Fibromyalgia Clinical Trial
Official title:
Effect of Revival Soy on Fibromyalgia Pain
Verified date | January 2012 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Fibromyalgia is characterized by widespread pain that can lead to significant patient dysfunction and economic burden to society. The management of patients with fibromyalgia is difficult and no single treatment modality has been successful. We propose to study the effect of dietary soy supplement on quality of life associated with fibromyalgia.
Status | Completed |
Enrollment | 50 |
Est. completion date | September 2006 |
Est. primary completion date | August 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 76 Years |
Eligibility |
Inclusion Criteria: - Women and men age 18 - 76 - Able to understand and sign a consent form - Able to participate fully in all aspects of the study - Currently participating in Mayo Clinic's Fibromyalgia Treatment Program Exclusion Criteria: - Pregnant or lactating women - Allergy to soy or other study product ingredients - Diagnosis of bipolar disorder, schizophrenia or dementia - Diagnosis of diabetes mellitus or inflammatory bowel disease - Presently on soy product or use of soy within the last 30 days |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | Physicians Pharmaceuticals, Inc. |
United States,
Goldenberg DL, Burckhardt C, Crofford L. Management of fibromyalgia syndrome. JAMA. 2004 Nov 17;292(19):2388-95. Review. — View Citation
Holdcraft LC, Assefi N, Buchwald D. Complementary and alternative medicine in fibromyalgia and related syndromes. Best Pract Res Clin Rheumatol. 2003 Aug;17(4):667-83. Review. — View Citation
Wahner-Roedler DL, Thompson JM, Luedtke CA, King SM, Cha SS, Elkin PL, Bruce BK, Townsend CO, Bergeson JR, Eickhoff AL, Loehrer LL, Sood A, Bauer BA. Dietary soy supplement on fibromyalgia symptoms: a randomized, double-blind, placebo-controlled, early ph — View Citation
Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To gather preliminary data on whether dietary soy supplement can improve quality of life in patients with fibromyalgia as measured by the Fibromyalgia Impact Questionnaire (FIQ) and the Center for Epidemiologic Studies Depression Scale (CES-D). | 6 Weeks | No | |
Secondary | To assess the feasibility of recruiting 50 patients with fibromyalgia into a study of using a dietary supplement. | 3 Months | Yes |
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