Saffron Vs duloxetine in the treatment of Fibromyalgia
Phase 3
- Conditions
- Fibromyalgia.Fibromyalgia
- Registration Number
- IRCT201604261556N91
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
age at least 18 years old; meeting ACR criteria for Fibromyalgia; severity of pain at least 40 based on visual analogue scale.
Exclusion criteria: receiving Duloxetine at present or in the past; any psychiatric disorder except for MDD; osteoarthritis, multiple sclerosis; history of multiple surgeries, infectious disease, uncontrolled endocine disease, hepatic disease, cardiovascular disease, AIDS, epilepsy, malignancy; pregnancy; nursing women; receiving serotonergic agents or MAOIs; active suicidal thoughts; abuse of alcohol or substances in the previous two years; receiving anticonvulsants, muscle relaxants, opioids, steroids, benzodiazepines in the last week; receiving thioridazine.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of pain. Timepoint: Baseline and weeks: 2, 4, 6 and 8 after beginig of the treatment. Method of measurement: Breif Pain Index(BPI).;Severity of fatigue. Timepoint: Baseline and weeks: 2, 4, 6 and 8 after beginig of the treatment. Method of measurement: Global Fatigue Index.;Severity of fibromyalgia symptoms. Timepoint: Baseline and weeks: 2, 4, 6 and 8 after beginig of the treatment. Method of measurement: Fibromyalgia Impact Questionnaire(FIQ).
- Secondary Outcome Measures
Name Time Method