NCT00065702

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2000

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2003

Completed
Last Updated

August 18, 2006

Status Verified

August 1, 2006

First QC Date

July 31, 2003

Last Update Submit

August 17, 2006

Conditions

Fibromyalgia

Keywords

fibromyalgiahomeopathyEEGEKGchronic pain

Interventions

Active liquid remedyDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U of Arizona College of Medicine, Program in Integrative Medicine

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

FibromyalgiaChronic Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Iris R. Bell, MD, PhD

    University of Arizona College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

July 31, 2003

First Posted

August 1, 2003

Study Start

October 1, 2000

Study Completion

September 1, 2002

Last Updated

August 18, 2006

Record last verified: 2006-08

Locations

US(1)