An interventional study of Rosa Roxburghii Freeze-Dried Powder and Conventional Anti-Atherosclerosis Therapy in Carotid Artery Plaques, Atherosclerosis and Ischemic Stroke, sponsored by Xiangya Hospital of Central South University. Not yet recruiting. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Xiangya Hospital of Central South University · Not applicable, Interventional, and Treatment
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.
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.
364 studies on the registry are indexed under Carotid Stenosis; 85 are open to participants now.
This study's planned enrollment of 200 is above the median of 103 across 189 interventional studies indexed under Carotid Stenosis.
Browse Carotid Stenosis studies →Xiangya Hospital of Central South University is the lead sponsor of 174 studies on the registry; 77 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Rosa Roxburghii Freeze-Dried Powder · Drug: Conventional Anti-Atherosclerosis Therapy
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.
Drug: Conventional Anti-Atherosclerosis Therapy
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.
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.
Time frame: Baseline and 6 months after treatment initiation
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.
Time frame: Baseline, 3 months, and 6 months
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 (%).
Time frame: Baseline, 3 months, and 6 months
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.
Time frame: Baseline, 3 months, and 6 months
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.
Time frame: Baseline, 3 months, and 6 months
Change in CD8+ T-Cell Proportion Among PBMCs
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 (%).
Time frame: Baseline, 3 months, and 6 months
Change in CD19+ B-Cell Proportion Among PBMCs
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 (%).
Time frame: Baseline, 3 months, and 6 months
Change in Natural Killer Cell Proportion Among PBMCs
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 (%).
Time frame: Baseline, 3 months, and 6 months
Change in CD4+/CD8+ T-Cell Ratio
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.
Time frame: Baseline, 3 months, and 6 months
Change in Gut Microbiota Chao1 Richness Index
Change from baseline in estimated bacterial taxon richness measured by 16S rRNA gene sequencing and reported as the unitless Chao1 richness index.
Time frame: Baseline, 3 months, and 6 months
Change in Relative Abundance of Prespecified Gut Bacterial Taxa
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 (%).
Time frame: Baseline, 3 months, and 6 months
Change in Fecal Acetate Concentration
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).
Time frame: Baseline, 3 months, and 6 months
Change in Fecal Propionate Concentration
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).
Time frame: Baseline, 3 months, and 6 months
Change in Fecal Butyrate Concentration
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).
Time frame: Baseline, 3 months, and 6 months
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.
Time frame: From enrollment through 28 days after last dose (up to approximately 7 months)
No study locations are listed for this record.
Plan to share: No — 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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