Study of Bacopa in Gulf War Illness Patients

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 WarIllness (GWI). The modified Kansas definition, which includes the CDC criteriaincludes:

4. Allowance for normal illnesses of aging, such as hypertension and diabetes ifthe conditions are treated and are in demonstrable stable and normal ranges atthe time of screening and assessment.

5. Allowance of stable comorbid conditions such as post-traumatic stress disorder (PTSD), major depressive disorder (MDD), and traumatic brain injury (TBI) thathave not required hospitalization in the 5 years prior to recruitment. SevereTBI is excluded.

6. Able to consent to the study

7. Participants of childbearing potential must practice effective contraception duringthe study so that, in the opinion of the Investigator, they will be compliant withbirth control measures during the study.

8. Agrees to participate in follow-up visits.

Exclusion Criteria:

1. They are scheduled for a surgery during the period of study participation, had minorsurgery within 3 months prior to screening, or had major surgery within 6 monthsprior to screening,

2. Self-report of current untreated major depression with psychotic or melancholicfeatures (as determined by self-report), schizophrenia, bipolar disorder, delusionaldisorders, dementias of any type, or substance abuse during the last two years (excluding cannabis products),

3. Any serious allergic disease (self-report), possibly resulting in anaphylaxis, suchas food/drug allergies, including allergic asthma, or allergy to any ingredient ofthe active product or placebo, including allergies to FD&C Yellow No. 5 (tartrazine),

4. Renal disease (self-report; laboratory results: renal insufficiency with serumcreatinine > 2.0 mg/dL or eGFR < 44; or currently on renal dialysis),

5. Hepatic insufficiency (bilirubin >2.5mg/dL or transaminases >3x the upper limit ofnormal (ULN)). Participants with Gilberts syndrome are eligible for the study ifother liver function tests are normal, regardless of bilirubin level,

6. Pregnancy (premenopausal female participants),

7. Current heavy alcohol or tobacco use (self-report). Heavy use is defined as alcoholconsumption 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 20cigarettes (or equivalent) per day.

8. Current exclusionary diagnosis that could reasonably explain the symptoms of theirfatiguing illness and their severity, using the exclusion criteria best described inthe Ambiguities in case definition paper for Chronic Fatigue Syndrome (CFS), asdescribed in detail in Reeves et al., 2003, which clarifies exclusionary conditions.Specifically, the exclusionary diagnoses that are not otherwise listed abovecomprise:

• organ failure (e.g., emphysema, cirrhosis, cardiac failure, chronic renalfailure)

• 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 suchas (e.g., epilepsy, stroke, brain tumor, multiple sclerosis, Parkinson'sDisease, 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 currentuse 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)

9. Temporary conditions discovered at screening for which participants may berescreened 6 weeks after resolution of condition.

• Temporary effects of medications

• Temporary sleep deprivation

• Untreated hypothyroidism/hyperthyroidism, hypothyroidism/hyperthyroidism thathas been inadequately controlled during the last 3 months, or free T4 level notwithin normal limit

• Active infection

10. Participating in another interventional clinical trial of an investigational therapy (including social-behavioral therapy) within 6 weeks prior to consent to participatein this study, or planning to participate in another interventional clinical trialof an investigational therapy during this study,

11. Use of Bacopa within 6 weeks prior to the enrollment in this study,

12. Diagnosed bleeding disorder or current use of anticoagulants and/or antiplatelets,except for low dose nonsteroidal anti-inflammatories (NSAIDS).