Gulf War IllnessPhase 2NCT04927338
Study of Bacopa in Gulf War Illness Patients
A Phase 2 study testing BacoMind® (Bacopa monnieri standardized extract) in people with Gulf War Illness, run by Nova Southeastern University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 46 to 78 years
- Conditions the study is for
- Gulf War Illness
- What is being tested?
- BacoMind® (Bacopa monnieri standardized extract)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to Apr 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 46 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Born in years 1942 to1978
- Served in the Gulf War theater for any period between August 1990 and July 1991
- 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:
- 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.
- Able to consent to the study
- 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.
- Agrees to participate in follow-up visits.
Who cannot join
- 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),
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- 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.
- 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:
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nova Southeastern University
Davie, Florida, 33314
Mayra Vidro, MPH, (954) 262-2841, mvidro@nova.edu
Amanpreet Cheema, PhD, (954) 262-2871, acheema@nova.edu
About this study
Official title: Phase II, Placebo-controlled Study of BacoMind® Bacopa Monnieri Standardized Extract in Gulf War Illness
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.
Read the detailed description
This is a study in Gulf War Veterans born between 1946 and 1978 who meet the modified Kansas and Centers for Disease Control and Prevention (CDC) case definitions for Gulf War Illness. This phase II, double-masked, randomized, placebo-controlled, two-arm study will focus on assessing cognitive function as evidence of efficacy of the nutraceutical intervention, Bacopa, on central nervous system symptom management of Gulf War Illness. 170 participants will be randomized 1:1 to receive either 12 weeks of the intervention (Bacopa) or placebo. Participants will be evaluated "remotely" via online assessment tools and telephone interviews, allowing participation from a nationwide catchment area. Primary assessment via the California Verbal Learning Test, Second Edition (CVLT-II) will occur at baseline and 12 weeks, along with laboratory assessments for all participants at baseline, and a self-selected subgroup at 12 weeks. Randomization to the intervention or placebo arms will be stratified by membership in the 12-week follow-up laboratory subgroup and sex. Laboratory draws will be performed at the participant's local clinical laboratory and will allow for measurements of putative biomarkers of neuron health and structural integrity along with biomarkers of inflammation and immune signaling. Monitoring phone calls will be made to the participant biweekly to assess safety. Participants will also undergo subjective assessments of physical health, vitality, sleep, pain, and symptom severity at baseline, 6, 12, and 16 weeks. Thus, participants will be observed through the treatment period (12 weeks) and for 4 weeks after completion to assess immediate effects and durability of the response.
- Conditions
- Gulf War Illness
- Being tested
- BacoMind® (Bacopa monnieri standardized extract), Placebo
- Keywords
- Veterans, Gulf War Illness, Nutraceutical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BacoMind® (Bacopa monnieri standardized extract)Dietary supplement
Also called Bacopa, Bacopa monnieri
BacoMind® (Bacopa monnieri standardized extract) 300 mg daily capsule.
PlaceboDrug
Daily placebo capsule identical in size, color, and shape to that of the Bacopa capsules.
