Mechanism of Action and Real-World Study of Rosa Roxburghii Tratt Freeze-Dried Juice Powder and Its Extracts Against Carotid Atherosclerotic Plaques
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Change in Carotid Plaque Area
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study. No masking is applied, as participants, investigators, and outcome assessors are aware of the assigned interventions. The open-label design is due to the nature of the intervention (oral administration of Rosa roxburghii freeze-dried powder) and the absence of a placebo control. To minimize potential bias, objective outcome measures (e.g., ultrasound assessment of plaque size, laboratory parameters) are used, and outcome assessors will be independent and blinded to group assignment during data analysis where feasible.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Rosa Roxburghii Freeze-Dried Powder Plus Conventional Therapy
Participants receive conventional anti-atherosclerosis therapy (including statins, antiplatelet agents such as aspirin, as prescribed by the attending physician) plus Rosa roxburghii freeze-dried powder administered orally at a dose of 3 g once daily after lunch for 6 months.
干预措施: Rosa Roxburghii Freeze-Dried Powder (Dietary Supplement)
Rosa Roxburghii Freeze-Dried Powder Plus Conventional Therapy
Participants receive conventional anti-atherosclerosis therapy (including statins, antiplatelet agents such as aspirin, as prescribed by the attending physician) plus Rosa roxburghii freeze-dried powder administered orally at a dose of 3 g once daily after lunch for 6 months.
干预措施: Conventional Anti-Atherosclerosis Therapy (Drug)
Conventional Therapy Alone
Participants receive conventional anti-atherosclerosis therapy (including statins, antiplatelet agents such as aspirin, as prescribed by the attending physician) without Rosa roxburghii supplementation. Treatment follows standard clinical practice.
干预措施: Conventional Anti-Atherosclerosis Therapy (Drug)
结局指标
主要结局
Change in Carotid Plaque Area
时间窗: Baseline and 6 months after treatment initiation
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.
次要结局
- Change in Serum Lipid Profile(Baseline, 3 months, and 6 months)
- Change in CD4+ T-Cell Proportion Among PBMCs(Baseline, 3 months, and 6 months)
- Change in Inflammatory Cytokine Levels(Baseline, 3 months, and 6 months)
- Change in Gut Microbiota Shannon Diversity Index(Baseline, 3 months, and 6 months)
- Change in CD8+ T-Cell Proportion Among PBMCs(Baseline, 3 months, and 6 months)
- Change in CD19+ B-Cell Proportion Among PBMCs(Baseline, 3 months, and 6 months)
- Change in Natural Killer Cell Proportion Among PBMCs(Baseline, 3 months, and 6 months)
- Change in CD4+/CD8+ T-Cell Ratio(Baseline, 3 months, and 6 months)
- Change in Gut Microbiota Chao1 Richness Index(Baseline, 3 months, and 6 months)
- Change in Relative Abundance of Prespecified Gut Bacterial Taxa(Baseline, 3 months, and 6 months)
- Change in Fecal Acetate Concentration(Baseline, 3 months, and 6 months)
- Change in Fecal Propionate Concentration(Baseline, 3 months, and 6 months)
- Change in Fecal Butyrate Concentration(Baseline, 3 months, and 6 months)