Pycnogenol (French Maritime Pine Bark) for the Treatment of Gulf War Illness

The University of Alabama at Birmingham

Status

Not yet enrolling

Conditions

Gulf War Syndrome

Treatments

Dietary Supplement: Pycnogenol, 100mg

Dietary Supplement: Pycnogenol, 200mg

Dietary Supplement: Pycnogenol, 600mg

Dietary Supplement: Pycnogenol, 400mg

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT07266571

30015456

UAB (Other Grant/Funding Number)

Details and patient eligibility

About

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. We 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.

Full description

This study uses a decentralized design where individuals can participate from anywhere in the United States. 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 nationwide, with a total of 20 participants enrolled for the entire study. Participation will last 12 months.

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Meet the Kansas GWI case definition
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 involved in another experimental treatment study
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.