NCT04927338

Study of Bacopa in Gulf War Illness Patients

Phase II, Placebo-controlled Study of BacoMind® Bacopa Monnieri Standardized Extract in Gulf War Illness

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Nova Southeastern University · Academic / Other
• Sex: All
• Age: 46 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a study in Gulf War Veterans born between 1946 and 1978 who meet the modified Kansas and Centers for Disease Control and Prevention (CDC) case definitions for Gulf War Illness. This phase II, double-masked, randomized, placebo-controlled, two-arm study will focus on assessing cognitive function as evidence of efficacy of the nutraceutical intervention, Bacopa, on central nervous system symptom management of Gulf War Illness. 170 participants will be randomized 1:1 to receive either 12 weeks of the intervention (Bacopa) or placebo. Participants will be evaluated "remotely" via online assessment tools and telephone interviews, allowing participation from a nationwide catchment area. Primary assessment via the California Verbal Learning Test, Second Edition (CVLT-II) will occur at baseline and 12 weeks, along with laboratory assessments for all participants at baseline, and a self-selected subgroup at 12 weeks. Randomization to the intervention or placebo arms will be stratified by membership in the 12-week follow-up laboratory subgroup and sex. Laboratory draws will be performed at the participant's local clinical laboratory and will allow for measurements of putative biomarkers of neuron health and structural integrity along with biomarkers of inflammation and immune signaling. Monitoring phone calls will be made to the participant biweekly to assess safety. Participants will also undergo subjective assessments of physical health, vitality, sleep, pain, and symptom severity at baseline, 6, 12, and 16 weeks. Thus, participants will be observed through the treatment period (12 weeks) and for 4 weeks after completion to assess immediate effects and durability of the response.

Conditions

• Gulf War Illness

Interventions

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

Timeline

• Start date: 2022-12-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2021-06-16
• Last updated: 2025-07-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study