comparison of the effect of Saffron and Duloxetine on pain and depression in Rheumatoid arthritis

comparison of the effect of Saffron and Duloxetine on pain and depression in Rheumatoid arthritis

this is a double-blind clinical trial with placebo control.participants were selected from patients referring to the rheumatology clinic of imam Ali hospital in Zahedan who are treated with an RA diagnosis and have criteria for entering the study and if have the criteria of exit study removed from the list of volunteers. the sample size is 75 people who will be randomly assigned to 3 groups of 25 people.

groups will include the Duloxetine , saffron capsule and the placebo receptors.to reduce errors , the capsules of 3 groups are completely similar in appearance and the therapist and volunteer are not aware of its contents. at first , the volunteers undergo VAS test for pain and patient with a score over 40 will be included in the study. BPI and hamilton tests for depression are performed for all patients and the scores are recorded.

inclusion criteria: ACR criteria for RA pain intensity at least 40 according to VAS the age is equal to or greater than 18 years exclusion criteria: current or previous treatment with doluxetine axis I psychological disorder except MDD pain caused by traumatic injery other structural rheumatologic disorder except RA regional rheumatic diseases(osteoarthritis - bursitis - tendonitis) multiple sclerosis history of repeated surgery inflammatory , infectious , autoimmune arthritis serious medical illneses(untreated endocrine diseases - liver diseases - cardiovascular diseases - AIDS - seizure - malignancy) pregnancy - lactation - non proper use of contraception simultaneous use of psychiatric drugs(MAOIS , Serotonergic drugs) active suicidal thoughts abuse of alcohol or drugs over the past 2 years use of muscle relaxants , steroid , opioid analgesics , BZDs , anticonvulsants in a recent week injection of analgesic at painful point in a recent month use of thioridazine and other drugs affect on Cytochrome P450 in two recent weeks

the Duloxetine group will receive 30 mg capsules in the first week and then 60 mg will be given in two divided doses. the saffron group will be received 15 mg capsules daily in the first week and then twice daily. the placebo group will be received one capsule daily in the first week and then twice daily. for volunteers in the weeks 0,1,3 and 6 , BPI and Hamilton tests will be performed and their scores will be recorded and in addition to the tests , side effects and exclusion criteria will be reviewed. at intervals of weeks the tests CBC , LFT , FBS and electrolytes will be performed to monitor the side effects of the drugs. the duration of the drug in this study is considered to be 6 weeks. finally the variables considered are statistically tested and the result will be interpreted. groups will be identical in terms of age and gender.

reduce pain and depression in rheumatoid arthritis

easy to use and available from examples that are included the terms of entry, and assigning samples to either group is based on blocked grouping.

the sample size calculated for this study is 75 people that they will randomly be grouped into 25 people.groups will include the Duloxetine , saffron capsule and the placebo receptors.to reduce errors , the capsules of 3 groups are completely similar in appearance and the therapist and volunteer are not aware of its contents.