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Biomarkers of Homeopathy in Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Active liquid remedy
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia, homeopathy, EEG, EKG, chronic pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • U of Arizona College of Medicine, Program in Integrative Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 31, 2003
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00065702
Brief Title
Biomarkers of Homeopathy in Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
fibromyalgia, homeopathy, EEG, EKG, chronic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Active liquid remedy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris R. Bell, MD, PhD
Organizational Affiliation
University of Arizona College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
U of Arizona College of Medicine, Program in Integrative Medicine
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States

12. IPD Sharing Statement

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Biomarkers of Homeopathy in Fibromyalgia

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