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IRCT20171106037265N1 IRCT 2018-03-07 Zahedan University of Medical Sciences 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 2017-12-21 anticipated 75 Complete https://irct.ir/trial/27952 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Condition 1: Depression. Condition 2: Depression. Intervention 1: Intervention group: the Duloxetine group will receive 30 mg capsules(Sobhan pharmaceutical company) in the first week and then 60 mg will be given in two divided doses.the duration of the drug in this study is considered to be 6 weeks. Intervention 2: Control group:the placebo group will be received one capsule daily in the first week and then twice daily(construction of pharmacy under the contract of Zahedan university of medical sciences). the duration of the drug in this study is considered to be 6 weeks. Intervention 3: Intervention group: the saffron group will be received 15 mg capsules (Daroopakhsh pharmaceutical company) daily in the first week and then twice daily. the duration of the drug in this study is considered to be 6 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is no more information
public Akbar Fardi
Zahedan, DrHesabi square
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3329 5715 akbarfardi58@gmail.com Zahedan University of Medical Sciences scientific Akbar Fardi
Zahedan, DrHesabi square
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3329 5715 akbarfardi58@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) ACR criteria for RA pain intensity at least 40 according to VAS 18 years no limit Both current or previous treatment with duloxetin axis I psychological disorder except MDD other structural rheumatological disorder except RA inflammatory , infectious , autoimmune arthritis active suicidal thoughts F32.0 F32.1 Major depressive disorder, single episode, mild Major depressive disorder, single episode, moderate Treatment - Drugs Placebo Treatment - Drugs Intervention group: the Duloxetine group will receive 30 mg capsules(Sobhan pharmaceutical company) in the first week and then 60 mg will be given in two divided doses.the duration of the drug in this study is considered to be 6 weeks. Control group:the placebo group will be received one capsule daily in the first week and then twice daily(construction of pharmacy under the contract of Zahedan university of medical sciences). the duration of the drug in this study is considered to be 6 weeks. Intervention group: the saffron group will be received 15 mg capsules (Daroopakhsh pharmaceutical company) daily in the first week and then twice daily. the duration of the drug in this study is considered to be 6 weeks. Pain in Rheumatoid arthritis. Timepoint: first, third, sixth weeks. Method of measurement: BPI Questionnaire. Depression in Rheumatoid arthritis. Timepoint: first, third, sixth weeks. Method of measurement: Hamilton Depression Survey Questionnaire. Zahedan University of Medical Sciences Approved 2017-09-23 Ethics committe of Zahedan University of Medical Sciences DrHesabi Square zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)