Effects of Anthriscus Sylvestris Leaves on Mild Knee Osteoarthritis

Pusan National University Hospital100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

100

Conditions

Osteoarthritis Articular Cartilage Functional Food

Interventions

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

Locations (1)

Pusan National University Hospital

Busan, Seo-gu, South Korea

Outcomes

Primary Outcomes

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.

Time frame: Visit 2 (baseline) and Visit 3 (during the trial, 4week±7day) and Visit 4 (end of the trial) (12week±7day)

Secondary Outcomes

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.

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

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.

Time frame: Visit 1 (screening) and Visit 3 (during the trial, 4week±7day) and Visit 4 (end of the trial) (12week±7day)

Data from ClinicalTrials.gov

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