Study of Bacopa in Gulf War Illness Patients
ConditionGulf War Illness
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age46-78
SponsorNova Southeastern University
About this trial
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.
Eligibility criteria
Qualifiers
Born in years 1942 to1978
Served in the Gulf War theater for any period between August 1990 and July 1991
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.
Allowance of stable comorbid conditions such as post-traumatic stress disorder (PTSD), major depressive disorder (MDD), and traumatic brain injury (TBI) that have not required hospitalization in the 5 years prior to recruitment. Severe TBI is excluded.
Disqualifiers
They are scheduled for a surgery during the period of study participation, had minor surgery within 3 months prior to screening, or had major surgery within 6 months prior to screening,
Self-report of current untreated major depression with psychotic or melancholic features (as determined by self-report), schizophrenia, bipolar disorder, delusional disorders, dementias of any type, or substance abuse during the last two years (excluding cannabis products),
Any serious allergic disease (self-report), possibly resulting in anaphylaxis, such as food/drug allergies, including allergic asthma, or allergy to any ingredient of the active product or placebo, including allergies to FD&C Yellow No. 5 (tartrazine),
Renal disease (self-report; laboratory results: renal insufficiency with serum creatinine > 2.0 mg/dL or eGFR < 44; or currently on renal dialysis),
Trial design
Treatments tested in this trial
- BacoMind® (Bacopa monnieri standardized extract)
- Placebo
Treatment groups
170 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov