N/A N=96 Randomized Quadruple-blind Other

Effects of Botanical Microglia Modulators in Gulf War Illness

Gulf War Illness

Bottom Line

View on ClinicalTrials.gov: NCT02909686 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: Change From Baseline in Overall Gulf War Illness Disease Severity — 13; 0; 8; -1 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Boswellia Serrata (Dietary_supplement); Curcumin (Dietary_supplement); Epimedium (Dietary_supplement); Fisetin (Dietary_supplement); Luteolin (Dietary_supplement); Nettle (Dietary_supplement); Pycnogenol (Dietary_supplement); Reishi Mushroom (Dietary_supplement); Resveratrol (Dietary_supplement); Placebo (Dietary_supplement)
Age: Adult, Older Adult · 39+ yrs
Sex: Male
Sponsor: University of Alabama at Birmingham
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Overall Gulf War Illness Disease Severity	13; 0; 8; -1; 12; 19	—
SECONDARY Change From Baseline in Pain Severity	13; -1; 8; 1; 11; 14	—
SECONDARY Change From Baseline in Fatigue Severity	6; 4; 4; -5; 11; 4	—
SECONDARY Change From Baseline in Cognitive Symptom Severity	-6; 7; 0; 3; -4; -11	—
SECONDARY Change From Baseline in Mood Symptom Severity	7; 12; 6; 0; 1; -9	—
SECONDARY Change From Baseline in Dermatological Symptom Severity	3; -4; -3; 0; 1; 1	—
SECONDARY Change From Baseline in Respiratory Symptom Severity	-3; -1; -5; 0; 3; -2	—
SECONDARY Change From Baseline in Gastrointestinal Symptom Severity	9; -5; -2; 8; 6; 1	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02909686). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.