Gulf War Illness Clinical Trial
Official title:
Curcumin, Resveratrol, and Stinging Nettle as Treatments for Gulf War Illness
This project's objective is to identify effective treatments for Gulf War Illness (GWI). The project tests three potential treatments: curcumin, stinging nettle, and resveratrol. The project uses a decentralized clinical trial (DCT) design in which individuals can participate from anywhere in the United States. Recruitment efforts will be designed to obtain a geographically and demographically diverse study sample.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | June 30, 2026 |
Est. primary completion date | June 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years and older |
Eligibility | Inclusion Criteria: - Meets Kansas GWI Case Definition - Meets CDC GWI Case Definition - Able to commit to a 10-month study Exclusion Criteria: - Currently involved in an experimental treatment study - Abnormal liver function values - Abnormal kidney function values - Currently pregnant - Blood clotting disorder (contraindicated with all three botanicals) - Antiplatelet or anticoagulant medication use (contraindicated with all three botanicals) |
Country | Name | City | State |
---|---|---|---|
United States | The University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham | Congressionally Directed Medical Research Programs |
United States,
Donovan EK, Kekes-Szabo S, Lin JC, Massey RL, Cobb JD, Hodgin KS, Ness TJ, Hangee-Bauer C, Younger JW. A Placebo-Controlled, Pseudo-Randomized, Crossover Trial of Botanical Agents for Gulf War Illness: Curcumin (Curcuma longa), Boswellia (Boswellia serrata), and French Maritime Pine Bark (Pinus pinaster). Int J Environ Res Public Health. 2021 Mar 3;18(5):2468. doi: 10.3390/ijerph18052468. — View Citation
Hodgin KS, Donovan EK, Kekes-Szabo S, Lin JC, Feick J, Massey RL, Ness TJ, Younger JW. A Placebo-Controlled, Pseudo-Randomized, Crossover Trial of Botanical Agents for Gulf War Illness: Resveratrol (Polygonum cuspidatum), Luteolin, and Fisetin (Rhus succedanea). Int J Environ Res Public Health. 2021 Mar 3;18(5):2483. doi: 10.3390/ijerph18052483. — View Citation
Younger J, Donovan EK, Hodgin KS, Ness TJ. A Placebo-Controlled, Pseudo-Randomized, Crossover Trial of Botanical Agents for Gulf War Illness: Reishi Mushroom (Ganoderma lucidum), Stinging Nettle (Urtica dioica), and Epimedium (Epimedium sagittatum). Int J Environ Res Public Health. 2021 Apr 1;18(7):3671. doi: 10.3390/ijerph18073671. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Daily symptom report | The tertiary outcomes cover symptoms frequently endorsed by GWI patients. The items are designed to measure severity in all six GWI symptom domains (fatigue, pain, neurologic, skin, gastrointestinal, and respiratory). They each use a 0-100 scale. The 21 items are overall GWI severity, interference with life, muscle pain, joint pain, numbness or tingling, body tremors, fatigue, depression, stress, anxiety, irritableness/anger, sleep quality, thinking and memory quality, gastrointestinal problems, headaches, physical activity, post-exertional malaise, dizziness or faintness, respiratory issues, vision problems, and skin problems. | 5 minutes per report. This outcome will be assessed weekly, for up to 44 weeks. | |
Primary | Veterans Rand 12-Item Health Survey (VR-12) | This survey yields two scores: physical functioning (PCS) and mental functioning (MCS). These two scores will be tested as separate primary outcomes | 5 minutes per survey. This outcome will be assessed weekly, for up to 44 weeks. | |
Secondary | Patient Global Impression of Change (PGIC) | The Patient Global Impression of Change (PGIC) assesses overall quality of life improvement and is widely used in clinical trials. | 5 minutes per survey. This outcome will be assessed weekly, for up to 44 weeks. | |
Secondary | Number needed to treat (NNT) | The number needed to treat (NNT) is popular in clinical trial research and indicates the expected number of responders when used in the general GWI population. | This outcome will be assessed once, through study completion, an average of 44 weeks. |
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