NCT04765189已完成不适用
Evaluation of the Efficacy of Mangoselect®, a Mangosteen Extract, and of a Formulation Containing Mangoselect®, in Subjects Suffering From Activity/Exercise-induced Knee Joint Discomfort During a 12-week Supplementation Period. A Double-blind, Randomized, Multi-arm, Parallel and Placebo-controlled Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Fytexia
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Change in knee joint subjective pain rating using a VAS (Visual Analog Scale) 0-10 cm
研究概览
简要总结
The aim of the present investigation is to evaluate the efficacy of Mangoselect®, a mangosteen extract, and of a formulation containing Mangoselect®, in subjects suffering from activity/exercise-induced knee joint pain/discomfort, during a 12-week supplementation period. Subjective discomfort improvement will be assessed with both WOMAC questionnaire and pain Visual Analogic Scale (VAS); functional joints features, quality of life, and inflammatory markers, will also be assessed. Finally, long lasting benefits will additionally be evaluated 4 weeks after the end of the supplementation period. The design of the study is double-blind, randomized, multi-arm, parallel and placebo controlled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physically active volunteers
- •BMI 22-29.9 kg/m2
- •Declaring knee joint pain during and/or after activity/exercise
- •Joint knee pain rated of at least 4 cm on a 10 cm VAS following activity/exercise
- •Diagnosed osteoarthritis grade I or II according to Kellgren-Lawrence classification
排除标准
- •Diagnosed inflammatory joint disorder or osteoarthritis grade III or more according to Kellgren-Lawrence classification
- •Currentlu chronically taking pain killer drugs or dietary supplement or intra-articular treatment 3 months before selection
- •Subjects with knee/joint surgery/replacement in the past 10 years
- •Significant injury of the studied knee joint 12 months before selection
- •Unable to carry out functional tests and/or questionnaires
- •Currently participating or having participated in another clinical trial in the 3 previous months
- •Pregnant women and women positive at Beta-HCG serology test
- •Any condition that the investigator believes would interfere with the ability to provide inform consent, or comply with study instructions, or confound the interpretations of the study results, or put the volunteer at undue risk
- •Allergy to one of the component of the supplements
结局指标
主要结局
Change in knee joint subjective pain rating using a VAS (Visual Analog Scale) 0-10 cm
时间窗: 12 weeks
Change in knee joint pain subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire
时间窗: 12 weeks
次要结局
- Change in knee joint stifness subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire(12 weeks)
- Change in knee mobility assessed with ROM (Range of Motion) assessment(12 weeks)
- Change in inflammatory status assessed with TNF-alpha plasma concentration(12 weeks)
- Change in knee joint physical functionning subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire(12 weeks)
- Change in muscular strength assessed with isokinetic strength measurment(12 weeks)
- Change in inflammatory status assessed with TNF-alpha receptor R1 plasma concentration(12 weeks)
- Change in inflammatory status assessed with IL-1beta plasma concentration(12 weeks)
- Change in inflammatory status assessed with TNF-alpha receptor R2 plasma concentration(12 weeks)
- Change in quality of life assessed with SF-12 questionnaire(12 weeks)
- Change in pain killer drug consumption assessed with daily diary(12 weeks)
- Change in inflammatory status assessed with IL-1beta receptor p68 plasma concentration(12 weeks)
- Change in inflammatory status assessed with IL-1beta receptor p80 plasma concentration(12 weeks)
研究者
研究点 (1)
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