Effects of Anthriscus Sylvestris Leaves on Mild Knee Osteoarthritis

NCT ID: NCT06535204

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-24
• Study Completion Date: 2020-04-30

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.

Conditions

Osteoarthritis; Articular Cartilage; Functional Food

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental Group

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.

Group Type: EXPERIMENTAL

Aqueous extract of A. sylvestris leaves

Intervention Type: DIETARY_SUPPLEMENT

Provided functional food made from Aqueous extract of A. sylvestris leaves

Control Group

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.

Group Type: PLACEBO_COMPARATOR

microcrystalline cellulose

Intervention Type: DIETARY_SUPPLEMENT

Provided placebo composed of microcrystalline cellulose instead of A. sylvestris leaf extract.

Interventions

Aqueous extract of A. sylvestris leaves

Provided functional food made from Aqueous extract of A. sylvestris leaves

Intervention Type: DIETARY_SUPPLEMENT

microcrystalline cellulose

Provided placebo composed of microcrystalline cellulose instead of A. sylvestris leaf extract.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pusan National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pusan National University Hospital

Busan, Seo-gu, South Korea

Countries

South Korea

Other Identifiers

H-1905-043-079

Identifier Type: -

Identifier Source: org_study_id