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
  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 Intervention Phase
Fibromyalgia
Drug: Active liquid remedy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


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

Estimated Enrollment: 60
Study Start Date: October 2000
Estimated Study Completion Date: September 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT00065702

Locations
United States, Arizona
U of Arizona College of Medicine, Program in Integrative Medicine
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
Investigators
Principal Investigator: Iris R. Bell, MD, PhD University of Arizona College of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00065702     History of Changes
Other Study ID Numbers: R21 AT000315-01, BellI
Study First Received: July 31, 2003
Last Updated: August 17, 2006
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
fibromyalgia
homeopathy
EEG
EKG
chronic pain

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014