Study of Bacopa in Gulf War Illness Patients

Exclusion Criteria21

• 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),
• Hepatic insufficiency (bilirubin \>2.5mg/dL or transaminases \>3x the upper limit of normal (ULN)). Participants with Gilberts syndrome are eligible for the study if other liver function tests are normal, regardless of bilirubin level,
• Pregnancy (premenopausal female participants),
• Current heavy alcohol or tobacco use (self-report). Heavy use is defined as alcohol consumption not to exceed approximately 15 drinks per week (with a drink defined as 12 oz beer, 5 oz wine, or 1.5 oz distilled spirits) and tobacco use not to exceed 20 cigarettes (or equivalent) per day.
• organ failure (e.g., emphysema, cirrhosis, cardiac failure, chronic renal failure)
• chronic infections (e.g., AIDS, hepatitis B or C) or inflammatory bowel disease (IBD) (via self report)
• major neurologic diseases that could cause fatigue or neurologic deficits such as (e.g., epilepsy, stroke, brain tumor, multiple sclerosis, Parkinson's Disease, Alzheimer's disease) or history of CNS demyelinating disease (e.g., multiple sclerosis, neuromyelitis optica spectrum disorder) (Self report),
• cancer or cancer treatment (e.g., chemotherapy, radiation of brain), or current use of biologic modifiers that could affect immune function (e.g., Etanercept, Rituximab) (self-report)
• untreated primary sleep disorders (e.g., sleep apnea, narcolepsy)
• uncontrolled diabetes (HgbA1c \> 7)
• Temporary conditions discovered at screening for which participants may be rescreened 6 weeks after resolution of condition.
• Temporary effects of medications
• Temporary sleep deprivation
• Untreated hypothyroidism/hyperthyroidism, hypothyroidism/hyperthyroidism that has been inadequately controlled during the last 3 months, or free T4 level not within normal limit
• Active infection
• Participating in another interventional clinical trial of an investigational therapy (including social-behavioral therapy) within 6 weeks prior to consent to participate in this study, or planning to participate in another interventional clinical trial of an investigational therapy during this study,
• Use of Bacopa within 6 weeks prior to the enrollment in this study,
• Diagnosed bleeding disorder or current use of anticoagulants and/or antiplatelets, except for low dose nonsteroidal anti-inflammatories (NSAIDS).