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Biomarkers of Homeopathy in Fibromyalgia - Article


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Clinical Trial: Biomarkers of Homeopathy in Fibromyalgia

This study has been completed.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)

Purpose

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.

Condition Treatment or Intervention Phase
Fibromyalgia
 Drug: Active liquid remedy
Phase I
Phase II

MedlinePlus related topics:  Fibromyalgia

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Further Study Details: 

Expected Total Enrollment:  60

Study start: October 2000;  Study completion: September 2002

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

Location Information


Arizona
      U of Arizona College of Medicine, Program in Integrative Medicine, Tucson,  Arizona,  85724,  United States

More Information

Study ID Numbers:  1R21AT00315-01; BellI
Record last reviewed:  July 2003
Last Updated:  October 13, 2004
Record first received:  July 31, 2003
ClinicalTrials.gov Identifier:  NCT00065702
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005


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Page Updated: June 1, 2005
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