Carotid Artery PlaquesRRC-ASNCT07840950
Effects of Rosa Roxburghii Tratt Freeze-Dried Powder on Carotid Atherosclerotic Plaques: A Real-World Study
A study testing Rosa Roxburghii Freeze-Dried Powder and Conventional Anti-Atherosclerosis Therapy in people with Carotid Artery Plaques and Atherosclerosis, run by Xiangya Hospital of Central South University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Carotid Artery Plaques, Atherosclerosis, Ischemic Stroke
- What is being tested?
- Rosa Roxburghii Freeze-Dried Powder and Conventional Anti-Atherosclerosis Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Jan 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Carotid Artery Plaques, Atherosclerosis, Ischemic Stroke
- Being tested
- Rosa Roxburghii Freeze-Dried Powder, Conventional Anti-Atherosclerosis Therapy
- Keywords
- Rosa roxburghii, Carotid atherosclerosis, Plaque regression, Lipid metabolism, Gut microbiota, Real-world study, Traditional Chinese medicine, Food-medicine homology
- Medical subject headings
- Carotid Stenosis, Atherosclerosis, Ischemic Stroke, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosa Roxburghii Freeze-Dried PowderDietary supplement
Rosa 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 TherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Rosa Roxburghii Freeze-Dried Powder Plus Conventional Therapy | Experimental | 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. Receives: Dietary Supplement: Rosa Roxburghii Freeze-Dried Powder; Drug: Conventional Anti-Atherosclerosis Therapy |
| Conventional Therapy Alone | Active comparator | 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. Receives: Drug: Conventional Anti-Atherosclerosis Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months after treatment initiation
Secondary outcomes (13)
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.
Measured: 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 (%).
Measured: 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.
Measured: 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.
Measured: 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 (%).
Measured: 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 (%).
Measured: 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 (%).
Measured: 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.
Measured: 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.
Measured: 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 (%).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery PlaquesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study employs a parallel-group design with two arms: an experimental group receiving conventional anti-atherosclerosis therapy plus Rosa roxburghii freeze-dried powder, and an active comparator group receiving conventional therapy alone. Participants are randomized in a 1:1 allocation ratio. The treatment period lasts 6 months, followed by a 2-month safety follow-up period. No crossover or factorial design is applied. The parallel assignment allows for direct comparison of the intervention effect between the two independent groups while minimizing carryover effects.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- The First People's Hospital of Guiyang, Sinopharm Group Tongjitang (Guizhou) Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840950
- Sponsor's protocol ID
- 2025112045
- Acronym
- RRC-AS
- Status last verified
- Apr 2026
- First submitted
- 14 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.