Clinical trial NCT06535204: Effects of Anthriscus Sylvestris Leaves on Mild Knee Osteoarthritis
Official title: Effects of Oral Administration of Anthriscus Sylvestris Leaves on Mild Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Articular Cartilage
Functional Food
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: WOMAC(Western Ontario and Mcmasters Universities)
timeFrame: Visit 2 (baseline) and Visit 3 (during the trial, 4week±7day) and Visit 4 (end of the trial) (12week±7day)
Secondary outcomes:
measure: VAS(Visual Analogue Scale)
timeFrame: Visit 2 (baseline) and Visit 3 (during the trial, 4week±7day) and Visit 4 (end of the trial) (12week±7day)
measure: Anti-inflammatory indicator
timeFrame: Visit 1 (screening) and Visit 3 (during the trial, 4week±7day) and Visit 4 (end of the trial) (12week±7day)
Other outcomes:
measure: Blood pressure
timeFrame: Visit 1 (screening) Visit 2 (baseline) and Visit 3 (during the trial, 4week±7day) and Visit 4 (end of the trial) (12week±7day)
measure: Body weight
timeFrame: Visit 1 (screening)
measure: Height
timeFrame: Visit 1 (screening)
measure: Gathering subject information from the survey
timeFrame: Visit 1 (screening)
measure: Assessment of Bilateral Knee Joint Degeneration using AP/LAT Radiographs
timeFrame: Visit 1 (screening)
measure: Presence of Hepatitis B Surface Antigen (HbsAg)
timeFrame: Visit 1 (screening)
measure: Presence of Hepatitis C Virus Antibodies (Anti-HCV)
timeFrame: Visit 1 (screening)
measure: Presence of Human Chorionic Gonadotropin (HCG) in Urine
timeFrame: Visit 1 (screening)
measure: Blood Glucose Level
timeFrame: Visit 1 (screening) and Visit 3 (during the trial, 4week±7day) Visit 4 (end of the trial) (12week±7day)
measure: Complete Blood Count (CBC)
timeFrame: Visit 1 (screening) and Visit 3 (during the trial, 4week±7day) Visit 4 (end of the trial) (12week±7day)
measure: Blood Urea Nitrogen (BUN) Level
timeFrame: Visit 1 (screening) and Visit 3 (during the trial, 4week±7day) Visit 4 (end of the trial) (12week±7day)
measure: Serum Creatinine Level
timeFrame: Visit 1 (screening) and Visit 3 (during the trial, 4week±7day) Visit 4 (end of the trial) (12week±7day)
measure: Estimated Glomerular Filtration Rate (GFR)
timeFrame: Visit 1 (screening) and Visit 3 (during the trial, 4week±7day) Visit 4 (end of the trial) (12week±7day)
measure: Total Cholesterol Level
timeFrame: Visit 1 (screening) and Visit 3 (during the trial, 4week±7day) Visit 4 (end of the trial) (12week±7day)
measure: Urine pH
timeFrame: Visit 1 (screening)
measure: Urine Specific Gravity
timeFrame: Visit 1 (screening)
measure: Urine Protein
timeFrame: Visit 1 (screening)
measure: Urine Glucose
timeFrame: Visit 1 (screening)
measure: Urine Ketones
timeFrame: Visit 1 (screening)
measure: Urine Blood
timeFrame: Visit 1 (screening)
measure: Urine Leukocytes
timeFrame: Visit 1 (screening)
measure: Aspartate Aminotransferase (AST)
timeFrame: Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)
measure: Alanine Aminotransferase (ALT)
timeFrame: Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)
measure: Alkaline Phosphatase (ALP)
timeFrame: Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)
measure: Gamma-Glutamyl Transferase (GGT)
timeFrame: Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)
measure: Total Bilirubin
timeFrame: Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)
measure: Serum Sodium (Na)
timeFrame: Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)
measure: Serum Potassium (K)
timeFrame: Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)
measure: Serum Chloride (Cl)
timeFrame: Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)
measure: C-Reactive Protein (CRP)
timeFrame: Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)
measure: Triglycerides
timeFrame: Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)
measure: High-Density Lipoprotein (HDL)
timeFrame: Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)
measure: Low-Density Lipoprotein (LDL)
timeFrame: Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
state: Seo-gu
Study officials:
References: