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Completed

NCT Number: NCT02909686

Effects of Botanical Microglia Modulators in Gulf War Illness

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.

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Key information

Conditions

Gulf War Illness Occupational Diseases Persian Gulf Syndrome War-Related Injuries Wounds and Injuries

Age range

39 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male
  • 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

Exclusion criteria

  • 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

Treatment and study plan

Boswellia Serrata

Dietary Supplement

Other names: Indian frankincense

Curcumin

Dietary Supplement

Other names: Curcumasorb, Turmeric extract, Meriva

Epimedium

Dietary Supplement

Other names: Barrenwort, Bishop's Hat, Fairy Wings, Horny Goat Weed, Yin Yang Huo

Fisetin

Dietary Supplement

Luteolin

Dietary Supplement

Nettle

Dietary Supplement

Other names: Common Nettle, urtica dioica, Stinging Nettle

Pycnogenol

Dietary Supplement

Other names: Maritime Pine Extract, Pine Bark Extract

Reishi Mushroom

Dietary Supplement

Resveratrol

Dietary Supplement

Other names: Red Wine Extract

Placebo

Dietary Supplement

Primary outcomes

  1. Change From Baseline in Overall Gulf War Illness Disease Severity

    Time frame: 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).

Secondary outcomes

  1. Change From Baseline in Pain Severity

    Time frame: Week 17

    Self reported pain symptom severity evening reports were collected for the duration of the study. Scale= change from baseline in overall GWI pain severity (-100 to +100, with positive numbers indicating how much the symptom improved).

  2. Change From Baseline in Fatigue Severity

    Time frame: Week 17

    Self reported fatigue symptom severity evening reports were collected for the duration of the study. Scale= change from baseline in overall GWI fatigue severity (-100 to +100, with positive numbers indicating how much the symptom improved).

  3. Change From Baseline in Cognitive Symptom Severity

    Time frame: Week 17

    Self reported Cognitive Symptom Severity evening reports were collected for the duration of the study. Scale= change from baseline in overall Cognitive Symptom Severity (-100 to +100, with positive numbers indicating how much the symptom improved).

  4. Change From Baseline in Mood Symptom Severity

    Time frame: Week 17

    Self reported Mood Symptom Severity evening reports were collected for the duration of the study. Scale= change from baseline in overall Mood Symptom Severity (-100 to +100, with positive numbers indicating how much the symptom improved).

  5. Change From Baseline in Dermatological Symptom Severity

    Time frame: Week 17

    Self reported Dermatological Symptom Severity evening reports were collected for the duration of the study. Scale= change from baseline in overall Dermatological Symptom Severity (-100 to +100, with positive numbers indicating how much the symptom improved).

  6. Change From Baseline in Respiratory Symptom Severity

    Time frame: Week 17

    Self reported Respiratory Symptom Severity evening reports were collected for the duration of the study. Scale= change from baseline in overall Respiratory Symptom Severity (-100 to +100, with positive numbers indicating how much the symptom improved).

  7. Change From Baseline in Gastrointestinal Symptom Severity

    Time frame: Week 17

    Self reported Gastrointestinal Symptom Severity evening reports were collected for the duration of the study. Scale= change from baseline in overall Gastrointestinal Symptom Severity (-100 to +100, with positive numbers indicating how much the symptom improved).

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Congressionally Directed Medical Research Programs

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2022
First posted
Sep 21, 2016
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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