RECRUITING

Study of Bacopa in Gulf War Illness Patients

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase II, Placebo-controlled Study of BacoMind® Bacopa Monnieri Standardized Extract in Gulf War Illness

Quick Facts

Study Start:2022-12-01

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04927338

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:46 Years to 78 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 War Illness (GWI). The modified Kansas definition, which includes the CDC criteria includes: 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. 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. 4. Able to consent to the study 5. 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. 6. Agrees to participate in follow-up visits.	1. 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, 2. 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), 3. 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), 4. Renal disease (self-report; laboratory results: renal insufficiency with serum creatinine \> 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 of normal (ULN)). Participants with Gilberts syndrome are eligible for the study if other 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 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. 8. 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) 9. 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 10. 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, 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).

Inclusion Criteria

Exclusion 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 War Illness (GWI). The modified Kansas definition, which includes the CDC criteria includes:
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.
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.
4. Able to consent to the study
5. 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.
6. Agrees to participate in follow-up visits.

1. 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,
2. 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),
3. 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),
4. Renal disease (self-report; laboratory results: renal insufficiency with serum creatinine \> 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 of normal (ULN)). Participants with Gilberts syndrome are eligible for the study if other 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 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.
8. 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)
9. 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
10. 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,
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).

Contacts and Locations

Study Contact

Mayra Vidro, MPH

CONTACT

954-262-2841

mvidro@nova.edu

Karen Kesler, PhD

CONTACT

919-485-1429

kkesler@rti.org

Principal Investigator

Amanpreet Cheema, PhD

PRINCIPAL_INVESTIGATOR

Nova Southeastern Univeristy

Study Locations (Sites)

Nova Southeastern University

Davie, Florida, 33314

United States

Collaborators and Investigators

Sponsor: Nova Southeastern University

Amanpreet Cheema, PhD, PRINCIPAL_INVESTIGATOR, Nova Southeastern Univeristy

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-01

Study Completion Date2025-09

Study Record Updates

Study Start Date2022-12-01

Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

Veterans
Gulf War Illness
Nutraceutical

Additional Relevant MeSH Terms

Gulf War Illness