Study of Bacopa in Gulf War Illness Patients

Part of paid clinical trials in Davie, Florida.

Sponsor
Nova Southeastern University
Study ID
NCT04927338
Phase
PHASE2
Status
Recruiting
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Conditions

  • Gulf War Illness

Eligibility Criteria

Sex
ALL
Age
46 Years - 78 Years
Healthy Volunteers
Not accepted

Interventions

  • BacoMind® (Bacopa monnieri standardized extract) — DIETARY_SUPPLEMENT
    BacoMind® (Bacopa monnieri standardized extract) 300 mg daily capsule.
  • Placebo — DRUG
    Daily placebo capsule identical in size, color, and shape to that of the Bacopa capsules.

Study Details

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.

Key Dates

Start date
Dec 1, 2022
Status verified
Jul 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BacoMind® 300mg/day
    Participants randomized to the experimental arm will receive 12 weeks of 300 mg/day BacoMind® Bacopa monnieri standardized extract.
  • Placebo Comparator: Placebo
    Participants randomized to the placebo arm will receive 12 weeks of daily placebo identical to the experimental treatment in size, color, and shape.

Primary Outcome Measure

California Verbal Learning Test (CVLT-II) Assessment [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nova Southeastern UniversityDavieFlorida33314
Mayra Vidro, MPH
[email protected]
(954) 262-2841
Amanpreet Cheema, PhD
[email protected]
(954) 262-2871
Amanpreet Cheema, PhD (PRINCIPAL_INVESTIGATOR)
Nancy Klimas, MD (SUB_INVESTIGATOR)
Kristina Aenlle, PhD (SUB_INVESTIGATOR)

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