OsteoarthritisNCT07395856
A Study on Rosa Roxburghii for Knee Replacement Recovery
A study testing Rosa roxburghii in people with Osteoarthritis, run by Shuguang Gao.
Trial summary
This clinical trail is to investigates the effect of Rosa roxburghii juice freeze-dried powder on the recovery of patients undergoing total knee arthroplasty due to knee osteoarthritis. The participants are divided into an experimental group and a placebo group. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Rosa roxburghii
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2026to 15 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnostic criteria for primary knee osteoarthritis (KOA) as defined by the "Chinese Guidelines for the Diagnosis and Treatment of Osteoarthritis (2019 Edition)."
- Aged between 18 and 75 years.
- No history of trauma or surgery involving the lower limbs. Scheduled to undergo total knee arthroplasty (TKA) performed by the same surgical team at the participating hospital.
- Willing to refrain from participating in any other clinical research studies for the duration of this trial.
- Agrees to adhere to the complete study treatment regimen.
- Able and willing to provide written informed consent.
Who cannot join
- Has a preoperative knee joint infection, rheumatoid arthritis, or other concurrent inflammatory or non-inflammatory joint disease.
- Has a history of any prior knee surgery (including revision procedures).
- Has diabetes mellitus with poorly controlled glucose levels (fasting blood glucose >7.2 mmol/L or 2-hour postprandial blood glucose >11.1 mmol/L).
- Has severe, unstable, or uncontrolled disease of the circulatory, respiratory, or hematopoietic systems.
- Has obesity defined as a body mass index (BMI) ≥30 kg/m².
- Has a diagnosis of severe osteoporosis.
- Is pregnant or currently breastfeeding.
- Has an active psychiatric disorder or any other condition that, in the investigator's judgment, would impair the ability to provide informed consent or comply with study procedures.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Study on the Involvement of Rosa Roxburghii in Oxidative Stress in Knee Osteoarthritis and Its Impact on Rehabilitation of Patients After Total Knee Arthroplasty
This clinical trail is to investigates the effect of Rosa roxburghii juice freeze-dried powder on the recovery of patients undergoing total knee arthroplasty due to knee osteoarthritis. The participants are divided into an experimental group and a placebo group. Enrolled patients will take 3g of Rosa roxburghii juice freeze-dried powder or a placebo dissolved in 400-500ml of warm water with breakfast daily, starting from the day after surgery and continuing for 30 consecutive days. Data on inflammatory markers, oxidative stress indicators, and knee function scores will be collected from the participants one day before surgery, as well as on the first, third, and thirtieth days after surgery.
Read the detailed description
Cohort Setting: Two cohorts: Intervention group (TTRJ group) receiving standard postoperative rehabilitation plus freeze-dried RRTJ juice powder; Control group receiving standard postoperative rehabilitation plus an equal dose of placebo.
Perioperative Management:
- Anesthesia: All patients receive postoperative analgesia education and VAS scale training one day preoperatively and sign informed consent. Routine fasting for 12 hours preoperatively. Upon entering the operating room, venous access is established, and ECG, non-invasive blood pressure, and pulse oximetry are monitored. General anesthesia is used.
- Surgical Procedure: TKA via anterior midline approach. After incising the deep fascia, the patella is everted to expose the joint surfaces. Hyperplastic synovium within the joint cavity is excised, preserving the infrapatellar fat pad. Distal femur, tibial plateau, anterior/posterior femoral condyles, chamfer, and intercondylar notch cuts are performed. Trial components are placed, and alignment is checked. Synovectomy around the patellar margin is performed, with patellofemoral joint shaping and denervation. The surgical field is thoroughly irrigated. Bone cement is mixed, prostheses are implanted, and the wound is closed in layers and dressed. Treatment Methods:
- Control Group: Within 24h postoperatively, anteroposterior and lateral knee X-rays are taken to confirm proper prosthesis placement. Patients are instructed to perform knee function rehabilitation exercises according to the plan. Starting from the first postoperative day, patients take placebo 3g/day after breakfast, dissolved in 200ml of warm water (40-50°C), for 4 consecutive weeks.
- TTRJ Group: Within 24h postoperatively, anteroposterior and lateral knee X-rays are taken to confirm proper prosthesis placement. Patients are instructed to perform knee function rehabilitation exercises according to the plan. Starting from the first postoperative day, patients take freeze-dried RRTJ powder 3g/day after breakfast, dissolved in 200ml of warm water (40-50°C), for 4 consecutive weeks. The freeze-dried RRTJ juice powder used is the "Jin Ci Li" brand produced by China National Pharmaceutical Group Guizhou Great Health Industry Development Co., Ltd.
