Biomarkers of Homeopathy in Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00065702
Recruitment Status : Completed
First Posted : August 1, 2003
Last Update Posted : August 18, 2006
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

July 31, 2003
August 1, 2003
August 18, 2006
October 2000
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Complete list of historical versions of study NCT00065702 on Archive Site
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Biomarkers of Homeopathy in Fibromyalgia
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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.
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Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Drug: Active liquid remedy
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2002
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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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
R21AT000315-01( U.S. NIH Grant/Contract )
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National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: Iris R. Bell, MD, PhD University of Arizona College of Medicine
National Center for Complementary and Integrative Health (NCCIH)
August 2006

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