跳至主要内容
临床试验/EUCTR2020-001071-33-NL
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

研究者

发起方
BirrBeheerBV

相似试验

eaking of bacterial products from the intestine into... | 临床试验