NCT01909037已完成早期 1 期
Exploratory Non Comparative Study to Evaluate the Efficacy of Highly Bioavailable Curcumin (Flexofytol) in Patients With Knee Osteoarthritis
Tilman S.A.2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2012年3月1日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Serum levels of biomarkers of cartilage metabolism and inflammation
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of bio-optimized curcumin(Flexofytol) during a 90-days period in knee ostearthritis patients on the serum levels of specific biomarkers of osteoarthritis and on the evaluation of pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •45 to 80 years of age
- •Internal femorotibial gonarthrosis responding to the clinical and radiological criteria of ACR
- •Symptomatic knee for more than 6 months
- •Mean knee pain on the last 24 hours of at least 40 mm on VAS
- •Kellgren & Laurence grade II to III
- •Patients able to avoid NSAIDs and analgesics during the study
- •Patients having signed informed consent
- •Patients able to follow the study instructions
排除标准
- •Related to the osteoarthritis pathology:
- •Osteoarthritis linked to a metabolic arthropathy
- •Predominant associated symptomatic femoropatellar osteoarthritis
- •Chondromatosis or villonodular synovitis of the knee
- •Recent trauma (< 1 month) of the knee responsible for the pain
- •Inflammatory flare
- •Pathology potentially interfering with the evaluation (metabolic inflammatory arthropathy, rheumatoid arthritis, lower limb radiculalgia, arthritis...
- •Paget disease
- •Homolateral coxarthrosis
- •Articular Prosthesis
- •Knee joint effusion
- •Related to previous and associated treatments:
- •Corticosteroids injection in the previous month, whatever the joint concerned,
- •Hyaluronan injection in the evaluated knee during the previous 6 months,
- •NSAID or analgesics in the 72 hours prior to inclusion
- •No modification of Slow-acting drugs for OA and/or dietary supplements taken within less than 6 months prior to the study(ex: chondroitin sulfate, diacerein, soy and avocado unsaponifiables, oxaceprol, granions de cuivre, glucosamine, phytotherapy for OA, homeopathy for OA...),
- •Anticoagulant (coumarinic) treatment and heparin
- •General corticotherapy,
- •Contraindication to paracetamol.
- •Related to associated pathologies:
- •Patient suffering from serious associated illness (liver failure, kidney failure, non-controlled cardiovascular diseases...)
- •Related to patients:
- •Pregnant or breastfeeding women
- •Pre-menopausal women with no contraception
- •Patients unable to write
- •Patients enrolled in a clinical trial in the previous 3 months
- •Patients under juristic protection or under guardianship.
结局指标
主要结局
Serum levels of biomarkers of cartilage metabolism and inflammation
时间窗: 84 days
Change from baseline of serum levels of biomarkers
次要结局
- Pain and the global patient assessment of disease activity using a Visual Analog Scale (VAS)(84 days)
研究者
研究点 (2)
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