Biomarkers of Homeopathy in Fibromyalgia

Fibromyalgia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00065702
• Other study ID #: R21AT000315-01
• Secondary ID: BellI
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 31, 2003
• Last updated: August 17, 2006
• Start date: October 2000
• Est. completion date: September 2002

Study information

• Verified date: August 2006
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Active liquid remedy

Locations

Country	Name	City	State
United States	U of Arizona College of Medicine, Program in Integrative Medicine	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States,