Phase II, Placebo-controlled Study of BacoMind® Bacopa Monnieri Standardized Extract in Gulf War Illness
Nova Southeastern University
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.
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 as…
Eligibility
- Age range
- 46–78 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Born in years 1942 to1978 2. Served in the Gulf War theater for any period between August 1990 and July 1991 3. Meets modified Kansas case definition criteria and CDC case definition for Gulf War Illness (GWI). The modified Kansas definition, which includes the CDC criteria includes: 1. Allowance for normal illnesses of aging, such as hypertension and diabetes if the conditions are treated and are in demonstrable stable and normal ranges at the time of screening and assessment. 2. Allowance of stable comorbid conditions such as post-traumatic stress disorder (PTS…
Interventions
- Dietary SupplementBacoMind® (Bacopa monnieri standardized extract)
BacoMind® (Bacopa monnieri standardized extract) 300 mg daily capsule.
- DrugPlacebo
Daily placebo capsule identical in size, color, and shape to that of the Bacopa capsules.
Location
- Nova Southeastern UniversityDavie, Florida