Measurement Parameters:
- Baseline Data: Gender, age, BMI, ethnicity, occupation, education level, living and residential situation, medical history, etc.
- Intraoperative Parameters: Operation duration, anesthesia duration, intraoperative blood loss, intraoperative average heart rate and blood pressure, etc.
- Record adverse reactions such as wound bleeding, infection, etc.
- Oxidative Stress Markers: Superoxide dismutase (SOD) and malondialdehyde (MDA) content measured by ELISA at preoperative 24h, postoperative 24h, 72h, and 4 weeks.
- Inflammatory Markers (4ml blood per draw): TNF-α, IL-1, IL-6 levels measured by ELISA at preoperative 24h, postoperative 24h, and 72h.
- Visual Analogue Scale (VAS) Pain Score: Recorded at preoperative 24h, postoperative 24h, 72h, and 4 weeks during rest and activity (walking or maximum knee flexion). Patients are explained the VAS before assessment.
- American Knee Society (AKS) Score: Recorded at preoperative 24h, postoperative 24h, 72h, and 4 weeks.
- Conditions
- Osteoarthritis
- Being tested
- Rosa roxburghii, Placebo
- Keywords
- Rosa roxburghii, Total Knee Arthroplasty, Osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosa roxburghiiDietary supplement
Enrolled patients will take 3g of Rosa roxburghii juice freeze-dried powder dissolved in 400-500ml of warm water with breakfast daily, starting from the day after surgery and continuing for 30 consecutive days.
PlaceboOther
Starting from the first postoperative day, patients take placebo 3g/day after breakfast, dissolved in 200ml of warm water (40-50°C), for 4 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Rosa roxburghii | Experimental | Not described Receives: Dietary Supplement: Rosa roxburghii |
| placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative Stress Markers
Superoxide Dismutase (SOD):
SOD activity will be measured in serum using a commercially available human-specific ELISA kit, following the manufacturer's instructions. Results are reported in U/L.
Malondialdehyde (MDA):
MDA concentration will be quantified in serum using a commercial ELISA kit based on the TBARS assay, following the manufacturer's protocol. Results are reported in nmol/mL or µmol/L.
Measured: Preoperative 24 hours, postoperative 24 hours, postoperative 72 hours, and postoperative 4 weeks.
Inflammatory Markers
Tumor Necrosis Factor-alpha (TNF-α), Interleukin-1 (IL-1), Interleukin-6 (IL-6): The concentrations of these pro-inflammatory cytokines will be measured in serum. Quantitative detection will be performed using specific, validated human ELISA kits. These cytokines are central mediators of the systemic inflammatory response; elevated levels post-surgery are associated with pain, tissue catabolism, and delayed recovery. The assay results will provide concentrations in picograms per milliliter (pg/mL).
Measured: Preoperative 24 hours, postoperative 24 hours, and postoperative 72 hour.
Visual Analogue Scale (VAS) Pain Score
Assessment Method: Pain intensity will be subjectively assessed by the patient using a 100-mm horizontal line Visual Analogue Scale. The left endpoint (0 mm) is labeled "No pain," and the right endpoint (100 mm) is labeled "Worst imaginable pain." Patients will be instructed to mark a point on the line that best represents their pain intensity at that moment.
Scoring: The distance from the "No pain" endpoint to the patient's mark is measured in millimeters, providing a score from 0 to 100. A higher score indicates greater pain intensity.
Measured: Preoperative 24 hours, postoperative 24 hours, postoperative 72 hours, and postoperative 4 weeks
American Knee Society (AKS) Score
Assessment Components: The AKS Score is a physician-administered assessment comprising two separate sub-scores:
Knee Score (0-100 points): Evaluates the knee joint itself, focusing on pain (50 points), stability (25 points), and range of motion (25 points), while deducting points for flexion contracture, extension lag, and malalignment.
Function Score (0-100 points): Evaluates the patient's functional ability, assessing walking distance (50 points) and stair climbing (50 points). The use of walking aids leads to point deductions.
Criteria and Definition: A higher total score indicates better knee function and less impairment. The assessment will be performed by a trained orthopedic surgeon or research nurse through patient interview and physical examination. Specific criteria for pain levels, range of motion measurement using a goniometer, ligament stability tests, and observation of gait and stair navigation will be applied strictly according to the official AKS guidelines.
