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Trial record 6 of 6 for:    olibanum

Effects of Botanical Microglia Modulators in Gulf War Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02909686
Recruitment Status : Active, not recruiting
First Posted : September 21, 2016
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
Congressionally Directed Medical Research Programs
Information provided by (Responsible Party):
Jarred Younger, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE September 13, 2016
First Posted Date  ICMJE September 21, 2016
Last Update Posted Date August 20, 2019
Actual Study Start Date  ICMJE July 2016
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2016)
Change from baseline in overall Gulf War Illness disease severity [ Time Frame: 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. ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02909686 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2016)
  • Change from baseline in Pain Severity [ Time Frame: 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. ]
    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).
  • Change from baseline in Fatigue Severity [ Time Frame: 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. ]
    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).
  • Change from baseline in Cognitive Symptom Severity [ Time Frame: 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. ]
    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).
  • Change from baseline in Mood Symptom Severity [ Time Frame: 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. ]
    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]).
  • Change from baseline in Dermatological Symptom Severity [ Time Frame: 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. ]
    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).
  • Change from baseline in Respiratory Symptom Severity [ Time Frame: 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. ]
    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).
  • Change from baseline in Gastrointestinal Symptom Severity [ Time Frame: 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. ]
    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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Botanical Microglia Modulators in Gulf War Illness
Official Title  ICMJE Effects of Botanical Microglia Modulators in Gulf War Illness
Brief 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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Gulf War Illness
Intervention  ICMJE
  • Dietary Supplement: Boswellia Serrata
    Other Name: Indian frankincense
  • Dietary Supplement: Curcumin
    Other Names:
    • Curcumasorb
    • Turmeric extract
    • Meriva
  • Dietary Supplement: Epimedium
    Other Names:
    • Barrenwort
    • Bishop's Hat
    • Fairy Wings
    • Horny Goat Weed
    • Yin Yang Huo
  • Dietary Supplement: Fisetin
  • Dietary Supplement: Luteolin
  • Dietary Supplement: Nettle
    Other Names:
    • Common Nettle
    • urtica dioica
    • Stinging Nettle
  • Dietary Supplement: Pycnogenol
    Other Names:
    • Maritime Pine Extract
    • Pine Bark Extract
  • Dietary Supplement: Reishi Mushroom
  • Dietary Supplement: Resveratrol
    Other Name: Red Wine Extract
  • Dietary Supplement: Placebo
Study Arms  ICMJE
  • Experimental: Boswellia Serrata
    400-800mg in capsule form by mouth every day
    Intervention: Dietary Supplement: Boswellia Serrata
  • Experimental: Curcumin
    1000-2000mg in capsule form by mouth every day
    Intervention: Dietary Supplement: Curcumin
  • Experimental: Epimedium
    1000-2000mg in capsule form by mouth every day
    Intervention: Dietary Supplement: Epimedium
  • Experimental: Fisetin
    200-800mg in capsule form by mouth every day
    Intervention: Dietary Supplement: Fisetin
  • Experimental: Luteolin
    200-400mg in capsule form by mouth every day
    Intervention: Dietary Supplement: Luteolin
  • Experimental: Nettle
    435-1305mg in capsule form by mouth every day
    Intervention: Dietary Supplement: Nettle
  • Experimental: Pycnogenol
    200-400mg in capsule form by mouth every day
    Intervention: Dietary Supplement: Pycnogenol
  • Experimental: Reishi Mushroom
    1600-3200mg in capsule form by mouth every day
    Intervention: Dietary Supplement: Reishi Mushroom
  • Experimental: Resveratrol
    200-600mg in capsule form by mouth every day
    Intervention: Dietary Supplement: Resveratrol
  • Placebo Comparator: Placebo
    in capsule form by mouth every day
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 6, 2018)
64
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2016)
40
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 39 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02909686
Other Study ID Numbers  ICMJE F150318011
CDMRP-GW130015 ( Other Grant/Funding Number: Congressionally Directed Medical Research Programs )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jarred Younger, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Congressionally Directed Medical Research Programs
Investigators  ICMJE
Principal Investigator: Jarred W Younger, PhD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP