Actively Recruiting
Study of Bacopa in Gulf War Illness Patients
Led by Nova Southeastern University · Updated on 2025-07-04
170
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
Sponsors
N
Nova Southeastern University
Lead Sponsor
R
RTI International
Collaborating Sponsor
AI-Summary
What this Trial Is About
Gulf War Illness is a condition that affects multiple major organ systems, resulting in a diverse array of symptoms that include debilitating fatigue, memory and cognition difficulties, headaches, sleep disturbances, gastrointestinal problems, skin rashes, and musculoskeletal/joint pain. This phase II, double masked, randomized, placebo-controlled, two-arm study will evaluate cognitive function as evidence of efficacy of the nutraceutical intervention, Bacopa, on central nervous system symptom management of Gulf War Illness, along with assessments of safety of the intervention.
CONDITIONS
Official Title
Study of Bacopa in Gulf War Illness Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Born between 1942 and 1978
- Served in the Gulf War theater anytime from August 1990 to July 1991
- Meet the modified Kansas and CDC case definitions for Gulf War Illness
- Stable and treated common aging illnesses like hypertension or diabetes
- Stable PTSD, major depressive disorder, or traumatic brain injury without hospitalization in past 5 years
- Able to consent to participate
- If able to bear children, agree to effective birth control during the study
- Agree to participate in follow-up visits
You will not qualify if you...
- Scheduled for surgery during the study or had minor surgery within 3 months or major surgery within 6 months before screening
- Current untreated major depression with psychotic or melancholic features, schizophrenia, bipolar disorder, delusional disorders, dementias, or substance abuse in last 2 years (excluding cannabis)
- Serious allergic diseases or allergies to study product ingredients including FD&C Yellow No. 5
- Renal disease with creatinine over 2.0 mg/dL, eGFR under 44, or dialysis
- Liver insufficiency with bilirubin over 2.5 mg/dL or high liver enzymes except Gilbert's syndrome with normal other tests
- Pregnancy
- Heavy alcohol or tobacco use exceeding defined limits
- Diagnoses that could explain fatiguing illness symptoms such as organ failure, chronic infections, major neurological diseases, cancer or treatments, untreated primary sleep disorders, uncontrolled diabetes
- Temporary conditions like medication effects, sleep deprivation, untreated thyroid disorders, or active infection at screening
- Participation in another investigational therapy trial within 6 weeks before or planned during this study
- Use of Bacopa within 6 weeks before enrollment
- Diagnosed bleeding disorders or current use of anticoagulants/antiplatelets except low dose NSAIDs
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Nova Southeastern University
Davie, Florida, United States, 33314
Actively Recruiting
Research Team
M
Mayra Vidro, MPH
CONTACT
K
Karen Kesler, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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