Viewing Study NCT00279942



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Study NCT ID: NCT00279942
Status: COMPLETED
Last Update Posted: 2012-01-06
First Post: 2006-01-18

Brief Title: Effect of Revival Soy on Fibromyalgia Pain
Sponsor: Mayo Clinic
Organization: Mayo Clinic

Study Overview

Official Title: Effect of Revival Soy on Fibromyalgia Pain
Status: COMPLETED
Status Verified Date: 2012-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: Fibromyalgia syndrome is a chronic generalized pain syndrome that affects the musculoskeletal system 1 This syndrome is typically diagnosed in patients who experience generalized musculoskeletal pain and have excessive tenderness in at least 11 of 18 specific points 2 Although the primary cause of fibromyalgia syndrome is unclear a growing body of evidence indicates that the widespread pain associated with this syndrome is due to abnormalities in the central nervous system Therefore drug therapy for fibromyalgia syndrome is most often aimed at the central nervous system and includes tricyclic antidepressants selective serotonin reuptake inhibitors dual serotonin and norepinephrine reuptake inhibitors analgesics and anticonvulsants 1

In addition to medical therapies complementary and alternative medicine therapies have been used to treat fibromyalgia syndrome symptoms 3 Soy is a widely used dietary supplement that has not been previously tested for treating fibromyalgia syndrome

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None