| Study group | Role | What they receive |
|---|---|---|
| BacoMind® 300mg/day | Experimental | Participants randomized to the experimental arm will receive 12 weeks of 300 mg/day BacoMind® Bacopa monnieri standardized extract. Receives: Dietary Supplement: BacoMind® (Bacopa monnieri standardized extract) |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (4)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 16 weeks
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start1 Dec 2022
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gulf War IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double-blinded, two-arm, placebo-controlled, randomized phase II study in 170 participants born between 1946 and 1978 who are Gulf War Veterans and meet the modified Kansas and Centers for Disease Control and Prevention (CDC) case definition for Gulf War Illness.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- RTI International, Boston University
- Responsible party
- Principal investigator, Amanpreet Cheema, Nova Southeastern University
- Investigators
- Amanpreet Cheema, PhD, Principal investigator, Nova Southeastern Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927338
- Sponsor's protocol ID
- GWICTIC-Bacopa
- Other IDs
- W81XWH1820062
- Status last verified
- Jul 2025
- First submitted
- 7 Jun 2021
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The plan is to release primary results from the study to ClinicalTrials.gov. Data are the property of Nova Southeastern University, but data and publication thereof will not be unduly withheld. Those interested in Bacopa data should reach out to Amanpreet Cheema (PI) for more information.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Placebo-controlled Study of BacoMind® Bacopa Monnieri Standardized Extract in Gulf War Illness
- ClinicalTrials.gov ID
- NCT04927338
- Acronym / sponsor ID
- GWICTIC-Bacopa
- Conditions
- Gulf War Illness
- Keywords
- Veterans, Gulf War Illness, Nutraceutical
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Collaborators
- RTI International, Boston University
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 16 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a study in Gulf War Veterans born between 1946 and 1978 who meet the modified Kansas and Centers for Disease Control and Prevention (CDC) case definitions for Gulf War Illness. This phase II, double-masked, randomized, placebo-controlled, two-arm study will focus on assessing cognitive function as evidence of efficacy of the nutraceutical intervention, Bacopa, on central nervous system symptom management of Gulf War Illness. 170 participants will be randomized 1:1 to receive either 12 weeks of the intervention (Bacopa) or placebo. Participants will be evaluated "remotely" via online assessment tools and telephone interviews, allowing participation from a nationwide catchment area. Primary assessment via the California Verbal Learning Test, Second Edition (CVLT-II) will occur at baseline and 12 weeks, along with laboratory assessments for all participants at baseline, and a self-selected subgroup at 12 weeks. Randomization to the intervention or placebo arms will be stratified by membership in the 12-week follow-up laboratory subgroup and sex. Laboratory draws will be performed at the participant's local clinical laboratory and will allow for measurements of putative biomarkers of neuron health and structural integrity along with biomarkers of inflammation and immune signaling. Monitoring phone calls will be made to the participant biweekly to assess safety. Participants will also undergo subjective assessments of physical health, vitality, sleep, pain, and symptom severity at baseline, 6, 12, and 16 weeks. Thus, participants will be observed through the treatment period (12 weeks) and for 4 weeks after completion to assess immediate effects and durability of the response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a double-blinded, two-arm, placebo-controlled, randomized phase II study in 170 participants born between 1946 and 1978 who are Gulf War Veterans and meet the modified Kansas and Centers for Disease Control and Prevention (CDC) case definition for Gulf War Illness.
| Arm | Type | Receives |
|---|---|---|
| BacoMind® 300mg/day | Experimental | Dietary Supplement: BacoMind® (Bacopa monnieri standardized extract)Participants randomized to the experimental arm will receive 12 weeks of 300 mg/day BacoMind® Bacopa monnieri standardized extract. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants randomized to the placebo arm will receive 12 weeks of daily placebo identical to the experimental treatment in size, color, and shape. |
Who may qualify
- Ages
- 46 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Born in years 1942 to1978
- Served in the Gulf War theater for any period between August 1990 and July 1991
- 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:
- Able to consent to the study
- 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.
Key exclusion criteria (22 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BacoMind® (Bacopa monnieri standardized extract)Also: Bacopa, Bacopa monnieriBacoMind® (Bacopa monnieri standardized extract) 300 mg daily capsule. | Dietary supplement | BacoMind® 300mg/day |
| PlaceboDaily placebo capsule identical in size, color, and shape to that of the Bacopa capsules. | Drug | Placebo |
Primary outcome
California Verbal Learning Test (CVLT-II) Assessment
Time frame: 12 weeks
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.
4 secondary outcomes
Blood Biomarker Concentrations
Time frame: 12 weeks
Veterans RAND 36 Item Health Survey (VR-36©)
Time frame: 12 weeks
Veterans RAND 36 Item Health Survey (VR-36©)
Time frame: 16 weeks
Review of Treatment Related Adverse Events
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: No. The plan is to release primary results from the study to ClinicalTrials.gov. Data are the property of Nova Southeastern University, but data and publication thereof will not be unduly withheld. Those interested in Bacopa data should reach out to Amanpreet Cheema (PI) for more information.
Related trials for Gulf War Illness
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amanpreet Cheema, PhD principal investigator
Nova Southeastern Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BacoMind® (Bacopa monnieri standardized extract) in people with Gulf War Illness, run by Nova Southeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mayra Vidro, MPH (954-262-2841, mvidro@nova.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
California Verbal Learning Test (CVLT-II) Assessment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.