Gulf War SyndromeNCT07266571
Pycnogenol (French Maritime Pine Bark) for the Treatment of Gulf War Illness
A study testing Pycnogenol, 100mg, Pycnogenol, 200mg and Pycnogenol, 400mg in people with Gulf War Syndrome, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Gulf War Syndrome
- What is being tested?
- Pycnogenol, 100mg, Pycnogenol, 200mg and Pycnogenol, 400mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 (such as warfarin, heparin, etc.)
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35243
Jarred Younger, PhD, 205-975-5821, youngerlab@uab.edu
Jarred Younger, PhD
About this study
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.
Read the detailed 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 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 a 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
- Gulf War Syndrome
- Being tested
- Placebo, Pycnogenol, 100mg, Pycnogenol, 200mg, Pycnogenol, 400mg, Pycnogenol, 600mg
- Keywords
- Gulf War Illness, Pycnogenol, Botanical, French Maritime Pine Bark
- Medical subject headings
- Persian Gulf Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Also called Microcrystalline Cellulose
The placebo being used in this study is microcrystalline cellulose. This will be taken orally, up to twice per day.
Pycnogenol, 100mgDietary supplement
Also called French Maritime Pine Bark
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, 200mgDietary supplement
Also called French Maritime Pine Bark
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, 400mgDietary supplement
Also called French Maritime Pine Bark
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, 600mgDietary supplement
Also called French Maritime Pine Bark
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants Receiving Botanicals | Experimental | Participants Receiving Botanicals Receives: Other: Placebo; Dietary Supplement: Pycnogenol, 100mg; Dietary Supplement: Pycnogenol, 200mg; Dietary Supplement: Pycnogenol, 400mg; Dietary Supplement: Pycnogenol, 600mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gulf War SyndromeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jarred Younger, University of Alabama at Birmingham
- Investigators
- Jarred Younger, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266571
- Sponsor's protocol ID
- IRB-30015456
- Other IDs
- UAB
- Status last verified
- Sep 2026
- First submitted
- 24 Nov 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pycnogenol (French Maritime Pine Bark) for the Treatment of Gulf War Illness
- ClinicalTrials.gov ID
- NCT07266571
- Acronym / sponsor ID
- IRB-30015456
- Conditions
- Gulf War Syndrome
- Keywords
- Gulf War Illness, Pycnogenol, Botanical, French Maritime Pine Bark
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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 a 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Receiving Botanicals | Experimental | Other: Placebo, Dietary Supplement: Pycnogenol, 100mg, Dietary Supplement: Pycnogenol, 200mg, Dietary Supplement: Pycnogenol, 400mg, Dietary Supplement: Pycnogenol, 600mgParticipants Receiving Botanicals |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (13 listed)
- 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):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Microcrystalline CelluloseThe placebo being used in this study is microcrystalline cellulose. This will be taken orally, up to twice per day. | Other | Participants Receiving Botanicals |
| Pycnogenol, 100mgAlso: French Maritime Pine BarkPycnogenol 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 supplement | Participants Receiving Botanicals |
| Pycnogenol, 200mgAlso: French Maritime Pine BarkPycnogenol 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 supplement | Participants Receiving Botanicals |
| Pycnogenol, 400mgAlso: French Maritime Pine BarkPycnogenol 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 supplement | Participants Receiving Botanicals |
| Pycnogenol, 600mgAlso: French Maritime Pine BarkPycnogenol 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 supplement | Participants Receiving Botanicals |
Primary outcome
Change in Physical Functioning Score of the Veterans Rand 12-Item Health Survey
Time frame: 12 months
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.
Change in Mental Functioning Score of the Veterans Rand 12-Item Health Survey
Time frame: 12 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Gulf War Syndrome
RecruitingPhase 1
Clinical Evaluation of Montelukast in Veterans With Gulf War Illness
Gulf War Syndrome
Recruiting
Mechanisms of Gulf War Illness
Gulf War Illness, Irritable Bowel Syndrome
RecruitingPhase 2
Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT)
Gulf War Syndrome, Adult Growth Hormone Deficiency
RecruitingPhase 2
Resistant Potato Starch to Alleviate GWI
Gulf War Illness
RecruitingPhase 3
Coenzyme Q10 for Gulf War Illness: A Replication Study
Gulf War Syndrome, Persian Gulf Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jarred Younger, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pycnogenol, 100mg, Pycnogenol, 200mg and Pycnogenol, 400mg in people with Gulf War Syndrome, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jarred Younger, PhD (205-975-5821, youngerlab@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Functioning Score of the Veterans Rand 12-Item Health Survey (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.