Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Biomarkers of Homeopathy in Fibromyalgia

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00065702
First received: July 31, 2003
Last updated: August 17, 2006
Last verified: August 2006

July 31, 2003
August 17, 2006
October 2000
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00065702 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Biomarkers of Homeopathy in Fibromyalgia
Not Provided

The purpose of this study is to evaluate the efficacy of individualized classical homeopathy in treatment of persons with fibromyalgia and to determine the usefulness of electroencephalographic and electrocardiographic measures to serve as markers of differences between active and placebo treatment.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Fibromyalgia
Drug: Active liquid remedy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2002
Not Provided

Inclusion criteria:

  • ACR diagnosis of fibromyalgia;
  • Willing to take daily active or placebo liquid remedy under double blind conditions for 6 months, involving daily succussion and dilution of source liquid from a stock bottle;
  • Willingness/ability to comply with dietary and lifestyle restrictions, i.e., no coffee in any form, no comphor or menthol-containing products; no electric blankets, no strong aromatics, no routine vaccinations, no concomitant use of acupuncture, chiropractic, polarity therapy, psychic healing, or magnet therapy;
  • No dental drilling, MRI scans unless emergent;
  • Withhold food or drink 30 mins before/after therapy;
  • Stable conventional care for 2 months prior to entry;
  • Willing to undergo 3 diagnostic physical exams, and to permit videotaping of interview sessions;
  • Willing to fill out questionnaires

Exclusion criteria:

  • Steroid-dependent medical conditions;
  • Chronic benzodiazepine or anticonvulsant use;
  • Use of tricyclic antidepressants, antihypertensives, and other drugs that alter orthostasis;
  • Pregnancy;
  • History of seizure disorder or syncope;
  • Life-threatening medical conditions;
  • Current active asthma;
  • History of anaphylactic shock;
  • Insulin-dependent diabetes;
  • Active suicidal ideation or psychosis.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00065702
R21 AT000315-01, BellI
Not Provided
Not Provided
National Center for Complementary and Alternative Medicine (NCCAM)
Not Provided
Principal Investigator: Iris R. Bell, MD, PhD University of Arizona College of Medicine
National Center for Complementary and Alternative Medicine (NCCAM)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP