Effects of Rosa Roxburghii Tratt Freeze-Dried Powder on Carotid Atherosclerotic Plaques: A Real-World Study (RRC-AS)
Mechanism of Action and Real-World Study of Rosa Roxburghii Tratt Freeze-Dried Juice Powder and Its Extracts Against Carotid Atherosclerotic Plaques
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.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
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Experimental: 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. |
Rosa roxburghii freeze-dried powder (3 g per sachet) administered orally at a dose of 3 g once daily after lunch for 6 months. Standard-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. |
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Comparador activo: 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. |
Standard-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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Carotid Plaque Area
Periodo de tiempo: Baseline and 6 months after treatment initiation
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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. |
Baseline and 6 months after treatment initiation
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Serum Lipid Profile
Periodo de tiempo: Baseline, 3 months, and 6 months
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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. |
Baseline, 3 months, and 6 months
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Change in CD4+ T-Cell Proportion Among PBMCs
Periodo de tiempo: Baseline, 3 months, and 6 months
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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 (%). |
Baseline, 3 months, and 6 months
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Change in Inflammatory Cytokine Levels
Periodo de tiempo: Baseline, 3 months, and 6 months
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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. |
Baseline, 3 months, and 6 months
|
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Change in Gut Microbiota Shannon Diversity Index
Periodo de tiempo: Baseline, 3 months, and 6 months
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Change from baseline in within-sample bacterial alpha diversity measured by 16S rRNA gene sequencing and reported as the unitless Shannon diversity index. |
Baseline, 3 months, and 6 months
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Change in CD8+ T-Cell Proportion Among PBMCs
Periodo de tiempo: Baseline, 3 months, and 6 months
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Change from baseline in the proportion of CD3+CD8+ T cells among viable peripheral blood mononuclear cells, measured by multiparameter flow cytometry and reported as a percentage (%). |
Baseline, 3 months, and 6 months
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Change in CD19+ B-Cell Proportion Among PBMCs
Periodo de tiempo: Baseline, 3 months, and 6 months
|
Change from baseline in the proportion of CD3-CD19+ B cells among viable peripheral blood mononuclear cells, measured by multiparameter flow cytometry and reported as a percentage (%). |
Baseline, 3 months, and 6 months
|
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Change in Natural Killer Cell Proportion Among PBMCs
Periodo de tiempo: Baseline, 3 months, and 6 months
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Change from baseline in the proportion of CD3-CD56+ natural killer cells among viable peripheral blood mononuclear cells, measured by multiparameter flow cytometry and reported as a percentage (%). |
Baseline, 3 months, and 6 months
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Change in CD4+/CD8+ T-Cell Ratio
Periodo de tiempo: Baseline, 3 months, and 6 months
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Change from baseline in the unitless ratio of CD3+CD4+ T-cell proportion to CD3+CD8+ T-cell proportion among viable peripheral blood mononuclear cells, measured by multiparameter flow cytometry. |
Baseline, 3 months, and 6 months
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Change in Gut Microbiota Chao1 Richness Index
Periodo de tiempo: Baseline, 3 months, and 6 months
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Change from baseline in estimated bacterial taxon richness measured by 16S rRNA gene sequencing and reported as the unitless Chao1 richness index. |
Baseline, 3 months, and 6 months
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Change in Relative Abundance of Prespecified Gut Bacterial Taxa
Periodo de tiempo: Baseline, 3 months, and 6 months
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Change from baseline in the relative abundance of each prespecified bacterial taxon measured by 16S rRNA gene sequencing and reported as the percentage of quality-filtered sequencing reads assigned to the taxon (%). |
Baseline, 3 months, and 6 months
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Change in Fecal Acetate Concentration
Periodo de tiempo: Baseline, 3 months, and 6 months
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Change from baseline in fecal acetate concentration measured by a validated gas chromatography-mass spectrometry (GC-MS) or liquid chromatography-mass spectrometry (LC-MS) assay and reported as micromoles per gram of wet stool (µmol/g). |
Baseline, 3 months, and 6 months
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Change in Fecal Propionate Concentration
Periodo de tiempo: Baseline, 3 months, and 6 months
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Change from baseline in fecal propionate concentration measured by a validated gas chromatography-mass spectrometry (GC-MS) or liquid chromatography-mass spectrometry (LC-MS) assay and reported as micromoles per gram of wet stool (µmol/g). |
Baseline, 3 months, and 6 months
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Change in Fecal Butyrate Concentration
Periodo de tiempo: Baseline, 3 months, and 6 months
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Change from baseline in fecal butyrate concentration measured by a validated gas chromatography-mass spectrometry (GC-MS) or liquid chromatography-mass spectrometry (LC-MS) assay and reported as micromoles per gram of wet stool (µmol/g). |
Baseline, 3 months, and 6 months
|
Otras medidas de resultado
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of Adverse Events
Periodo de tiempo: From enrollment through 28 days after last dose (up to approximately 7 months)
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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. |
From enrollment through 28 days after last dose (up to approximately 7 months)
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Carrera
- Accidente cerebrovascular isquémico
- Enfermedades de la arteria carótida
- Aterosclerosis
- Estenosis carotídea
Otros números de identificación del estudio
Otros números de identificación del estudio
- 2025112045
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Individual participant data will not be shared due to the following considerations: (1) The study protocol does not include provisions for data sharing with external researchers; (2) Participant confidentiality and privacy protection are paramount, and no explicit consent for data sharing was obtained from participants; (3) The data contain sensitive clinical information and are subject to applicable Chinese data protection regulations; and (4) Any future data sharing would require separate approval from the ethics committee and a formal data transfer agreement.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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