Effects of Anthriscus Sylvestris Leaves on Mild Knee Osteoarthritis

NCT06535204 | Completed

• 1 other identifier: H-1905-043-079
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Articular Cartilage; Functional Food

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

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

• Anti-inflammatory indicator

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

Other Outcomes (34)

• Blood pressure

  Visit 1 (screening) Visit 2 (baseline) and Visit 3 (during the trial, 4week±7day) and Visit 4 (end of the trial) (12week±7day)

• Body weight

  Visit 1 (screening)

• Height

  Visit 1 (screening)

Study Arms (2)

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.

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.

Dietary Supplement: microcrystalline cellulose

Interventions

Aqueous extract of A. sylvestris leaves DIETARY_SUPPLEMENT

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

Experimental Group

microcrystalline cellulose DIETARY_SUPPLEMENT

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

Control Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Pusan National University Hospital

Busan, Seo-gu, 49241, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

microcrystalline cellulose

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: August 2, 2024
• Study Start: June 24, 2019
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: August 2, 2024

Record last verified: 2024-07

Locations

KR (1)