correlation analyses for efficacy, and safety evaluations using CTCAE criteria. This study is expected to provide robust clinical evidence on the efficacy and mechanism of Rosa roxburghii as an adjunctive therapy for carotid atherosclerosis, potentially offering a safe and accessible option for stroke prevention.

Inclusion criteria

• 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
• Willingness to refrain from participating in other clinical studies and to complete the full treatment regimen during the study period
• Voluntarily sign the informed consent form after being fully informed

Exclusion criteria

• History of allergy to Rosa roxburghii juice or vitamin C preparations
• Hyperlipidemia without detectable carotid plaques
• Severe malnutrition
• Concomitant liver or kidney disease
• Pregnancy or lactation
• Psychiatric disorders or inability to cooperate with the study procedures
• Diagnosis of diabetes mellitus or hypertension
• Use of antibiotics, probiotics, prebiotics, laxatives, or traditional Chinese medicine within 3 months prior to enrollment
• Any condition that, in the investigator's opinion, makes the participant unsuitable for enrollment