[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100433685":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":49,"responsibleParty":75,"collaborators":78,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":33,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":33,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":51,"whyStopped":33,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Nova Southeastern University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BacoMind® 300mg\u002Fday","EXPERIMENTAL","Participants randomized to the experimental arm will receive 12 weeks of 300 mg\u002Fday BacoMind® Bacopa monnieri standardized extract.",[13],"Dietary Supplement: BacoMind® (Bacopa monnieri standardized extract)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants randomized to the placebo arm will receive 12 weeks of daily placebo identical to the experimental treatment in size, color, and shape.",[19],"Drug: Placebo",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","BacoMind® (Bacopa monnieri standardized extract)","BacoMind® (Bacopa monnieri standardized extract) 300 mg daily capsule.",[9],[27,28],"Bacopa","Bacopa monnieri",{"type":30,"name":15,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Daily placebo capsule identical in size, color, and shape to that of the Bacopa capsules.",[15],null,[35],{"name":36,"affiliation":37,"role":38},"Amanpreet Cheema, PhD","Nova Southeastern Univeristy","PRINCIPAL_INVESTIGATOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":33,"email":44},"Mayra Vidro, MPH","CONTACT","954-262-2841","mvidro@nova.edu",{"name":46,"role":42,"phone":47,"phoneExt":33,"email":48},"Karen Kesler, PhD","919-485-1429","kkesler@rti.org",[50],{"facility":5,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Davie","Florida","33314","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-80.2331,26.06287,{"lat":61,"lon":60},[64,66,69,70,73],{"name":41,"role":42,"phone":65,"phoneExt":33,"email":44},"(954) 262-2841",{"name":36,"role":42,"phone":67,"phoneExt":33,"email":68},"(954) 262-2871","acheema@nova.edu",{"name":36,"role":38,"phone":33,"phoneExt":33,"email":33},{"name":71,"role":72,"phone":33,"phoneExt":33,"email":33},"Nancy Klimas, MD","SUB_INVESTIGATOR",{"name":74,"role":72,"phone":33,"phoneExt":33,"email":33},"Kristina Aenlle, PhD",{"type":38,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Amanpreet Cheema","Assistant Professor",[79,81],{"name":80,"class":6},"RTI International",{"name":82,"class":6},"Boston University","100433685","phase-2-study-of-bacopa-in-gulf-war-illness-patients-100433685",false,"NCT04927338","Study of Bacopa in Gulf War Illness Patients","Phase II, Placebo-controlled Study of BacoMind® Bacopa Monnieri Standardized Extract in Gulf War Illness","Inclusion Criteria:\n\n1. Born in years 1942 to1978\n2. Served in the Gulf War theater for any period between August 1990 and July 1991\n3. 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:\n\n   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.\n   2. 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.\n4. Able to consent to the study\n5. Participants of childbearing potential must practice effective contraception during the study so that, in the opinion of the Investigator, they will be compliant with birth control measures during the study.\n6. Agrees to participate in follow-up visits.\n\nExclusion Criteria:\n\n1. 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,\n2. 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),\n3. Any serious allergic disease (self-report), possibly resulting in anaphylaxis, such as food\u002Fdrug allergies, including allergic asthma, or allergy to any ingredient of the active product or placebo, including allergies to FD\\&C Yellow No. 5 (tartrazine),\n4. Renal disease (self-report; laboratory results: renal insufficiency with serum creatinine \\> 2.0 mg\u002FdL or eGFR \\\u003C 44; or currently on renal dialysis),\n5. Hepatic insufficiency (bilirubin \\>2.5mg\u002FdL 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,\n6. Pregnancy (premenopausal female participants),\n7. 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.\n8. Current exclusionary diagnosis that could reasonably explain the symptoms of their fatiguing illness and their severity, using the exclusion criteria best described in the Ambiguities in case definition paper for Chronic Fatigue Syndrome (CFS), as described in detail in Reeves et al., 2003, which clarifies exclusionary conditions. Specifically, the exclusionary diagnoses that are not otherwise listed above comprise:\n\n   * organ failure (e.g., emphysema, cirrhosis, cardiac failure, chronic renal failure)\n   * chronic infections (e.g., AIDS, hepatitis B or C) or inflammatory bowel disease (IBD) (via self report)\n   * 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),\n   * 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)\n   * untreated primary sleep disorders (e.g., sleep apnea, narcolepsy)\n   * uncontrolled diabetes (HgbA1c \\> 7)\n9. Temporary conditions discovered at screening for which participants may be rescreened 6 weeks after resolution of condition.\n\n   * Temporary effects of medications\n   * Temporary sleep deprivation\n   * Untreated hypothyroidism\u002Fhyperthyroidism, hypothyroidism\u002Fhyperthyroidism that has been inadequately controlled during the last 3 months, or free T4 level not within normal limit\n   * Active infection\n10. 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,\n11. Use of Bacopa within 6 weeks prior to the enrollment in this study,\n12. Diagnosed bleeding disorder or current use of anticoagulants and\u002For antiplatelets, except for low dose nonsteroidal anti-inflammatories (NSAIDS).","ALL","46 Years","78 Years",{"count":94,"type":95},170,"ESTIMATED","INTERVENTIONAL",[98],"PHASE2","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\u002Fjoint 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.",[101],"Gulf War Illness",[103,101,104],"Veterans","Nutraceutical","2025-07-02",{"date":107,"type":108},"2025-07-04","ACTUAL",{"date":110,"type":108},"2022-12-01",{"date":112,"type":95},"2026-04",{"name":5,"class":6},1]