- Change from baseline in overall Gulf War Illness disease severity [ Time Frame: Average disease severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline. ] [ Designated as safety issue: No ]
Self reported Gulf War Illness symptom severity reported twice daily, in the morning and evening, for the duration of the study. Single item scored 0-100 (0=no symptoms; 100=severe symptoms).
- Change from baseline in Pain Severity [ Time Frame: Average pain severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline. ] [ Designated as safety issue: No ]
Self reported pain severity reported twice daily, in the morning and evening, for the duration of the study. Single item scored 0-100 (0=no pain; 100=severe pain).
- Change from baseline in Fatigue Severity [ Time Frame: Average fatigue severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline. ] [ Designated as safety issue: No ]
Self reported fatigue severity reported twice daily, in the morning and evening, for the duration of the study. Single item scored 0-100 (0=not fatigued at all; 100=severely fatigued).
- Change from baseline in Cognitive Symptom Severity [ Time Frame: Average cognitive symptom severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline. ] [ Designated as safety issue: No ]
Self reported cognitive symptom severity reported twice daily, in the morning and evening, for the duration of the study. Single item scored 0-100 (0=not [able to think and remember] clearly at all; 100=[able to think and remember] very clearly).
- Change from baseline in Mood Symptom Severity [ Time Frame: Average mood severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline. ] [ Designated as safety issue: No ]
Self reported mood symptom severity reported twice daily, in the morning and evening, for the duration of the study. Single item scored 0-100 (0=not good [mood] at all; 100=extremely good [mood]).
- Change from baseline in Dermatological Symptom Severity [ Time Frame: Average dermatological symptom severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline. ] [ Designated as safety issue: No ]
Self reported dermatological symptom severity reported twice daily, in the morning and evening, for the duration of the study. Single item scored 0-100 (0=no skin problems at all; 100=severe skin problems).
- Change from baseline in Respiratory Symptom Severity [ Time Frame: Average respiratory symptom severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline. ] [ Designated as safety issue: No ]
Self reported respiratory symptom severity reported twice daily, in the morning and evening, for the duration of the study. Single item scored 0-100 (0=no breathing or respiratory problems at all; 100=severe breathing or respiratory problems).
- Change from baseline in Gastrointestinal Symptom Severity [ Time Frame: Average gastrointestinal symptom severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline. ] [ Designated as safety issue: No ]
Self reported gastrointestinal symptom severity reported twice daily, in the morning and evening, for the duration of the study. Single item scored 0-100 (0=no bowel or GI problems at all; 100=severe bowel or GI problems).
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.