Actively Recruiting
Phase II Placebo-Controlled Study of BacoMind4 Bacopa Monnieri Extract in Gulf War Illness
Led by Nova Southeastern University · Updated on 2025-07-04
170
Participants Needed
1
Research Sites
N/A
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 affects multiple major organ systems and causes symptoms such as severe fatigue, memory and thinking difficulties, headaches, sleep problems, digestive issues, skin rashes, and joint pain. This phase II, double-masked, randomized, placebo-controlled study investigates whether the dietary supplement Bacopa can help manage central nervous system symptoms of Gulf War Illness. The study focuses on evaluating cognitive function and safety of Bacopa in affected Gulf War Veterans born between 1942 and 1978 who meet specific case definitions for the illness. Participants will be randomly assigned to one of two groups: one receives 300 mg daily of BacoMind4 Bacopa monnieri standardized extract for 12 weeks, and the other receives a placebo that looks identical. The treatment period lasts 12 weeks, with follow-up assessments continuing for an additional 4 weeks after treatment ends. The study is conducted remotely using online tools and telephone interviews, and laboratory tests are done locally for a subgroup of participants to measure biomarkers related to brain health and inflammation. During the study, participants will be assessed at baseline, 6, 12, and 16 weeks for cognitive performance using the California Verbal Learning Test (CVLT-II), physical health, vitality, sleep, pain, and symptom severity. Blood samples will be collected at baseline and at 12 weeks for some participants. Safety will be monitored through biweekly phone calls. The total observation period covers 16 weeks to evaluate both immediate and lasting effects of the treatment.
CONDITIONS
Brief 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 between August 1990 and July 1991
- Meet modified Kansas and CDC case definitions for Gulf War Illness
- Stable treated illnesses of aging allowed if controlled at screening
- Stable PTSD, major depressive disorder, and mild traumatic brain injury allowed if not hospitalized in past 5 years
- Able to consent to participate
- If of childbearing potential, must use effective contraception during study
- Agree to participate in follow-up visits
You will not qualify if you...
- Scheduled for surgery during study or recent surgery within 3 to 6 months
- Current untreated major depression with psychotic features, schizophrenia, bipolar disorder, delusional disorders, dementias, or recent substance abuse
- Serious allergic diseases including allergies to study product or placebo ingredients
- Renal disease or dialysis
- Hepatic insufficiency beyond specified limits
- Pregnancy
- Heavy alcohol or tobacco use exceeding defined limits
- Exclusionary diagnoses explaining fatigue such as organ failure, chronic infections, major neurological diseases, cancer or cancer treatment, untreated sleep disorders, uncontrolled diabetes
- Temporary conditions at screening requiring resolution before rescreening
- Participation in another interventional clinical trial within 6 weeks
- Use of Bacopa within 6 weeks prior to enrollment
- Diagnosed bleeding disorders or current use of anticoagulants except low dose NSAIDs
- Severe traumatic brain injury excluded as per criteria in study definitions
- Untreated or inadequately controlled thyroid disorders in last 3 months or abnormal free T4 levels
- Active infections at screening requiring resolution before rescreening
- Use of biologic immune modifiers affecting immune function
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (remote)
Duration - 12 weeks
Participants receive either BacoMind® Bacopa monnieri standardized extract or placebo daily for 12 weeks. Cognitive function and other health measures are assessed remotely during this period.
Biweekly phone calls for safety monitoring and assessments at baseline, 6 weeks, and 12 weeks (remote)
Duration - 4 weeks
Participants are observed for 4 weeks after treatment to assess immediate effects and durability of response, with additional remote assessments.
Assessment at 16 weeks (remote)
Trial Site Locations
Total: 1 location
1
Nova Southeastern University
Davie, Florida, United States, 33314
Actively Recruiting
Research Team
M
Mayra Vidro, MPH
K
Karen Kesler, PhD
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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