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IRCT20150628022956N7 IRCT 2019-07-02 Research Council of Hamedan University of Medical Sciences The effect of salimarin in patients with multiple sclerosis Study of the effect of Silimarin on the reduction of liver complications of fingolimod in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) 2019-05-21 anticipated 48 Complete https://irct.ir/trial/35513 interventional Randomization: Not randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: A sample of Fingolimod and Silymarin is packed in similar packaging and pass code. The researcher and the patient and the data collectors and those who evaluate the outcome do not know the contents of the pack and randomly give a patient an example. 2 Condition 1: Multiple Sclerosis. Condition 2: Liver disease. Intervention 1: Intervention group: Patients with multiple sclerosis(RRMS) receiving Fingolimod alone For 6 months. Intervention 2: Intervention group: Patients with multiple sclerosis(RRMS) receiving Fingolimod، With Silymarin with a dose of 140 mg once a day for 6 months. Yes - There is a plan to make this available What will be shared: The total potential data can be shared after unidentifiable people When: 1398 To whom: Researchers working in academia and academia Conditions: Use data with source Where to obtain: s.ataei@umsha.ac.ir How to obtain: Request via email Comments:
public Dr. Sara Ataei
Hamedan Boulevard, Shahid Fahmidah, Facing the People's Park of Hamedan University of Medical Sciences, Faculty of Pharmacy
Hamadan Iran (Islamic Republic of) 6581773946 +98 81 3838 1953 s.ataei@umsha.ac.ir Hamedan University of Medical Sciences scientific ِDr. Sara Ataei
In front of luna park, Hamedan
Hamadan Iran (Islamic Republic of) 6517838678 +98 81 3838 1953 s.ataei@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Patients who have had at least 3 weeks of onset of corticosteroid attack and received corticosteroids with liver enzymes following corticosteroid therapy. New Patients Receive Fingolimod Patients who are taking interferon and Glatiramer are advised to take the Fingolimod, provided they have no liver problem. Expanded Disability Status Scale below three. no limit no limit Both Pregnant and lactating women Patients who are allergic to Silymarin Patients with previous history of tuberculosis, HIV, hepatitis and liver problems. G35 K76 Multiple sclerosis Other diseases of liver Treatment - Drugs Treatment - Drugs Intervention group: Patients with multiple sclerosis(RRMS) receiving Fingolimod alone For 6 months Intervention group: Patients with multiple sclerosis(RRMS) receiving Fingolimod، With Silymarin with a dose of 140 mg once a day for 6 months Liver complications. Timepoint: At the beginning of the study (before the intervention) and 30, 60, 90, 120, 150 and 180 days after taking Silymarin. Method of measurement: Malondialdehyde index with Ohkawa method- Total antioxidant capacity index with FRAP method- Measurement of protein thiol groups with Ellman's Reagent (DTNB). Research Council of Hamedan University of Medical Sciences Approved 2019-03-02 Research Ethics Committee of the hamedan University of Medical Sciences Hamedan, Pazhoohesh Crossroad, In front of the Luna park, Hamedan University of Medical Sciences Hamedan Hamadan Iran (Islamic Republic of)