NCT06515184招募中3 期
Coenzyme Q10 for Gulf War Illness: A Replication Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Number of symptoms (out of 20 on the UCSD Symptom Score Survey) showing more favorable change (trend or effect) on active treatment vs. on placebo.
研究概览
简要总结
The purpose of this study is to assess whether a high quality preparation of ubiquinone (coenzyme Q10) benefits symptoms, function, and quality of life in veterans with Gulf War illness.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets both CDC and Kansas deployment and symptom inclusion criteria.
- •Does not have a disqualifying condition.
- •Able to travel to a local Quest facility for study blood draws.
- •Adequate internet access to allow ZoomPro visit participation and remote survey completion.
- •Health prior to the Gulf War rated as "very good" or "excellent" (to exclude persons who may have had other health conditions with different mechanisms as the cause of their symptoms).
- •Willing to defer initiation of discretionary treatments or supplements during the expected course of study participation.
排除标准
- •Participating in another clinical trial.
- •Still-evolving adverse effects following another medication or health condition, such as covid or fluoroquinolone use.
- •On Coumadin/ warfarin.
- •Unable to participate for the required duration of the study.
研究组 & 干预措施
CoQ10 Arm 2
Active Comparator
PharmaNord Ubiquinone 100mg/3x day
干预措施: PharmaNord Bio-Quinone Active CoQ10 Gold 100mg (Drug)
Placebo Arm
Placebo Comparator
Placebo (made by PharmaNord, matches active treatment)
干预措施: PharmaNord Placebo (Drug)
CoQ10 Arm 1
Active Comparator
PharmaNord Ubiquinone 100mg/1x day
干预措施: PharmaNord Bio-Quinone Active CoQ10 Gold 100mg (Drug)
结局指标
主要结局
Number of symptoms (out of 20 on the UCSD Symptom Score Survey) showing more favorable change (trend or effect) on active treatment vs. on placebo.
时间窗: 3.5 months
All outcomes are assessed as change from baseline.
次要结局
- Percent improved on timed chair rises from Gulf War Illness Modified Lower Extremity Summary Performance Score.(3.5 months)
- Mean change in single-item General Self-Rated Health (GSRH).(3.5 months)
- Individual GWI Symptoms(3.5, 7 months)
- Relation of change in time to do five chair rises to change in blood level of coenzyme Q10(3.5, 7 months)
- Effect of CoQ10 in the majority male subset on symptoms.(3.5, 7 months)
- Effect of CoQ10 in the majority male subset on timed chair rises.(3.5, 7 months)
- Effect of CoQ10 in the majority male subset on GSRH.(3.5, 7 months)
研究者
Beatrice Golomb
Professor of Medicine
University of California, San Diego
研究点 (2)
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