Effects of Botanical Microglia Modulators in Gulf War Illness

Gulf War Illness Clinical Trial

Official title:

Effects of Botanical Microglia Modulators in Gulf War Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02909686
• Other study ID #: F150318011
• Secondary ID: CDMRP-GW130015
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: September 2022

Study information

• Verified date: March 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall objective of this protocol is to test if Gulf War Illness (GWI) involves chronic inflammation that cannot be measured with typical techniques. The investigators will be observing the effects of nine different botanical compounds (supplements) that are known to suppress inflammation. If one of those supplements helps the symptoms of GWI, it will give the investigators information about what is wrong in people with GWI.

Description:

There is still a poor understanding of the pain, fatigue, and other symptoms that affect approximately 250,000 veterans. The precise mechanism of Gulf War Illness (GWI) is not understood, and there is no targeted treatment for the condition. A current model for GWI points to the central nervous system, immune cells, called microglia that may be hyperactive in patients with GWI. Discovering effective treatments for this disorder is a top priority of GWI research.

Given the investigator's preliminary data, it is suspected that GWI is a form of low-level neuroinflammation that involves hypersensitivity of receptors on microglia. In order to help test that hypothesis, the investigators will be administering supplements that have been shown in vitro or animal in vivo to suppress microglia function in a way that is anti-inflammatory and neuroprotective. If any of these agents suppress symptoms in GWI, it will give the investigators important information about the disease that may allow for creation of better diagnostic tools and treatments in future research studies. Observing the effects of the selected nine anti-inflammatory botanical compounds, in this clinical study, is a strong compliment to the ongoing mechanistic GWI research.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 2022
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 39 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male

2. Age 39-65, inclusive

3. Veterans who meet the Kansas inclusion criteria for GWI

4. Present in Persian Gulf between 1990 and August 1991

5. Patient completes daily report during 2 week baseline period (at least 80% completion rate)

6. Able to receive a venous blood draw

Exclusion Criteria:

1. Positive rheumatoid factor at screening

2. Positive anti-nuclear antibody at screening

3. C-reactive protein> 3mg/L at screening

4. Erythrocyte Sedimentation Rate> 40mm/hr at screening

5. Auto-immune disorder

6. Diagnosed Rheumatologic Condition

7. Major PTSD symptoms

8. Hypotension (under 90/60 mm Hg) or history of cardiovascular disease

9. Antihypertensive, anticoagulant medication, nitroglycerine, lithium medication use

10. Diabetes with Hemoglobin A1C >9%

11. History of anaphylaxis to study botanical compounds

12. Current daily use of opioid medication

13. Hospital Anxiety and Depression Scale, Depression subscale score of 16 or higher at baseline

14. Current litigation of worker's compensation claim

15. Blood or clotting disorder

16. Acute infection (body temperature over 100 degrees F)

17. Current daily use of confounding-anti-inflammatory medication as part of regular medication regimen

18. Individuals that are not able to read & understand English

Related Conditions & MeSH terms

• Gulf War Illness

Intervention

Dietary Supplement:
• Boswellia Serrata

• Curcumin

• Epimedium

• Fisetin

• Luteolin

• Nettle

• Pycnogenol

• Reishi Mushroom

• Resveratrol

• Placebo

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Congressionally Directed Medical Research Programs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in overall Gulf War Illness disease severity	Self reported Gulf War Illness symptom severity reported twice daily, in the morning and evening, for the duration of the study. Single item scored 0-100 (0=no symptoms; 100=severe symptoms).	Average disease severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline.
Secondary	Change from baseline in Pain Severity	Self reported pain severity reported twice daily, in the morning and evening, for the duration of the study. Single item scored 0-100 (0=no pain; 100=severe pain).	Average pain severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline.
Secondary	Change from baseline in Fatigue Severity	Self reported fatigue severity reported twice daily, in the morning and evening, for the duration of the study. Single item scored 0-100 (0=not fatigued at all; 100=severely fatigued).	Average fatigue severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline.
Secondary	Change from baseline in Cognitive Symptom Severity	Self reported cognitive symptom severity reported twice daily, in the morning and evening, for the duration of the study. Single item scored 0-100 (0=not [able to think and remember] clearly at all; 100=[able to think and remember] very clearly).	Average cognitive symptom severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline.
Secondary	Change from baseline in Mood Symptom Severity	Self reported mood symptom severity reported twice daily, in the morning and evening, for the duration of the study. Single item scored 0-100 (0=not good [mood] at all; 100=extremely good [mood]).	Average mood severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline.
Secondary	Change from baseline in Dermatological Symptom Severity	Self reported dermatological symptom severity reported twice daily, in the morning and evening, for the duration of the study. Single item scored 0-100 (0=no skin problems at all; 100=severe skin problems).	Average dermatological symptom severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline.
Secondary	Change from baseline in Respiratory Symptom Severity	Self reported respiratory symptom severity reported twice daily, in the morning and evening, for the duration of the study. Single item scored 0-100 (0=no breathing or respiratory problems at all; 100=severe breathing or respiratory problems).	Average respiratory symptom severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline.
Secondary	Change from baseline in Gastrointestinal Symptom Severity	Self reported gastrointestinal symptom severity reported twice daily, in the morning and evening, for the duration of the study. Single item scored 0-100 (0=no bowel or GI problems at all; 100=severe bowel or GI problems).	Average gastrointestinal symptom severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline.