OsteoarthritisNCT06535204
Effects of Anthriscus Sylvestris Leaves on Mild Knee Osteoarthritis
A study testing Aqueous extract of A. sylvestris leaves and microcrystalline cellulose in people with Osteoarthritis and Articular Cartilage, run by Pusan National University Hospital at 1 site in South Korea.
Trial summary
Osteoarthritis (OA) is a common degenerative joint disorder that causes pain, stiffness, and functional impairment. Current treatments for OA are limited to symptom relief and have potential side effects. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Articular Cartilage, Functional Food
- What is being tested?
- Aqueous extract of A. sylvestris leaves and microcrystalline cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jun 2019to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 40 to 75 years, regardless of gender
- Individuals with a Visual Analogue Scale (VAS) score of 3/10 or higher
- Individuals with a Kellgren \& Lawrence grading scale of grade 1 or 2, determined by 'Both Knee Joint AP/LAT' radiographs
- Individuals who have had a washout period of at least 4 weeks for arthritis- related medications or health supplements
- Individuals capable of normal physical activity who have voluntarily provided written informed consent to participate in this study
Who cannot join
- Individuals with a history of fractures within the past year
- Individuals with osteophytes around the joints, irregular joint surfaces, or subchondral bone cysts, indicating moderate arthritis
- Individuals currently undergoing treatment for a diagnosed thyroid disorder
- Individuals with kidney disease or serum creatinine levels of 1.4 mg/dL or higher
- Individuals with proteinuria of 2+ or higher
- Individuals with liver disease or AST or ALT levels of 100 IU/L or higher
Show all 17Show fewer
- Individuals with uncontrolled hypertension or heart conditions such as angina or myocardial infarction
- Individuals taking medication for psychiatric disorders, except for intermittent medication for sleep disorders
- Individuals who have taken herbal or medicinal decoctions within the past two months
- Individuals who have received other investigational drugs within the past four weeks
- Individuals who need to continuously take medication that may affect the outcome of the study
- Individuals with a history of gastrointestinal resection surgery (excluding appendectomy)
- Pregnant or breastfeeding women
- Individuals with alcoholism or those who drink more than four times per week regularly
- Individuals with hypersensitivity to the test food or its ingredients
- Individuals who may be uncooperative or deemed incapable of completing the study by the investigator
- Individuals with arthritis due to specific factors other than degeneration, as determined by the principal investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Oral Administration of Anthriscus Sylvestris Leaves on Mild Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Osteoarthritis (OA) is a common degenerative joint disorder that causes pain, stiffness, and functional impairment. Current treatments for OA are limited to symptom relief and have potential side effects. Anthriscus sylvestris leaves are a natural remedy that has been shown to have anti-inflammatory and cartilage-protective effects in animal models of OA.
Read the detailed description
Osteoarthritis (OA) is a common degenerative joint disorder that causes pain, stiffness, and functional impairment. Current treatments for OA are limited to symptom relief and have potential side effects. Anthriscus sylvestris leaves are a natural remedy that has been shown to have anti-inflammatory and cartilage-protective effects in animal models of OA. A randomized, double-blind, placebo-controlled trial was conducted with 100 participants aged 40 to 75 with Kellgren \& Lawrence grade 1 or 2 knee OA. Participants were assigned to receive either 500 mg of Anthriscus sylvestris leaves extract or placebo daily for 12 weeks. The primary outcome was the change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score from baseline to week 12. Secondary outcomes included the changes in visual analogue scale (VAS) for pain, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) from baseline to week 12. The Anthriscus sylvestris leaves extract group showed a significant improvement in the total WOMAC score, as well as the pain, stiffness, and physical function sub-scores, compared with the placebo group after 12 weeks of treatment. The Anthriscus sylvestris leaves extract group also showed a significant reduction in VAS and CRP, but not in ESR, compared with the placebo group. No adverse events or safety concerns were reported in either group. Anthriscus sylvestris leaves extract enhanced joint and cartilage health in humans with mild OA symptoms, as indicated by the reduction in WOMAC, VAS, and CRP. The extract was also safe and well-tolerated. Anthriscus sylvestris leaves extract may be a promising natural alternative for the management and prevention of OA.
