Fibromyalgia Muscular Diseases
Conditions
Interventions
This is a randomized, double-blind, clinical trial with two arms: a treatment group and a placebo group. Each group will consist of 15 female patients, aged 18 to 60 years. The treatment group will re
Sponsors
Hospital das Clinicas da Faculdade de Medicina da Universidade De São Paulo
Hospital das Clinicas da Faculdade de Medicina da Universidade De São Paulo
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Thirty women diagnosed with fibromyalgia, aged 18 to 60 years, who meet the American College of Rheumatology criteria for the diagnosis of fibromyalgia will be recruited. Participants will be selected from the fibromyalgia outpatient clinic at the Rheumatology Service of the Hospital das Clínicas, School of Medicine, University of Sao Paulo, a high-complexity, tertiary service of the Unified Health System
Exclusion criteria
Exclusion criteria: Women with the following conditions will be excluded from the study: associated inflammatory rheumatic diseases; advanced chronic kidney disease (stages IV or V); diseases affecting locomotion and mobility, such as knee or hip osteoarthritis; severe psychiatric disorders that hinder proper understanding of the study and follow-up; pregnancy, use of oral anticoagulants (due to the risk of drug interactions); active neoplasia; and refusal to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It's expected to observe the effect of Bixa orellana L. phytocomplex supplementation (Chronic®) on fibromyalgia activity scores: Fibromyalgia Impact Questionnaire (FIQ) | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to observe the safety of Bixa orellana L. phytocomplex supplementation (Chronic®) in basic aspects of hepatotoxicity, renal function, and blood count;It is expected to observe the effect of Bixa orellana L. phytocomplex supplementation (Chronic®) on functional tests;It is expected to observe the effect of Bixa orellana L. phytocomplex supplementation (Chronic®) on fibromyalgia activity scores: Perceived Pain Scale (PDS);It is expected to observe the effect of Bixa orellana L. phytocomplex supplementation (Chronic®) on fibromyalgia activity scores: Visual Analog Scale (VAS) for pain and fatigue;It is expected to observe the effect of Bixa orellana L. phytocomplex supplementation (Chronic®) on fibromyalgia activity scores: Short Form-36 (SF-36);It is expected to observe the effect of Bixa orellana L. phytocomplex supplementation (Chronic®) on fibromyalgia activity scores: insomnia severity scale;It is expected to observe the effect of Bixa orellana L. phytocomplex supplementation (Chronic®) on fibromyalgia activity scores: fatigue severity scale | — |
Countries
BR
Contacts
Public ContactAndre Franco
Hospital das Clinicas da Faculdade de Medicina da Universidade De São Paulo
Outcome results
None listed