跳至主要内容
临床试验/NCT06535204
NCT06535204已完成不适用

Effects of Oral Administration of Anthriscus Sylvestris Leaves on Mild Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Pusan National University Hospital2 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2019年6月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
WOMAC(Western Ontario and Mcmasters Universities)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

WOMAC(Western Ontario and Mcmasters Universities)

时间窗: 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.

次要结局

  • Anti-inflammatory indicator(Visit 1 (screening) and Visit 3 (during the trial, 4week±7day) and Visit 4 (end of the trial) (12week±7day))
  • VAS(Visual Analogue Scale)(Visit 2 (baseline) and Visit 3 (during the trial, 4week±7day) and Visit 4 (end of the trial) (12week±7day))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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