Effects of Botanical Microglia Modulators in Gulf War Illness
2 other identifiers
interventional
36
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 13, 2016
CompletedFirst Posted
Study publicly available on registry
September 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedResults Posted
Study results publicly available
January 24, 2025
CompletedJanuary 24, 2025
December 1, 2024
3.2 years
September 13, 2016
April 4, 2024
December 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Overall Gulf War Illness Disease Severity
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).
Week 17
Secondary Outcomes (7)
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 Mood Symptom Severity
Week 17
Change From Baseline in Dermatological Symptom Severity
Week 17
- +2 more secondary outcomes
Study Arms (10)
Boswellia Serrata
EXPERIMENTAL400-800mg in capsule form by mouth every day
Curcumin
EXPERIMENTAL1000-2000mg in capsule form by mouth every day
Epimedium
EXPERIMENTAL1000-2000mg in capsule form by mouth every day
Fisetin
EXPERIMENTAL200-800mg in capsule form by mouth every day
Luteolin
EXPERIMENTAL200-400mg in capsule form by mouth every day
Nettle
EXPERIMENTAL435-1305mg in capsule form by mouth every day
Pycnogenol
EXPERIMENTAL200-400mg in capsule form by mouth every day
Reishi Mushroom
EXPERIMENTAL1600-3200mg in capsule form by mouth every day
Resveratrol
EXPERIMENTAL200-600mg in capsule form by mouth every day
Placebo
PLACEBO COMPARATORin capsule form by mouth every day
Interventions
Eligibility Criteria
You may qualify if:
- Male
- Age 39-65, inclusive
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Related Publications (3)
Younger J, Donovan EK, Hodgin KS, Ness TJ. A Placebo-Controlled, Pseudo-Randomized, Crossover Trial of Botanical Agents for Gulf War Illness: Reishi Mushroom (Ganoderma lucidum), Stinging Nettle (Urtica dioica), and Epimedium (Epimedium sagittatum). Int J Environ Res Public Health. 2021 Apr 1;18(7):3671. doi: 10.3390/ijerph18073671.
PMID: 33915962DERIVEDHodgin KS, Donovan EK, Kekes-Szabo S, Lin JC, Feick J, Massey RL, Ness TJ, Younger JW. A Placebo-Controlled, Pseudo-Randomized, Crossover Trial of Botanical Agents for Gulf War Illness: Resveratrol (Polygonum cuspidatum), Luteolin, and Fisetin (Rhus succedanea). Int J Environ Res Public Health. 2021 Mar 3;18(5):2483. doi: 10.3390/ijerph18052483.
PMID: 33802381DERIVEDDonovan EK, Kekes-Szabo S, Lin JC, Massey RL, Cobb JD, Hodgin KS, Ness TJ, Hangee-Bauer C, Younger JW. A Placebo-Controlled, Pseudo-Randomized, Crossover Trial of Botanical Agents for Gulf War Illness: Curcumin (Curcuma longa), Boswellia (Boswellia serrata), and French Maritime Pine Bark (Pinus pinaster). Int J Environ Res Public Health. 2021 Mar 3;18(5):2468. doi: 10.3390/ijerph18052468.
PMID: 33802272DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jarred Younger
- Organization
- University of Alabama at Birmingham
Study Officials
- PRINCIPAL INVESTIGATOR
Jarred W Younger, PhD
University of Alabama at Birmingham
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 13, 2016
First Posted
September 21, 2016
Study Start
July 1, 2016
Primary Completion
September 1, 2019
Study Completion
September 1, 2022
Last Updated
January 24, 2025
Results First Posted
January 24, 2025
Record last verified: 2024-12