EUCTR2020-001071-33-NL进行中(未招募)1 期
Role of the intestine on osteoarthritis of the hand and the effect of Sustained Release Calcium Butyrate. - Intestine and osteoarthritis
BirrBeheerBV0 个研究点目标入组 33 人开始时间: 2021年12月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Age = 50 year and = 75 years,
- •-Osteoarthritis of the hand according to the 1990 ACR diagnostic criteria for hand OA (Altman 1990) in both hands operationalized as:
- •Hand pain, aching, or stifness and 3 or 4 of the following:
- •Hard tissue enlargement of 2 or more of 10 selected joints
- •Hard tissue enlargement of 2 or more DIP joints
- •Fewer than 3 swollen MCP joints
- •Deformity of at least 1 of 10 selected joints.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 33
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 33
排除标准
- •-Recent use of antibiotics (last three months)
- •-Previous surgery of one of the hands
- •-Recent cerebro- or cardiovascular incident (past 6 months)
- •-Other chronic inflammatory disease
- •-Other musculoskeletal diseases than OA with possible hand localisation
- •-Cognitive deficits affecting the scoring process
- •-Received intramuscular of intra-articular corticosteroid injections in the previous 4 weeks
- •-Fibromyalgia according to the 2010 ACR diagnostic criteria for fibromyalgia (Wolfe 2011)
- •-Any other syndrome(s) or condition(s) that could interfere with the assessment of pain
- •-Severe current psychiatric disorders assessed by physician
- •-Self-reported consumption of alcoholic drinks, > 2 units per day
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