NCT00992004已完成2 期
Comparative, Randomized, Double-blind, Placebo-controlled, Parallel Group Study, to Evaluate the Efficacy of a Turmeric Extract (Arantal®) Versus Placebo in Patients With Osteoarthritis of the Knee (Gonarthrosis).
Bioxtract SA2 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2009年6月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
研究概览
简要总结
The purpose of this study is to determine the efficacy and the tolerance on 15 days of a turmeric extract (Arantal®) on pain related to gonarthrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 40 through 80 years of age
- •Subject diagnosed with femorotibial osteoarthritis of the knee (diagnosed according to the clinical and radiologic criteria of ACR),
- •Patient's Assessment of Arthritis Pain measurement on the last 24 hours of at least 50 mm on VAS,
- •Patient has not received any NSAIDs within 72 hours and any analgesics within 24 hours,
- •Patients with chronic knee pain (i.e., knee pain at least every other day during the month preceding inclusion),
- •Patients with radiologic knee osteoarthritis (Kellgren-Lawrence grade 2-4, on radiography less than 12 months old),
- •Patients having signed the informed consent,
- •Patients capable of comprehend the study instructions.
排除标准
- •Related to the osteoarthritis pathology:
- •Osteoarthritis linked to a metabolic arthropathy: chondrocalcinosis already diagnosed or defined by calcium edging on at least one femorotibial joint space, gout...,
- •Predominant associated symptomatic femoropatellar osteoarthritis,
- •Chondromatosis or villonodular synovitis of the knee,
- •Recent trauma (< 1 month) of the knee responsible for the pain,
- •Knee joint effusion justifying an evacuation through puncturing,
- •Inflammatory flare (night pain, joint effusion) corresponding to a KOFUS score less than 7,
- •Pathology potentially interfering with the evaluation (metabolic inflammatory arthropathy, rheumatoid arthritis, lower limb radiculalgia, arthritis...),
- •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,
- •Patient who took NSAID in the 72 hours prior to inclusion or Analgesics in the 24 hours prior to inclusion,
- •Slow-acting drugs for OA and/or dietary supplements taken within less than 3 months prior to the study product administration or for which the dose has been modified in the last three months (ex: chondroitin sulfate, diacerein, soy and avocado unsaponifiables, oxaceprol, granions de cuivre, glucosamine, phytotherapy for OA, homeopathy for OA...),
- •Anticoagulant treatment without gastric protection,
- •General corticotherapy,
- •Contraindication to paracetamol.
- •Related to associated pathologies:
- •Patient suffering from serious associated illness (liver failure, kidney failure, non-controlled cardiovascular diseases...),
- •Peptic ulcer.
- •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
Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
时间窗: 15 days
次要结局
- Kinetics of the analgesic effect by a variance analysis in repeated measures (Likert Scale)(15 days)
研究者
研究点 (2)
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