NCT04506411已完成不适用
Placebo Controlled Randomized Clinical Trial to Evaluate Efficacy of Turmipure Gold® to Improve Joint Function in Subjects With Distinct Kellgren-Lawrence Knee Radiographic Scores
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 8
- 主要终点
- Change in WOMAC™ Pain
研究概览
简要总结
The objective of the study is to test the capacity of a 12-weeks Turmipure GOLD® supplementation to reduce joint discomfort.
详细描述
The aim of this clinical study is to determine whether oral administration of Turmipure GOLD® can contribute to the improvement of mobility and joint function in adult population with knee discomfort and with distinct Kellgren-Lawrence (K&L) knee radiographic scores.
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
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consent to the study and to comply with study product
- •Who have a BMI between 18 and 32 kg/m²
- •Who has mild to moderate knee pain for at least 3 months before enrollment (VAS between 40 to 70 on 100mm scale after respecting a washout period depending on the half-life of the excluded medications)
- •Who has radiographic evidence of Kellgren-Lawrence score 0, 1, 2 and 3 in the tibio-femoral compartment of the target knee
- •Who is able to perform the physical performance-based tests and understands all questions from the WOMAC questionnaire
- •Who is willing to refrain from taking any pain reliever (OTC or prescription) and other pharmacological, nutritional agent (e.g. glucosamine), device or therapy (e.g. acupuncture) which may influence the study outcome during the entire trial (other than determined authorized rescue medication)
- •Who is willing to not change dietary habits, level of physical activity (including any heavy physical work with high loading of the knee joints) and body weight
排除标准
- •Subjects with any clinically significant levels of the safety parameters at screening
- •Pregnant or lactating females, or wishing to become pregnant during the study
- •Subject with joint pain related to some predisposing conditions that have adversely altered the joint tissues often due to a specific cause
- •Subject with Kellgren-Lawrence grade 4 in the tibio-femoral compartment of the target knee
- •Who has clinically apparent tense effusion of the target knee or other joint
- •Who has/had viscosupplementation in any joint including the target knee or other joint within 6 months prior to screening
- •Who has concomitant inflammatory disease or other condition that affects the joints deemed exclusionary by the Principal Investigator (e.g. rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis and active infection, etc...)
- •Who has symptomatic osteoarthritis of the contralateral knee that is not responsive to paracetamol and requires other therapy
- •Who is taking any treatment/supplementation which may interfere with study conduct and interpretation of study results (4-weeks washout, e.g. glucosamine, chondroitin, corticosteroids) except calcium and vitamin D supplements
- •Who is under any medical condition deemed exclusionary by the Principal Investigator
- •Subject has a history of drug and / or alcohol abuse at the time of enrollment
- •Change of dietary habit within the preceding month
- •Subject with known organic disease, including an inflammatory bowel disease, a benign or malign tumor of intestine or colon and significant systemic disease
- •Subject currently involved in any other clinical trial or having participated in a trial within the preceding 90 days
- •Subject with known allergy to components of the test product
- •Subject has any concurrent medical or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements
- •History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years
- •Significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would preclude supplement ingestion and/or assessment of safety and the study objectives
- •Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation/severe, difficulty swallowing)
- •Who is taking any anticoagulant or heparin treatment
结局指标
主要结局
Change in WOMAC™ Pain
时间窗: 12-weeks
Knee joint pain discomfort assessed with the validated Western Ontario and McMaster University questionnaire (WOMAC) using its visual analogue scale version (VAS). The WOMAC VA 3.1 Pain subscore (WOMAC A) ranges from 0 to 100 mm (averaging five VAS 0-100 mm) with higher scores indicating more pain.
次要结局
- Stair Climb Physical Performance(12-weeks)
- Clinical Global Impression of Change (CGIC)(12-weeks)
- Assessment of use of rescue medicine(12-weeks)
- Change in WOMAC™ Physical function(12-weeks)
- Pain intensity at rest(12-weeks)
- "Patient Global Assessment" (PGA)(12-weeks)
- Quality of Life evaluation(12-weeks)
- Change in WOMAC™ Stiffness(12-weeks)
- OMERACT-OARSI criteria(12-weeks)
- 30s Chair Stand Physical Performance(12-weeks)
- Change in WOMAC™ Global Index(12-weeks)
- Pain intensity while walking(12-weeks)
- 40m Fast-paced Walked Physical Performance(12-weeks)
- Time up & Go Physical Performance(12-weeks)
研究者
研究点 (8)
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