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Trial · Interventional

Status unknownPhase 1/2Registry data

Glutathione vs. Curcumin Clinical Trial

Short name Glutathione

NCTNCT02848417 (opens ClinicalTrials.gov in a new tab)Other id4987
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 1/2
Enrollment
75 participants (estimated)
Sponsor
South Florida Veterans Affairs Foundation for Research and Education · Fed
Design
Randomized · Double masking
Countries
1 country

United States

Start
Apr 2016
Primary completion
Aug 2019
Completion
Aug 2020 (estimated)
First posted
28 Jul 2016 (estimated)
Last update posted
29 Jan 2020
Conditions
Gulf War Syndrome

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018201920202021
  1. Ph 1/2

    Glutathione

    NCT02848417

    Apr 2016 to est. Aug 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The investigator proposes to perform a phase I/II study comparing two nutraceuticals and placebo that target mediators identified in the investigator's prior dynamic modeling study of Gulf War Illness (GWI). The investigator will repeat the dynamic modeling before treatment and on therapy to assess the modeling and the impact of the interventions on the homeostatic networks that have identified, with an added focus on the glutathione/redox system.

Interventions

  • CurcuminDrug
  • GlutathioneDrug
  • PlaceboOther

Arms3

  • Experimental

    Curcumin

    12 weeks 400mg orally twice a day

  • Experimental

    Liposomal Glutathione

    12 weeks 630mg orally twice a day

  • Experimental

    Placebo Liquid or Capsules

    Placebo liquid for Glutathione 120 ml per/ bottle 420 mg/5 ml Placebo capsules for Curcumin 60 capsules per bottle 400 mg /cap

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Biomarker response to therapy using a VO2 exercise test

    Time frame · 12 weeks

    Registry description

    Goal is that both will prove safe for use in GWI patients

  2. Biomarker response to therapy using cytokine panel

    Time frame · 12 weeks

    Registry description

    Goal is that both will prove safe for use in GWI patients

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 35 Years up to 70 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Veterans with Gulf War Illness * 35 to 70 years old * Good health by medical history prior to 1990 * Currently have no exclusionary diagnoses that could reasonably explain the symptoms of their fatiguing illness and their severity Exclusion Criteria: * Major depression with psychotic or melancholic features * Schizophrenia * Bipolar disorder * Delusional disorders * Dementias of any type * History or current alcohol abuse * History or current drug abuse * Current tobacco use * Organ failure * Defined rheumatologic * Inflammatory disorders * HIV * Hepatitis B and C * Primary sleep disorders * Steroids * Immunosuppressives

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