Biomarkers of Homeopathy in Fibromyalgia - Tabular View

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Biomarkers of Homeopathy in Fibromyalgia

This study has been completed.
Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Biomarkers of Homeopathy in Fibromyalgia

Official Title ^†

Brief Summary

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.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Fibromyalgia

Intervention ^†

Drug: Active liquid remedy

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

October 2000

Completion Date

September 2002

Eligibility 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00065702

Organization ID

R21 AT000315-01

Secondary IDs ^††

BellI

Study Sponsor ^†

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^††

Investigators ^†

Principal Investigator:

Iris R. Bell, MD, PhD

University of Arizona College of Medicine

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

August 2006

First Received Date ^†

July 31, 2003

Last Updated Date

August 17, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.