Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT02865460
Eligibility Criteria:
Inclusion Criteria:
* Male and female Veterans who were deployed in 1990 -1991 Gulf War.
* Veterans who currently meet the Kansas Gulf War Study Case Definition for Gulf War Illness.
* Veterans who were in good health based on medical history prior to 1990.
* Veterans whose severity of illness is moderate to severe, evidenced by scoring less than 30 of 100 on the physical domain of SF36.
Exclusion Criteria:
* Veteran has a condition that may interfere with the ability to accurately report symptoms, such as:
* severe psychiatric problems
* schizophrenia
* bipolar disorder
* major depression with psychotic or melancholic features
* delusional disorders alcohol or drug dependence requiring hospitalization, or regular illegal drug use or other psychiatric condition requiring inpatient stay in the 6 months prior to study entry.
* Has dementias of any type
* Currently does not have exclusionary conditions that could reasonably be responsible for the symptoms in multi-symptom disorders, as determined by Investigator (based on Reeves et al.2003).
* Is pregnant or breastfeeding or plans to become pregnant within the next 6 months.
* Medical conditions excluded:
* organ failure
* defined rheumatologic inflammatory disorders
* chronic active infections such as HIV, hepatitis B and C, or transplant
* primary sleep disorders
* Medications that could potentially impact immune function excluded:
* steroids
* immune-suppressives
* nutraceuticals that are formulated to impact mitochondrial function or oxidative stress
* Biologic response modifiers within 3 months of study entry.
* Current use of Coumadin (given the vitamin K structural similarity of CoQ10)
* Known allergy to CoQ10 and/or inactive ingredients of active and placebo soft gelatin capsules
* Willingness to have 12 weeks of washout of current CoQ10, ubiquinol, or ubiquinone supplements will be required between the screening and baseline visits.
* Common multivitamin preparations will be allowed if taken without change throughout the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
70 Years
Study:
NCT02865460
Study Brief:
Protocol Section:
NCT02865460