Pycnogenol for Gulf War Syndrome

JY
Overseen ByJarred Younger, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how pycnogenol, a plant extract, might ease symptoms of Gulf War Illness (GWI), such as fatigue, pain, and cognitive difficulties. Researchers aim to determine if pycnogenol can safely reduce inflammation in the body and brain, believed to cause GWI symptoms. Those who have completed previous trials with botanicals like curcumin and continue to experience GWI symptoms might find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research on relieving GWI symptoms.

What prior data suggests that pycnogenol is safe for treating Gulf War Illness?

Research has shown that Pycnogenol, a natural extract from French maritime pine bark, is generally safe for people with Gulf War Illness (GWI). In past studies, participants who took Pycnogenol reported fewer symptoms than those on a placebo, suggesting it might help reduce inflammation that causes tiredness, pain, and cognitive issues in GWI.

Importantly, serious side effects have not been commonly reported with Pycnogenol. Some individuals have experienced mild issues, like an upset stomach, but these are rare. Since this treatment uses a natural extract, it is usually considered safe for most people. However, consulting a doctor before joining a trial is always important to ensure it's appropriate.12345

Why are researchers excited about this trial?

Researchers are excited about Pycnogenol for treating Gulf War Syndrome because it's a natural extract derived from the bark of the French maritime pine tree. Unlike typical treatments for this condition, which often focus on managing symptoms with medications like pain relievers and antidepressants, Pycnogenol is thought to work through its antioxidant and anti-inflammatory properties. This means it might address the underlying oxidative stress and inflammation believed to contribute to the syndrome, potentially providing relief without the side effects common in standard pharmaceuticals.

What evidence suggests that pycnogenol might be an effective treatment for Gulf War Illness?

Research has shown that Pycnogenol, an extract from pine bark, might help ease symptoms of Gulf War Illness (GWI). In one study, participants who took Pycnogenol reported feeling much better than those who took a placebo, a pill with no active ingredients. Symptoms that improved included tiredness, pain, and thinking problems, often linked to inflammation. Pycnogenol is believed to reduce inflammation, which might explain its effectiveness in managing GWI. This trial will evaluate Pycnogenol as a potential option for managing GWI symptoms.34567

Who Is on the Research Team?

JY

Jarred Younger, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for individuals with Gulf War Illness, characterized by chronic symptoms like fatigue, pain, and cognitive issues. Participants should have a history of service in the Gulf War and meet specific criteria that confirm a diagnosis of GWI.

Inclusion Criteria

Able to commit to a 12-month study
Meet the Kansas GWI case definition
Meet the CDC GWI case definition
See 1 more

Exclusion Criteria

Currently involved in another experimental treatment study
Currently pregnant
I am not taking any medications that are not allowed in the study, such as blood thinners, lithium, certain cancer drugs, daily aspirin, nitroglycerin, or if I have low blood pressure or need surgery soon.
See 2 more

Timeline for a Trial Participant

Baseline

Participants complete weekly questionnaires about symptom severity ratings without taking any capsules

4 weeks
Remote participation

Treatment

Participants take capsules twice daily and complete weekly questionnaires about GWI symptoms

40 weeks
Remote participation

End line

Participants complete weekly symptom measures without taking capsules

4 weeks
Remote participation

Follow-up

Participants are informed about placebo and treatment dosages received and shown GWI severity changes over time

4 weeks
Remote participation

What Are the Treatments Tested in This Trial?

Interventions

  • Pycnogenol
Trial Overview The study tests Pycnogenol at different doses (100mg to 600mg) against a placebo to see if it can reduce symptoms of Gulf War Illness by targeting inflammation. The goal is also to find the safest and most effective dosage.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Participants Receiving BotanicalsExperimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Citations

Pycnogenol® Pine Bark Extract in Clinical StudiesThe symptoms of gulf war illness after intake of Pycnogenol® were significantly reduced compared to placebo. ... Efficacy in a randomised trial.
Gulf War IllnessDATA SUPPLEMENT. Table 9. Results for physical health, pain, and fatigue outcomes in intervention trials for Gulf War Illness. Intervention and study ...
Dysregulation of cellular energetics in Gulf War IllnessThe available clinical and pre-clinical data suggest that agents that improve mitochondrial function have the potential to restore cellular energetics and treat ...
GWIRP Landscape• Effectiveness of Acupuncture in the Treatment of Gulf War Illness ... perpetuation of complex chronic illness: Gulf War illness and chronic fatigue syndrome.
A Placebo-Controlled, Pseudo-Randomized, Crossover ...Boswellia was not more effective than placebo at reducing GWI symptoms at either the lower (p = 0.726) or higher (p = 0.869) dosages. Maritime ...
Pycnogenol (French Maritime Pine Bark) for the Treatment ...The purpose of this research study is to determine how pycnogenol may reduce Gulf War Illness (GWI) symptom severity.
A Placebo-Controlled, Pseudo-Randomized, Crossover Trial ...This report is part of a larger study designed to rapidly and efficiently screen potential treatments for Gulf War Illness (GWI) by testing ...
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