Measured: Preoperative 24 hours, postoperative 24 hours, postoperative 72 hours, and postoperative 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start15 Jan 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shuguang Gao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shuguang Gao, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395856
- Sponsor's protocol ID
- KYH20250018
- Status last verified
- Feb 2026
- First submitted
- 9 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Involvement of Rosa Roxburghii in Oxidative Stress in Knee Osteoarthritis and Its Impact on Rehabilitation of Patients After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07395856
- Acronym / sponsor ID
- KYH20250018
- Conditions
- Osteoarthritis
- Keywords
- Rosa roxburghii, Total Knee Arthroplasty, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Shuguang GaoUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trail is to investigates the effect of Rosa roxburghii juice freeze-dried powder on the recovery of patients undergoing total knee arthroplasty due to knee osteoarthritis. The participants are divided into an experimental group and a placebo group. Enrolled patients will take 3g of Rosa roxburghii juice freeze-dried powder or a placebo dissolved in 400-500ml of warm water with breakfast daily, starting from the day after surgery and continuing for 30 consecutive days. Data on inflammatory markers, oxidative stress indicators, and knee function scores will be collected from the participants one day before surgery, as well as on the first, third, and thirtieth days after surgery.
Detailed description
Cohort Setting: Two cohorts: Intervention group (TTRJ group) receiving standard postoperative rehabilitation plus freeze-dried RRTJ juice powder; Control group receiving standard postoperative rehabilitation plus an equal dose of placebo.
Perioperative Management:
- Anesthesia: All patients receive postoperative analgesia education and VAS scale training one day preoperatively and sign informed consent. Routine fasting for 12 hours preoperatively. Upon entering the operating room, venous access is established, and ECG, non-invasive blood pressure, and pulse oximetry are monitored. General anesthesia is used.
- Surgical Procedure: TKA via anterior midline approach. After incising the deep fascia, the patella is everted to expose the joint surfaces. Hyperplastic synovium within the joint cavity is excised, preserving the infrapatellar fat pad. Distal femur, tibial plateau, anterior/posterior femoral condyles, chamfer, and intercondylar notch cuts are performed. Trial components are placed, and alignment is checked. Synovectomy around the patellar margin is performed, with patellofemoral joint shaping and denervation. The surgical field is thoroughly irrigated. Bone cement is mixed, prostheses are implanted, and the wound is closed in layers and dressed. Treatment Methods:
- Control Group: Within 24h postoperatively, anteroposterior and lateral knee X-rays are taken to confirm proper prosthesis placement. Patients are instructed to perform knee function rehabilitation exercises according to the plan. Starting from the first postoperative day, patients take placebo 3g/day after breakfast, dissolved in 200ml of warm water (40-50°C), for 4 consecutive weeks.
- TTRJ Group: Within 24h postoperatively, anteroposterior and lateral knee X-rays are taken to confirm proper prosthesis placement. Patients are instructed to perform knee function rehabilitation exercises according to the plan. Starting from the first postoperative day, patients take freeze-dried RRTJ powder 3g/day after breakfast, dissolved in 200ml of warm water (40-50°C), for 4 consecutive weeks. The freeze-dried RRTJ juice powder used is the "Jin Ci Li" brand produced by China National Pharmaceutical Group Guizhou Great Health Industry Development Co., Ltd.
Measurement Parameters:
- Baseline Data: Gender, age, BMI, ethnicity, occupation, education level, living and residential situation, medical history, etc.
- Intraoperative Parameters: Operation duration, anesthesia duration, intraoperative blood loss, intraoperative average heart rate and blood pressure, etc.
- Record adverse reactions such as wound bleeding, infection, etc.
- Oxidative Stress Markers: Superoxide dismutase (SOD) and malondialdehyde (MDA) content measured by ELISA at preoperative 24h, postoperative 24h, 72h, and 4 weeks.
- Inflammatory Markers (4ml blood per draw): TNF-α, IL-1, IL-6 levels measured by ELISA at preoperative 24h, postoperative 24h, and 72h.
- Visual Analogue Scale (VAS) Pain Score: Recorded at preoperative 24h, postoperative 24h, 72h, and 4 weeks during rest and activity (walking or maximum knee flexion). Patients are explained the VAS before assessment.
- American Knee Society (AKS) Score: Recorded at preoperative 24h, postoperative 24h, 72h, and 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosa roxburghii | Experimental | Dietary Supplement: Rosa roxburghii |
| placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnostic criteria for primary knee osteoarthritis (KOA) as defined by the "Chinese Guidelines for the Diagnosis and Treatment of Osteoarthritis (2019 Edition)."
