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Study of Bacopa for Gulf War Illness

This study is testing BacoMind® (Bacopa monnieri standardized extract), a dietary supplement, to see if it can help manage central nervous system symptoms like memory and thinking difficulties in people with Gulf War Illness (GWI). GWI is a condition with symptoms like fatigue, headaches, and memory problems. You might be eligible if you are 46 to 78 years old, served in the Gulf War between August 1990 and July 1991, and meet specific criteria for GWI. The study will measure success by looking at changes in your cognitive function (thinking and memory skills) using a test called the California Verbal Learning Test (CVLT-II) after 12 weeks. The current status of this study is unclear, and it plans to enroll 170 participants.

Study design
This is a Phase II, double-masked (neither you nor your doctor will know if you're getting the active treatment or placebo), randomized, placebo-controlled study with two groups, involving 170 participants.
What's involved
You would take a daily capsule for 12 weeks. You will have online assessments and telephone interviews, and laboratory tests at the beginning and after 12 weeks. Monitoring phone calls will be made every two weeks.
Compensation
Not stated in the trial record.
Follow-up
Your cognitive function will be assessed at 12 weeks after starting the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04927338

Study of Bacopa in Gulf War Illness Patients

Recruiting
PHASE2Ages 46–78InterventionalTreatment
Nova Southeastern University
~170 participants
Updated 2025-07-04 on ClinicalTrials.gov
What's tested:BacoMind® (Bacopa monnieri standardized extract)Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
California Verbal Learning Test (CVLT-II) Assessment
Measured over 12 weeks

Conditions

Gulf War Illness

Explore related trials

Gulf war syndrome

NCT04927338

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Nova Southeastern University

    Davie, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Amanpreet Cheema, PhD · PRINCIPAL_INVESTIGATOR · Nova Southeastern Univeristy

Who to contact

Mayra Vidro, MPH
[email protected]
954-262-2841
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Exclusion

organ failure (e.g., emphysema, cirrhosis, cardiac failure, chronic renal failure)
chronic infections (e.g., AIDS, hepatitis B or C) or inflammatory bowel disease (IBD) (via self report)
major neurologic diseases that could cause fatigue or neurologic deficits such as (e.g., epilepsy, stroke, brain tumor, multiple sclerosis, Parkinson's Disease, Alzheimer's disease) or history of CNS demyelinating disease (e.g., multiple sclerosis, neuromyelitis optica spectrum disorder) (Self report),
cancer or cancer treatment (e.g., chemotherapy, radiation of brain), or current use of biologic modifiers that could affect immune function (e.g., Etanercept, Rituximab) (self-report)
untreated primary sleep disorders (e.g., sleep apnea, narcolepsy)
uncontrolled diabetes (HgbA1c \> 7) 9. Temporary conditions discovered at screening for which participants may be rescreened 6 weeks after resolution of condition.
Temporary effects of medications
Temporary sleep deprivation
Untreated hypothyroidism/hyperthyroidism, hypothyroidism/hyperthyroidism that has been inadequately controlled during the last 3 months, or free T4 level not within normal limit
Active infection 10. Participating in another interventional clinical trial of an investigational therapy (including social-behavioral therapy) within 6 weeks prior to consent to participate in this study, or planning to participate in another interventional clinical trial of an investigational therapy during this study, 11. Use of Bacopa within 6 weeks prior to the enrollment in this study, 12. Diagnosed bleeding disorder or current use of anticoagulants and/or antiplatelets, except for low dose nonsteroidal anti-inflammatories (NSAIDS).

What this trial measures

  • California Verbal Learning Test (CVLT-II) Assessment12 weeks

    Change in mean CVLT-II long delay free recall from baseline to 12 weeks. Higher CVLT-II scores are considered clinically better, and the raw CVLT-II scores will be used in analyses and reporting.