Effects of Botanical Microglia Modulators in Gulf War Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change From Baseline in Overall Gulf War Illness Disease Severity
研究概览
简要总结
The overall objective of this protocol is to test if Gulf War Illness (GWI) involves chronic inflammation that cannot be measured with typical techniques. The investigators will be observing the effects of nine different botanical compounds (supplements) that are known to suppress inflammation. If one of those supplements helps the symptoms of GWI, it will give the investigators information about what is wrong in people with GWI.
详细描述
There is still a poor understanding of the pain, fatigue, and other symptoms that affect approximately 250,000 veterans. The precise mechanism of Gulf War Illness (GWI) is not understood, and there is no targeted treatment for the condition. A current model for GWI points to the central nervous system, immune cells, called microglia that may be hyperactive in patients with GWI. Discovering effective treatments for this disorder is a top priority of GWI research.
Given the investigator's preliminary data, it is suspected that GWI is a form of low-level neuroinflammation that involves hypersensitivity of receptors on microglia. In order to help test that hypothesis, the investigators will be administering supplements that have been shown in vitro or animal in vivo to suppress microglia function in a way that is anti-inflammatory and neuroprotective. If any of these agents suppress symptoms in GWI, it will give the investigators important information about the disease that may allow for creation of better diagnostic tools and treatments in future research studies. Observing the effects of the selected nine anti-inflammatory botanical compounds, in this clinical study, is a strong compliment to the ongoing mechanistic GWI research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 39 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 39-65, inclusive
- •Veterans who meet the Kansas inclusion criteria for GWI
- •Present in Persian Gulf between 1990 and August 1991
- •Patient completes daily report during 2 week baseline period (at least 80% completion rate)
- •Able to receive a venous blood draw
排除标准
- •Positive rheumatoid factor at screening
- •Positive anti-nuclear antibody at screening
- •C-reactive protein> 3mg/L at screening
- •Erythrocyte Sedimentation Rate> 40mm/hr at screening
- •Auto-immune disorder
- •Diagnosed Rheumatologic Condition
- •Major PTSD symptoms
- •Hypotension (under 90/60 mm Hg) or history of cardiovascular disease
- •Antihypertensive, anticoagulant medication, nitroglycerine, lithium medication use
- •Diabetes with Hemoglobin A1C >9%
- •History of anaphylaxis to study botanical compounds
- •Current daily use of opioid medication
- •Hospital Anxiety and Depression Scale, Depression subscale score of 16 or higher at baseline
- •Current litigation of worker's compensation claim
- •Blood or clotting disorder
- •Acute infection (body temperature over 100 degrees F)
- •Current daily use of confounding-anti-inflammatory medication as part of regular medication regimen
- •Individuals that are not able to read & understand English
研究组 & 干预措施
Epimedium
1000-2000mg in capsule form by mouth every day
干预措施: Epimedium (Dietary Supplement)
Nettle
435-1305mg in capsule form by mouth every day
干预措施: Nettle (Dietary Supplement)
Reishi Mushroom
1600-3200mg in capsule form by mouth every day
干预措施: Reishi Mushroom (Dietary Supplement)
Placebo
in capsule form by mouth every day
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change From Baseline in Overall Gulf War Illness Disease Severity
时间窗: Week 17
Self reported Gulf War Illness symptom severity evening reports were collected for the duration of the study. Scale= change from baseline in overall GWI Disease severity (-100 to +100, with positive numbers indicating how much the symptom improved).
次要结局
- Change From Baseline in Pain Severity(Week 17)
- Change From Baseline in Fatigue Severity(Week 17)
- Change From Baseline in Cognitive Symptom Severity(Week 17)
- Change From Baseline in Respiratory Symptom Severity(Week 17)
- Change From Baseline in Mood Symptom Severity(Week 17)
- Change From Baseline in Dermatological Symptom Severity(Week 17)
- Change From Baseline in Gastrointestinal Symptom Severity(Week 17)
研究者
Jarred Younger
Associate Professor
University of Alabama at Birmingham