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
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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):
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
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 |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013