Saffron Vs duloxetine in the treatment of Fibromyalgia

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2016
INTERVENTION: Intervention 1: Intervention group 1: capsule Duloxetine 30 mg paer day in the first week and then 30 mg BID for 7 weeks. Intervention 2: Intervention group 2: capsule saffron 15 mg per day in the first week and then 15 mg BID for 7 weeks. Intervention group 1: capsule Duloxetine 30 mg paer day in the first week and then 30 mg BID for 7 weeks Intervention group 2: capsule saffron 15 mg per day in the first week and then 15 mg BID for 7 weeks Treatment ‐ Drugs CONDITION: Fibromyalgia Fibromyalgia. ; Fibromyalgia PRIMARY OUTCOME: 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). Severity of pain. Timepoint: Baseline and weeks: 2, 4, 6 and 8 after beginig of the treatment. Method of measurement: Breif Pain Index(BPI). INCLUSION CRITERIA: 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.
Epistemonikos ID: 3a692e21aaf5453d70df6ce49699bc0ee1604ea6
First added on: Mar 31, 2022