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Study of Bacopa in Gulf War Illness Patients

StatusRecruiting
PhasePhase 2
Started
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Record status
This record was last updated July 4, 2025 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary and study completion dates: Sep 2025 to Apr 2026
    • Site contact updated
    v9
  2. Primary and study completion dates: Sep 2024 to Sep 2025v8
  3. Enrollment target: 264 to 170
    • Eligibility criteria revised
    • Study description revised
    v7
  4. Re-verified, no change to tracked fieldsv6
  5. Eligibility criteria shortened, about 10 wordsv5
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  1. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Start date changed from estimate of Sep 2022 to Dec 1, 2022
    • Site details revised
    • Eligibility criteria expanded, about 4 words
    • Study description expanded, about 1 word
  2. Primary completion date: May 2023 to Sep 2024v3 Show 7 more changesShow less
    • Start date: Sep 2021 to Sep 2022
    • Study sites: 0 to 1
    • Study completion date: Jul 2023 to Sep 2024
    • Interventions: BACOPA (Drug), Placebo (Drug) to BacoMind® (Bacopa monnieri standardized extract) (Dietary Supplement), Placebo (Drug)
    • Eligibility criteria expanded, about 134 words
    • Secondary endpoints: 3 to 4
    • Study description shortened, about 26 words
  3. Study description shortened, about 10 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04927338
Lead Sponsor Nova Southeastern University
Collaborators: RTI International, Boston University
Conditions
(from sponsor)		 Gulf War Illness
Enrollment 170 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov