Health TrialsbyHealthPanel

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

ConditionGulf War Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Meet the Kansas GWI case definition

Meet the CDC GWI case definition

Able to commit to a 12-month study

Male

Disqualifiers

Currently involved in another experimental treatment study

Female

Have a blood clotting disorder

Reported diagnosis of diabetes with a A1C greater than 9

Trial design

Design model

Single group

Treatments tested in this trial

  • Placebo

    Other intervention

    The placebo being used in this study is microcrystalline cellulose. This will be taken orally, up to twice per day.

  • Pycnogenol, 100mg

    Dietary supplement

    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

    Dietary supplement

    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

    Dietary supplement

    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

    Dietary supplement

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Participants Receiving BotanicalsExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Change in Physical Functioning Score of the Veterans Rand 12-Item Health Survey

This change will be measured using weekly surveys. Veterans Rand 12-Item Health Survey scores are standardized to a mean of 50 (SD = 10), with higher scores indicating better functioning; scores theoretically range from approximately 0 to 100.

Time frame
12 months
2

Change in Mental Functioning Score of the Veterans Rand 12-Item Health Survey

This change will be measured using weekly surveys. Veterans Rand 12-Item Health Survey scores are standardized to a mean of 50 (SD = 10), with higher scores indicating better functioning; scores theoretically range from approximately 0 to 100.

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: