Pycnogenol (French Maritime Pine Bark) for the Treatment of Gulf War Illness
University of Alabama at Birmingham
Summary
The purpose of this research study is to determine how pycnogenol may reduce Gulf War Illness (GWI) symptom severity. The study will also examine the safety of this treatment and determine the optimal dosage. The investigators believe that GWI involves inflammation in the body and brain that causes fatigue, pain, cognitive disruption, and other symptoms. Botanicals that reduce inflammation may help treat GWI.
Description
This study uses a decentralized design where individuals can participate from anywhere in the Alabama. Botanicals will be received by mail. Participants will also receive placebo (capsules with an inactive substance) during the treatment phase of the study. All participants will have been present in the Persian Gulf between 1990 and August 1991. This study will be tested on GWI participants recruited in Alabama, with a total of up to 20 participants enrolled (to account for potential withdrawals to obtain 10 completed participants) for the entire study. Participation will last 12 months. The…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Meet the Kansas GWI case definition * Meet the CDC GWI case definition * Able to commit to a 12-month study * Male * Participants will be individuals in our Gulf War database who have already completed our other botanical trial, Curcumin, Resveratrol, and Stinging Nettle as Treatments for Gulf War Illness (NCT05377242). Exclusion Criteria: * Currently involved in another experimental treatment study * Female * Have a blood clotting disorder * Reported diagnosis of diabetes with a A1C greater than 9 * Use of contraindicated medications (see below): * Anticoagulants (suc…
Interventions
- OtherPlacebo
The placebo being used in this study is microcrystalline cellulose. This will be taken orally, up to twice per day.
- Dietary SupplementPycnogenol, 100mg
Pycnogenol being used in this study is a commercially available dietary supplement and is classified as food by the FDA instead of a drug. This will be taken orally, up to twice per day.
- Dietary SupplementPycnogenol, 200mg
Pycnogenol being used in this study is a commercially available dietary supplement and is classified as food by the FDA instead of a drug. This will be taken orally, up to twice per day.
- Dietary SupplementPycnogenol, 400mg
Pycnogenol being used in this study is a commercially available dietary supplement and is classified as food by the FDA instead of a drug. This will be taken orally, up to twice per day.
- Dietary SupplementPycnogenol, 600mg
Pycnogenol being used in this study is a commercially available dietary supplement and is classified as food by the FDA instead of a drug. This will be taken orally, up to twice per day.
Location
- University of Alabama at BirminghamBirmingham, Alabama