Beyond Benefits of Q10: Mitochondrial Cocktail for Gulf War Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 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. placebo
研究概览
简要总结
The purpose of this study is to develop preliminary evidence, such as effect size and variance estimates, to guide successful conduct of a properly-powered clinical trial to assess the benefit of a mitochondrial cocktail (incorporating individualization of treatment) in Gulf War illness (GWI).
详细描述
See below.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 48 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet symptom criteria for Gulf War illness with BOTH the Centers for Disease Control and Prevention (CDC) Criteria (persistent symptoms in at least 2 of 3 designated symptom domains of fatigue/sleep, mood/cognition, and musculoskeletal) and Kansas Criteria (score a moderate or severe rating in at least 3 of the 6 symptom domains of fatigue, pain, neurological/cognitive/mood, skin, GI and respiratory).
排除标准
- •Have conditions like multiple sclerosis or lupus that can produce similar symptoms and be confused for Gulf War illness.
- •Participating in a concurrent treatment trial.
- •Unwilling or unable to comply with the treatment protocol
- •Failed run-in; do not take at least 80% of run-in medications
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. placebo
时间窗: 0, 3, 6 months (double-blind phase)
Mean change in single item General Self-Rated Health Visual Analog Scale from baseline
时间窗: 0, 3, 6 months (double-blind phase)
Percent improved on Gulf War Illness Modified Lower Extremity Performance Score/timed chair rises
时间窗: 6 months (double-blind phase)
Mean change of CoQ10 and Vitamin E levels, comparing active treatment to placebo
时间窗: 6 months (double-blind phase)
次要结局
- Assessment of summed symptom score (sum of ratings for UCSD GWI symptom index)(6, 9, 12 months)
研究者
Beatrice Golomb
Professor of Medicine
University of California, San Diego