Pycnogenol (French Maritime Pine Bark) for the Treatment of Gulf War Illness
NCT ID: NCT07266571
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2026-02-01
2027-02-01
Brief Summary
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Detailed Description
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The first stage of the study is the baseline phase. During this time, participants will complete weekly questionnaires about symptom severity ratings but will not take any capsules. The baseline stage will last for 30 days.
After the 30-day baseline, the treatment stage will begin. Capsules will be taken once in the morning, and once before bed. This study is single-blind, meaning that participants will not know when placebo or pycnogenol are received. There are also four possible dosages for pycnogenol.
The capsules will be packaged to indicate the order in which they should be taken. The capsules will be packaged in blister packs and shipped to participants. The capsules are designed to look the same throughout the study, though the contents can change. This treatment stage is the longest, lasting 10 months.
During the treatment stage, participants will also be asked to complete weekly questionnaires about GWI symptoms. These weekly questionnaires will also ask about changes in symptoms and overall quality of life, as well as changes in physical and mental health. Questionnaires can be completed on a smartphone, computer, or tablet. If participants do not have an appropriate device, or do not want to use your personal device, a tablet can be sent for the study. A research team member will speak with participants to set up electronic device connections and will verify the information is received.
At the end of the treatment stage, participants will stop taking capsules and will complete the end line stage. This stage is the same as the baseline stage in which participants will complete weekly symptom measures without taking capsules. This stage will last for 30 days.
After completion of the study, participants will be told when placebo was received, and what dosage(s) of treatment were received. Participants will also be shown how GWI severity changes over time.
While this study is long, it is designed to not be a significant burden to daily life. On most days, participation (taking morning capsules, taking evening capsules, and completing weekly symptom severity reports) should take approximately 2 minutes.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Participants Receiving Botanicals
Participants Receiving Botanicals
Placebo
The placebo being used in this study is microcrystalline cellulose. This will be taken orally, up to twice per day.
Pycnogenol, 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.
Pycnogenol, 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.
Pycnogenol, 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.
Pycnogenol, 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.
Interventions
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Placebo
The placebo being used in this study is microcrystalline cellulose. This will be taken orally, up to twice per day.
Pycnogenol, 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.
Pycnogenol, 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.
Pycnogenol, 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.
Pycnogenol, 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Meet the CDC GWI case definition
* Able to commit to a 12-month study
* 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 pregnant
* Have a blood clotting disorder
* Reported diagnosis of diabetes with a A1C greater than 9
* Use of contraindicated medications (see below):
* Anticoagulants (such as warfarin, heparin, etc.)
* Lithium
* Tacrolimus (Prograf)
* Cancer medications (Alkylating agents, antitumor antibiotics, Topoisomerase I inhibitors, Tamoxifen)
* Daily Use of Antiplatelet agents (e.g. aspirin, clopidogrel)
* Nitroglycerin
* Hypotension
* Need for surgery during study period.
18 Years
ALL
No
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Jarred Younger
Professor
Principal Investigators
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Jarred Younger, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UAB
Identifier Type: OTHER
Identifier Source: secondary_id
30015456
Identifier Type: -
Identifier Source: org_study_id
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