- Conditions
- Osteoarthritis, Articular Cartilage, Functional Food
- Being tested
- Aqueous extract of A. sylvestris leaves, microcrystalline cellulose
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aqueous extract of A. sylvestris leavesDietary supplement
Provided functional food made from Aqueous extract of A. sylvestris leaves
microcrystalline celluloseDietary supplement
Provided placebo composed of microcrystalline cellulose instead of A. sylvestris leaf extract.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The intervention group consumed the test food twice daily (400 mg in the morning and 400 mg in the evening, each time as one hard capsule), 30 minutes after eating, with water. The administration period lasted 12 weeks for each participant.
The test food is named Aqueous extract of A. sylvestris leaves. The ingredients and their contents are as follows: Aqueous extract of A. sylvestris leaves 62.5%, Microcrystalline Cellulose 35.5%, Silicon Dioxide 1.0%, Magnesium Stearate 1.0%. The dosage form is a hard capsule, with a content weight of 400 mg per capsule. Receives: Dietary Supplement: Aqueous extract of A. sylvestris leaves |
| Control Group | Placebo comparator | The Control group consumed the test food twice daily (400 mg in the morning and 400 mg in the evening, each time as one hard capsule), 30 minutes after eating, with water. The administration period lasted 12 weeks for each participant.
The test food is named Microcrystalline Cellulose. The ingredients and their contents are as follows: Microcrystalline Cellulose 98%, Silicon dioxide 1.0%, Magnesium stearate 1.0%. The dosage form is a hard capsule, with a content weight of 400 mg per capsule. Receives: Dietary Supplement: microcrystalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC(Western Ontario and Mcmasters Universities)
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) was assessed through a survey, with scores ranging from 0 to 96. Higher scores indicate worse outcomes.
Measured: Visit 2 (baseline) and Visit 3 (during the trial, 4week±7day) and Visit 4 (end of the trial) (12week±7day)
Secondary outcomes (2)
VAS(Visual Analogue Scale)
The Visual Analogue Scale (VAS) was assessed through a survey, with scores ranging from 0 to 100. Higher scores indicate worse outcomes.
Measured: Visit 2 (baseline) and Visit 3 (during the trial, 4week±7day) and Visit 4 (end of the trial) (12week±7day)
Anti-inflammatory indicator
Concentration of C-Reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR) were measured from blood samples collected from the Jeonju vein after fasting for 8 hours and analyzed in our hospital's laboratory.
Measured: Visit 1 (screening) and Visit 3 (during the trial, 4week±7day) and Visit 4 (end of the trial) (12week±7day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start24 Jun 2019
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535204
- Sponsor's protocol ID
- H-1905-043-079
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Administration of Anthriscus Sylvestris Leaves on Mild Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06535204
- Acronym / sponsor ID
- H-1905-043-079
- Conditions
- Osteoarthritis, Articular Cartilage, Functional Food
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 2 Aug 2024 (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.
Osteoarthritis (OA) is a common degenerative joint disorder that causes pain, stiffness, and functional impairment. Current treatments for OA are limited to symptom relief and have potential side effects. Anthriscus sylvestris leaves are a natural remedy that has been shown to have anti-inflammatory and cartilage-protective effects in animal models of OA.
