Thermal Clinic Treatment in Gulf War Illness

NCT02293291 | Unknown Phase 1 DMC

• 1 other identifier: GWI-2014
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Gulf war illness

Outcome Measures

Primary Outcomes (1)

• Number of veterans (GWI) with positive response to lithium water therapy

  General response to Lithium water therapy in veterans from Gulf War

  52 weeks

Study Arms (2)

Lithium Water

ACTIVE COMPARATOR

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.

Dietary Supplement: Lithium Water

MIneral water

PLACEBO COMPARATOR

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.

Dietary Supplement: Lithium Water

Interventions

Lithium Water DIETARY_SUPPLEMENT

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

Also known as: LIWA

Lithium Water; MIneral water

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American Society Of Thermalism And Climatology Inc: lead

Study Sites (1)

Gaviota Clinic

Newark, New Jersey, 07105, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Garis Silega, MD

  America Society of thermalism

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Garis Silega, MD

CONTACT

9737714679; drsilega@aol.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: November 18, 2014
• Study Start: September 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: October 1, 2016
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

US (1)