Trial record 9 of 9 for:    Ginkgo | NCCAM

Natural Antioxidants in the Treatment of Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00010842
First received: February 2, 2001
Last updated: August 17, 2006
Last verified: August 2006
  Purpose

The purpose of this study is to compare the effectiveness of three antioxidant regimens in treating the symptoms of multiple sclerosis (MS).


Condition Intervention Phase
Multiple Sclerosis
Drug: Ginkgo biloba
Drug: Alpha-lipoic acid
Drug: Vitamin E/Selenium
Drug: Essential fatty acids
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Natural Antioxidants in the Treatment of Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Study Start Date: September 1999
Estimated Study Completion Date: December 2004
Detailed Description:

Multiple sclerosis (MS) is an immune mediated disease of the central nervous system that affects over 350,000 Americans. T lymphocytes, macrophages and soluble mediators of inflammation cause demyelination and axonal injury in MS. Activated macrophages release nitric oxide and oxygen free radicals that cause demyelination and axonal injury in MS and experimental autoimmune encephalomyelitis (EAE). Natural antioxidants may favorably influence the course of MS by decreasing oxidative injury. Chronic relapsing EAE in mouse models is clinically and pathologically useful for testing potential therapies for MS.

This study will assess three natural antioxidant regimens for their potential as treatments for MS: Ginkgo biloba, alpha-lipoic acid/essential fatty acids, and vitamin E/selenium. The effects of each regimen will be compared to determine which regimen appears most effective at suppressing EAE and decreasing markers of oxidative injury in patients with MS. As part of this study, two smaller trials will be conducted. A Phase I/II trial in patients with MS will determine if the selected antioxidant regimen can decrease disease activity as detected with gadolinium-enhanced magnetic resonance imaging. The results of this study will serve as the basis for a Phase III trial to assess the long term effectiveness of natural antioxidant therapy in MS.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Exclusion Criteria:

  • Pregnant
  • Other significant health problems
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00010842

Locations
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97207
Sponsors and Collaborators
Investigators
Principal Investigator: Dr. Dennis Bourdette VA Medical Center-Brooklyn
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00010842     History of Changes
Obsolete Identifiers: NCT00009438
Other Study ID Numbers: P50 AT000066-01P1, P50 AT000066-01
Study First Received: February 2, 2001
Last Updated: August 17, 2006
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Antioxidants
Thioctic Acid
Selenium
Vitamin E
Vitamins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Micronutrients
Growth Substances
Trace Elements

ClinicalTrials.gov processed this record on August 20, 2014