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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
BacoMind® (Bacopa monnieri standardized extract)
Dietary supplementBacoMind® (Bacopa monnieri standardized extract) 300 mg daily capsule.
Placebo
DrugDaily placebo capsule identical in size, color, and shape to that of the Bacopa capsules.
Treatment groups
170 Participants
are divided into 2 treatment groupsGroup A: BacoMind® 300mg/dayExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
California Verbal Learning Test (CVLT-II) Assessment
Change in mean CVLT-II long delay free recall from baseline to 12 weeks. Higher CVLT-II scores are considered clinically better, and the raw CVLT-II scores will be used in analyses and reporting.
Time frame
12 weeksSecondary outcomes
1
Blood Biomarker Concentrations
Putative biomarkers 18-plex cytokines, glutamate, brain-derived neurotrophic factor (BDNF), and neurofilament light chain (NfL) will be measured from blood drawn at baseline from all participants and then at 12 weeks from a subgroup of participants. Differences in the mean concentrations of each of the biomarkers will be assessed at the end of the intervention period in the 12 week blood draw subgroup.
Time frame
12 weeks2
Veterans RAND 36 Item Health Survey (VR-36©)
Change in mean VR-36 physical component score from baseline to 12 weeks. Normed values of the VR-36 physical component score (PCS) will be used based on US population estimates. The minimum score is 0 and the maximum score is 100. A higher score indicates better health outcomes.
Time frame
12 weeks3
Veterans RAND 36 Item Health Survey (VR-36©)
Change in mean VR-36 physical component score (PCS) from 12 weeks to 16 weeks. Normed values of the VR-36 PCS will be used based on US population estimates. The minimum score is 0 and the maximum score is 100. A higher score indicates better health outcomes.
Time frame
16 weeks4
Review of Treatment Related Adverse Events
Number of participants with treatment-related adverse events as assessed by frequency of safety events during the study period.
Time frame
16 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov