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Herbal Supplement
Bacopa for Gulf War Syndrome
Phase 2
Recruiting
Led By Amaanpreet Cheema, PhD
Research Sponsored by Nova Southeastern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Born in years 1946 to 1974
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
Study Summary
This trial will test whether a natural supplement can help improve symptoms of Gulf War Illness, which causes a range of problems like fatigue, memory difficulties, and joint pain.
Who is the study for?
This trial is for Gulf War veterans born between 1946-1974 who served in the theater from Aug 1990 to Jul 1991. They must meet criteria for Gulf War Illness, have stable chronic conditions like hypertension or PTSD, and not require hospitalization recently. Participants should not be heavy drinkers/smokers, pregnant, or have severe organ diseases.Check my eligibility
What is being tested?
The study tests Bacopa monnieri extract (BacoMind®) against a placebo to see if it improves cognitive function in patients with Gulf War Illness. It's a phase II trial where participants are randomly assigned to either the supplement group or placebo group without knowing which one they're receiving.See study design
What are the potential side effects?
While specific side effects of Bacopa are not listed here, common ones may include stomach upset, dry mouth, increased bowel movements and fatigue. As this is a natural supplement being tested for safety as well as efficacy, unexpected side effects could occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was born between 1946 and 1974.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
California Verbal Learning Test (CVLT-II) Assessment
Secondary outcome measures
Blood Biomarker Concentrations
Review of Treatment Related Adverse Events
Veterans RAND 36 Item Health Survey (VR-36©)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BacoMind® 300mg/dayExperimental Treatment1 Intervention
Participants randomized to the experimental arm will receive 12 weeks of 300 mg/day BacoMind® Bacopa monnieri standardized extract.
Group II: PlaceboPlacebo Group1 Intervention
Participants randomized to the placebo arm will receive 12 weeks of daily placebo identical to the experimental treatment in size, color, and shape.
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Who is running the clinical trial?
Nova Southeastern UniversityLead Sponsor
89 Previous Clinical Trials
11,377 Total Patients Enrolled
2 Trials studying Gulf War Syndrome
330 Patients Enrolled for Gulf War Syndrome
RTI InternationalOTHER
188 Previous Clinical Trials
875,700 Total Patients Enrolled
1 Trials studying Gulf War Syndrome
170 Patients Enrolled for Gulf War Syndrome
Boston UniversityOTHER
454 Previous Clinical Trials
9,941,306 Total Patients Enrolled
3 Trials studying Gulf War Syndrome
430 Patients Enrolled for Gulf War Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a bleeding disorder or I'm currently using blood thinners, except for low-dose NSAIDs.I have not been treated for major depression with specific features, schizophrenia, bipolar, delusional disorders, dementia, or substance abuse in the last two years.I don't have any other health conditions that could explain my extreme tiredness.I have not used Bacopa in the last 6 weeks.My kidney function is low, with high creatinine or I'm on dialysis.I have had surgery recently or am scheduled for one during the study.I was born between 1946 and 1974.My liver isn't working well, with high bilirubin or enzyme levels.
Research Study Groups:
This trial has the following groups:- Group 1: BacoMind® 300mg/day
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any harmful side effects associated with BACOPA?
"While there is some data supporting BACOPA's safety, none of it indicates that the medication is effective. Therefore, it received a score of 2."
Answered by AI
Are new test subjects being actively sought for this experiment?
"Unfortunately, this specific study is not looking for any more participants at the moment. However, there are 13 other trials that might be of interest and are currently recruiting patients."
Answered by AI
Can minors participate in this research?
"The target population for this research are individuals that fall between 45 to 70 years old."
Answered by AI
Are there any specific requirements in order to join this research project?
"To qualify for this specific trial, applicants must have gulf war syndrome and be between the ages of 45-70. There are approximately 264 places available in the study."
Answered by AI
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