Thermal Clinic Treatment in Gulf War Illness
试验速览
- 阶段
- 1 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of veterans (GWI) with positive response to lithium water therapy
研究概览
简要总结
Although thermal therapy has been utilized in the rehabilitation of war veterans since the Roman Empire, no investigations actually exist about the use of thermal therapy in GWI, This due to the fact that nobody knows that the cure for the syndrome in GWI veterans may exist in thermal therapy which is the primary objective of this investigation.
详细描述
Gulf War illness (GWI) refers to the complex of symptoms that affects veterans of the 1990-1991 Gulf War at significantly excess rates. It is characterized by multiple diverse symptoms not explained by established medical diagnoses or standard laboratory tests, symptoms that typically include a combination of memory and concentration problems, persistent headache, unexplained fatigue, and widespread pain, and can also include chronic digestive difficulties, respiratory symptoms, and skin rashes. A similar profile of excess symptoms has been described in every study of U.S. Gulf War veterans from different regions and units, and in Gulf War veterans from the United Kingdom and other allied countries.
Gulf War illness is not the only health condition related to Gulf War service, but it is by far the most common. Gulf War illness prevalence estimates vary with the specific case definition used. Studies consistently indicate, however, that an excess of 25 to 32 percent of veterans who served in the 1990-1991 Gulf War are affected by a complex of multiple symptoms, variously defined, over and above rates in contemporary military personnel who did not deploy to the Gulf War. That means that between 175,000 and 210,000 of the nearly 700,000 U.S. veterans who served in the 1990-1991 Gulf War suffer from this persistent pattern of symptoms as a result of their wartime service.
Research has not supported early speculation that Gulf War illness is a stress-related condition. Large population-based studies of Gulf War veterans consistently indicate that Gulf War illness is not the result of combat or other deployment stressors, and that rates of posttraumatic stress disorder (PTSD) and other psychiatric conditions are relatively low in Gulf War veterans. Gulf War illness differs fundamentally from trauma and stress-related syndromes that have been described after other wars. No Gulf War illness-type problem, that is, no widespread symptomatic illness not explained by medical or psychiatric diagnoses, has been reported in veterans who served in Bosnia in the 1990s or in current conflicts in Iraq and Afghanistan.
Epidemiologic studies indicate that rates of Gulf War illness vary in different subgroups of Gulf War veterans. Gulf War illness affects veterans who served in the Army and Marines at higher rates than those in the Navy and Air Force, and enlisted personnel more than officers. Studies also indicate that Gulf War illness rates differ according to where veterans were located during deployment, with highest rates among troops who served in forward areas. More specifically, studies consistently show that the rate of Gulf War illness is associated with particular exposures that veterans encountered during deployment.
Identified links between veteran-reported exposures and Gulf War illness have raised a great deal of interest, but have also been the source of considerable confusion. The use of self-reported exposure information raises a number of concerns, most obviously in relation to recall bias. These concerns emphasize the importance of assessing findings across a broad spectrum of studies, rather than relying on results from individual studies, and of evaluating the impact of recall and other information bias on study results where possible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are primarily diagnosed with PTSD (Posttraumatic Stress Disorder: 309.81) using DSM-IV-TR criteria. The CAPS-DX (Clinician-Administered PTSD Scale-DX) and M.I.N.I. (The Mini International Neuropsychiatric Interview, Japanese version 5.0.
- •[2003]) will be used for diagnosis
- •Patients aged 18 and <65 at the time of signing the Informed consent
- •Male and female patients
- •Inpatient/outpatient status: Both are permitted
- •Patients who are able to give written informed consent in person (i.e., patients who are capable of giving written informed consent on their own)
- •Patients whose combined score of the CAPS-SX standard B, C, and D is over 50
排除标准
- •Patients primarily diagnosed with a DSM-IV-TR Axis I disorder other than PTSD (e.g. major depressive disorder, dysthymic disorder, specific phobia [simple phobia], obsessive-compulsive disorder, panic disorder, etc.) within 6 months of week -4 (start of baseline phase)
- •Patients presenting with a current major depressive episode that preceded the diagnosis of PTSD
- •Patients who are pregnant, lactating or of childbearing potential and are likely to become pregnant
- •Patients receiving another investigational product within 12 weeks before Week -4 (start of baseline phase)
- •Patients with a history or complication of manic psychosis
- •Patients with a history or complication of convulsive disorder (epilepsy, etc.)
- •Patients with a diagnosis or complication of a cognitive disorder (MMSE <=24 points)
- •Patients with a history and complication of serious cerebral organic disorder. (e.g. cerebrovascular disorder, meningitis, degenerative disease and other neurological disorders and seizures; however, bleeding in the upper arachnoid membrane should not be excluded)
- •Patients unable or unwilling to undergo the fMRI procedure (e.g., cerebrovascular clipping surgery, pacemaker, any internal metals with magnetism, and claustrophobia)
- •Patients with glaucoma
- •Patients with a known tendency for bleeding or those with predisposing conditions
- •Patients with serious physical symptoms (cardiac, hepatic and renal dysfunction, or hematopoietic dysfunction, etc.). For seriousness, Grade 3 of "Criteria for seriousness of adverse reactions to drugs, etc. (Yakuan No.80)" is used as an index
- •Patients with a history or complication of cancer or malignant tumour
- •Patients with chronic hepatitis type B and/or C which is positive of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody
- •Others whom the investigator or sub-investigator considers ineligible for or unable to participate in the investigation
结局指标
主要结局
Number of veterans (GWI) with positive response to lithium water therapy
时间窗: 52 weeks
General response to Lithium water therapy in veterans from Gulf War
次要结局
未报告次要终点