Thermal Clinic Treatment in Gulf War Illness

Study Details

Brief summary:

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.

Conditions

Posttraumatic Stress Disorder

Study ID

NCT02293291

Start date

Sep, 2014

Status verified date

Jun, 2015

Completion date

Oct, 2016

Anticipated

Primary completion date

Feb, 2016

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 5.0.0. \[2003\]) 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

Exclusion Criteria:

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Lithium Water

To empirically test the effects of Lithium water in violence prevention program on rates of violent attitudes and behavioral inclinations in populations whose drinking water supplies contain little or no lithium.

To utilize an experimental design to establish statistical support for the impact of community habits related variables (protective factors) on violent attitudes and behavioral inclinations among at-risk communities To demonstrate the effect of drinking water variables (protective factors) to existing evidence-based factors (risk factors) that have proven effective in reducing violence based on previous research.

placebo comparator: MIneral water

To empirically test the effects of Lithium water in violence prevention program on rates of violent attitudes and behavioral inclinations in populations whose drinking water supplies contain little or no lithium.

To utilize an experimental design to establish statistical support for the impact of community habits related variables (protective factors) on violent attitudes and behavioral inclinations among at-risk communities To demonstrate the effect of drinking water variables (protective factors) to existing evidence-based factors (risk factors) that have proven effective in reducing violence based on previous research.

Interventions

Lithium Water

To empirically test the effects of Lithium water in violence prevention program on rates of violent attitudes and behavioral inclinations in populations whose drinking water supplies contain little or no lithium.

To utilize an experimental design to establish statistical support for the impact of community habits related variables (protective factors) on violent attitudes and behavioral inclinations among at-risk communities To demonstrate the effect of drinking water variables (protective factors) to existing evidence-based factors (risk factors) that have proven effective in GWI

Primary outcome measure

Number of veterans (GWI) with positive response to lithium water therapy [ Time Frame: 52 weeks ]

Central Contacts and Locations

Central contacts

Garis Silega, MD

9737714679 drsilega@aol.com

Locations

Gaviota Clinic

Recruiting

Newark, New Jersey, United States, 07105

Contacts

Garis Silega, MD

973-771-4679 drsilega@aol.com

Thermal ClinicThermal Clinic Treatment in Gulf War Illness

Study Details

Eligibility Criteria

Study Design

Interventions and Outcome Measures

Central Contacts and Locations

More Information