Pycnogenol (French Maritime Pine Bark) for the Treatment of Gulf War Illness
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Physical Functioning Score of the Veterans Rand 12-Item Health Survey
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This study is single-blind, participants will not know when they received placebo or pycnogenol. There are also four possible dosages for pycnogenol. Participants will also receive placebo (capsules with an inactive substance) at some point during the treatment phase of the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Currently involved in another experimental treatment study
- •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.)
- •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.
研究组 & 干预措施
Participants Receiving Botanicals
Participants Receiving Botanicals
干预措施: Placebo (Other)
Participants Receiving Botanicals
Participants Receiving Botanicals
干预措施: Pycnogenol, 100mg (Dietary Supplement)
Participants Receiving Botanicals
Participants Receiving Botanicals
干预措施: Pycnogenol, 200mg (Dietary Supplement)
Participants Receiving Botanicals
Participants Receiving Botanicals
干预措施: Pycnogenol, 400mg (Dietary Supplement)
Participants Receiving Botanicals
Participants Receiving Botanicals
干预措施: Pycnogenol, 600mg (Dietary Supplement)
结局指标
主要结局
Change in Physical Functioning Score of the Veterans Rand 12-Item Health Survey
时间窗: 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
时间窗: 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 Physical Functioning Score of the VR-12
时间窗: 12 months
This change will be measured using weekly surveys (ADD THE ACTUAL SCALE)
Change in Mental Functioning Score of the VR-12
时间窗: 12 months
This change will be measured using weekly surveys (ADD THE ACTUAL SCALE)
次要结局
未报告次要终点
研究者
Jarred Younger
Professor
University of Alabama at Birmingham