EUCTR2013-005466-19-NL进行中（未招募）1 期
Cytokine inhibition in Chronic Fatigue Syndrome patients - a pilot study. - CiCFS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- RadboudUMC
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
- Female
入选标准
- •In order to be eligible to participate in this study, a subject must meet
- •all of the following criteria:
- •CDC-diagnosed CFS-patients;
- •female, between 18 and 59 years old;
- •score of >40 on the subscale fatigue severity of the CIS (Checklist
- •Individual Strength);
- •marked functional impairment assessed with the Sickness Impact
- •Profile (SIP-8) and operationalised as a total score of > 800.
- •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 46
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A potential subject who meets any of the following criteria will be
- •excluded from participation in this study:
- •pregnant or nursing women;
- •women who intend to get pregnant during the study;
- •patients who use or have used psychotropic medication in the past
- •substance abuse in the past 3 months;
- •patients taking any medication except oral contraceptives and/or
- •paracetamol;
- •patients with evident somatic co-morbidity;
- •previous or current engagement in CFS research;
- •inability to understand the nature and the extent of the trial and the
- •procedure required;
- •psychiatric co-morbidity assessed with the MINI;
- •any condition, which in the opinion of the investigators might
- •interfere with the evaluation of the study objects;
- •current engagement in a legal procedure.
研究者
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