Detailed description
Osteoarthritis (OA) is a common degenerative joint disorder that causes pain, stiffness, and functional impairment. Current treatments for OA are limited to symptom relief and have potential side effects. Anthriscus sylvestris leaves are a natural remedy that has been shown to have anti-inflammatory and cartilage-protective effects in animal models of OA. A randomized, double-blind, placebo-controlled trial was conducted with 100 participants aged 40 to 75 with Kellgren \& Lawrence grade 1 or 2 knee OA. Participants were assigned to receive either 500 mg of Anthriscus sylvestris leaves extract or placebo daily for 12 weeks. The primary outcome was the change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score from baseline to week 12. Secondary outcomes included the changes in visual analogue scale (VAS) for pain, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) from baseline to week 12. The Anthriscus sylvestris leaves extract group showed a significant improvement in the total WOMAC score, as well as the pain, stiffness, and physical function sub-scores, compared with the placebo group after 12 weeks of treatment. The Anthriscus sylvestris leaves extract group also showed a significant reduction in VAS and CRP, but not in ESR, compared with the placebo group. No adverse events or safety concerns were reported in either group. Anthriscus sylvestris leaves extract enhanced joint and cartilage health in humans with mild OA symptoms, as indicated by the reduction in WOMAC, VAS, and CRP. The extract was also safe and well-tolerated. Anthriscus sylvestris leaves extract may be a promising natural alternative for the management and prevention of OA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Dietary Supplement: Aqueous extract of A. sylvestris leavesThe intervention group consumed the test food twice daily (400 mg in the morning and 400 mg in the evening, each time as one hard capsule), 30 minutes after eating, with water. The administration period lasted 12 weeks for each participant. The test food is named Aqueous extract of A. sylvestris leaves. The ingredients and their contents are as follows: Aqueous extract of A. sylvestris leaves 62.5%, Microcrystalline Cellulose 35.5%, Silicon Dioxide 1.0%, Magnesium Stearate 1.0%. The dosage form is a hard capsule, with a content weight of 400 mg per capsule. |
| Control Group | Placebo comparator | Dietary Supplement: microcrystalline celluloseThe Control group consumed the test food twice daily (400 mg in the morning and 400 mg in the evening, each time as one hard capsule), 30 minutes after eating, with water. The administration period lasted 12 weeks for each participant. The test food is named Microcrystalline Cellulose. The ingredients and their contents are as follows: Microcrystalline Cellulose 98%, Silicon dioxide 1.0%, Magnesium stearate 1.0%. The dosage form is a hard capsule, with a content weight of 400 mg per capsule. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 40 to 75 years, regardless of gender
- Individuals with a Visual Analogue Scale (VAS) score of 3/10 or higher
- Individuals with a Kellgren \& Lawrence grading scale of grade 1 or 2, determined by 'Both Knee Joint AP/LAT' radiographs
- Individuals who have had a washout period of at least 4 weeks for arthritis- related medications or health supplements
- Individuals capable of normal physical activity who have voluntarily provided written informed consent to participate in this study
Key exclusion criteria (17 listed)
- Individuals with a history of fractures within the past year
- Individuals with osteophytes around the joints, irregular joint surfaces, or subchondral bone cysts, indicating moderate arthritis
- Individuals currently undergoing treatment for a diagnosed thyroid disorder
- Individuals with kidney disease or serum creatinine levels of 1.4 mg/dL or higher
- Individuals with proteinuria of 2+ or higher
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 |
|---|---|---|
| Aqueous extract of A. sylvestris leavesProvided functional food made from Aqueous extract of A. sylvestris leaves | Dietary supplement | Experimental Group |
| microcrystalline celluloseProvided placebo composed of microcrystalline cellulose instead of A. sylvestris leaf extract. | Dietary supplement | Control Group |
Primary outcome
WOMAC(Western Ontario and Mcmasters Universities)
Time frame: Visit 2 (baseline) and Visit 3 (during the trial, 4week±7day) and Visit 4 (end of the trial) (12week±7day)
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) was assessed through a survey, with scores ranging from 0 to 96. Higher scores indicate worse outcomes.
2 secondary outcomes
VAS(Visual Analogue Scale)
Time frame: Visit 2 (baseline) and Visit 3 (during the trial, 4week±7day) and Visit 4 (end of the trial) (12week±7day)
Anti-inflammatory indicator
Time frame: Visit 1 (screening) and Visit 3 (during the trial, 4week±7day) and Visit 4 (end of the trial) (12week±7day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aqueous extract of A. sylvestris leaves and microcrystalline cellulose in people with Osteoarthritis and Articular Cartilage, run by Pusan National University Hospital at 1 site in South Korea.
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 5 inclusion and 17 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: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC(Western Ontario and Mcmasters Universities) (time frame: Visit 2 (baseline) and Visit 3 (during the trial, 4week±7day) and Visit 4 (end of the trial) (12week±7day)). 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 2 Aug 2024.