- Aged between 18 and 75 years.
- No history of trauma or surgery involving the lower limbs. Scheduled to undergo total knee arthroplasty (TKA) performed by the same surgical team at the participating hospital.
- Willing to refrain from participating in any other clinical research studies for the duration of this trial.
- Agrees to adhere to the complete study treatment regimen.
Key exclusion criteria (8 listed)
- Has a preoperative knee joint infection, rheumatoid arthritis, or other concurrent inflammatory or non-inflammatory joint disease.
- Has a history of any prior knee surgery (including revision procedures).
- Has diabetes mellitus with poorly controlled glucose levels (fasting blood glucose >7.2 mmol/L or 2-hour postprandial blood glucose >11.1 mmol/L).
- Has severe, unstable, or uncontrolled disease of the circulatory, respiratory, or hematopoietic systems.
- Has obesity defined as a body mass index (BMI) ≥30 kg/m².
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosa roxburghiiEnrolled patients will take 3g of Rosa roxburghii juice freeze-dried powder dissolved in 400-500ml of warm water with breakfast daily, starting from the day after surgery and continuing for 30 consecutive days. | Dietary supplement | Rosa roxburghii |
| PlaceboStarting from the first postoperative day, patients take placebo 3g/day after breakfast, dissolved in 200ml of warm water (40-50°C), for 4 consecutive weeks. | Other | placebo |
Primary outcome
Oxidative Stress Markers
Time frame: Preoperative 24 hours, postoperative 24 hours, postoperative 72 hours, and postoperative 4 weeks.
Superoxide Dismutase (SOD): SOD activity will be measured in serum using a commercially available human-specific ELISA kit, following the manufacturer's instructions. Results are reported in U/L. Malondialdehyde (MDA): MDA concentration will be quantified in serum using a commercial ELISA kit based on the TBARS assay, following the manufacturer's protocol. Results are reported in nmol/mL or µmol/L.
Inflammatory Markers
Time frame: Preoperative 24 hours, postoperative 24 hours, and postoperative 72 hour.
Tumor Necrosis Factor-alpha (TNF-α), Interleukin-1 (IL-1), Interleukin-6 (IL-6): The concentrations of these pro-inflammatory cytokines will be measured in serum. Quantitative detection will be performed using specific, validated human ELISA kits. These cytokines are central mediators of the systemic inflammatory response; elevated levels post-surgery are associated with pain, tissue catabolism, and delayed recovery. The assay results will provide concentrations in picograms per milliliter (pg/mL).
Visual Analogue Scale (VAS) Pain Score
Time frame: Preoperative 24 hours, postoperative 24 hours, postoperative 72 hours, and postoperative 4 weeks
Assessment Method: Pain intensity will be subjectively assessed by the patient using a 100-mm horizontal line Visual Analogue Scale. The left endpoint (0 mm) is labeled "No pain," and the right endpoint (100 mm) is labeled "Worst imaginable pain." Patients will be instructed to mark a point on the line that best represents their pain intensity at that moment. Scoring: The distance from the "No pain" endpoint to the patient's mark is measured in millimeters, providing a score from 0 to 100. A higher score indicates greater pain intensity.
American Knee Society (AKS) Score
Time frame: Preoperative 24 hours, postoperative 24 hours, postoperative 72 hours, and postoperative 4 weeks.
Assessment Components: The AKS Score is a physician-administered assessment comprising two separate sub-scores: Knee Score (0-100 points): Evaluates the knee joint itself, focusing on pain (50 points), stability (25 points), and range of motion (25 points), while deducting points for flexion contracture, extension lag, and malalignment. Function Score (0-100 points): Evaluates the patient's functional ability, assessing walking distance (50 points) and stair climbing (50 points). The use of walking aids leads to point deductions. Criteria and Definition: A higher total score indicates better knee function and less impairment. The assessment will be performed by a trained orthopedic surgeon or research nurse through patient interview and physical examination. Specific criteria for pain levels, range of motion measurement using a goniometer, ligament stability tests, and observation of gait and stair navigation will be applied strictly according to the official AKS guidelines.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Rosa roxburghii in people with Osteoarthritis, run by Shuguang Gao.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yumei Wu, BS (+86 15073738546, 2648565027@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxidative Stress Markers (time frame: Preoperative 24 hours, postoperative 24 hours, postoperative 72 hours, and postoperative 4 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.