At a glance
ClinicalIndex Comparison Record- ✓Born between 1942 and 1978
- ✓Served in Gulf War theater between August 1990 and July 1991
- ✓Meets modified Kansas case definition and CDC case definition for Gulf War Illness
- ✓Allowance for treated, stable normal-range hypertension and diabetes
- ✕Scheduled for surgery, or had minor surgery within 3 months or major surgery within 6 months
- ✕Untreated major depression with psychotic or melancholic features, schizophrenia, bipolar disorder, delusional disorders, dementias, or substance abuse in last 2 years
- ✕Serious allergic disease with anaphylaxis risk or allergy to study ingredients
- ✕Organ failure including emphysema, cirrhosis, cardiac failure, chronic renal failure
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT04927338Phase 2RecruitingMonitorUpdated 11mo ago · Completion was 3mo agoPhase II, Placebo-controlled Study of BacoMind® Bacopa Monnieri Standardized Extract in Gulf War Illness
In Brief
A Phase 2 clinical trial evaluating BacoMind® (Bacopa monnieri standardized extract) and Placebo for Gulf War Illness. Currently recruiting, targeting 170 participants across 1 site.
Signals
Detailed 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.
Study Details
Timeline
Interventions
BacoMind® (Bacopa monnieri standardized extract) 300 mg daily capsule.
Daily placebo capsule identical in size, color, and shape to that of the Bacopa capsules.