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

NCT07840950 | Not Yet Recruiting DMC

• 1 other identifier: 2025112045
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Carotid Artery Plaques; Atherosclerosis; Ischemic Stroke

Keywords

Rosa roxburghii; Carotid atherosclerosis; Plaque regression; Lipid metabolism; Gut microbiota; Real-world study; Traditional Chinese medicine; Food-medicine homology

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 months after treatment initiation

Secondary Outcomes (13)

• 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

Other Outcomes (1)

• Incidence of Adverse Events

  From enrollment through 28 days after last dose (up to approximately 7 months)

Study Arms (2)

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.

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.

Drug: Conventional Anti-Atherosclerosis Therapy

Interventions

Rosa Roxburghii Freeze-Dried Powder DIETARY_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.

Rosa Roxburghii Freeze-Dried Powder Plus Conventional Therapy

Conventional Anti-Atherosclerosis Therapy DRUG

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.

Conventional Therapy Alone; Rosa Roxburghii Freeze-Dried Powder Plus Conventional Therapy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First People's Hospital of Guiyang: collaborator
• Xiangya Hospital of Central South University: lead
• Sinopharm Group Tongjitang (Guizhou) Pharmaceutical Co., Ltd.: collaborator

MeSH Terms

Conditions

Carotid Stenosis; Atherosclerosis; Ischemic Stroke; Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Stroke

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 25, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: September 25, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share