Biomarkers of Homeopathy in Fibromyalgia

NCT ID: NCT00065702

Last Updated: 2006-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Study Completion Date

2002-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Fibromyalgia

Keywords

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fibromyalgia homeopathy EEG EKG chronic pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Active liquid remedy

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Principal Investigators

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Iris R. Bell, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona College of Medicine

Locations

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U of Arizona College of Medicine, Program in Integrative Medicine

Tucson, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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BellI

Identifier Type: -

Identifier Source: secondary_id

R21AT000315-01

Identifier Type: NIH

Identifier Source: org_study_id

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