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IRCT20120215009014N410 IRCT 2021-12-08 Hamedan University of Medical Sciences Comparison of the effect of Cichorium intybus and N-acetylcysteine versus placebo on the reduction of liver complications of Fingolimod in patients with multiple sclerosis Comparison of the effect of Cichorium intybus and N-acetylcysteine versus placebo on the reduction of liver complications of Fingolimod in patients with multiple sclerosis: a double-blind randomized clinical trial 2021-12-31 anticipated 63 Complete https://irct.ir/trial/60495 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare six sheets of paper, writing on two sheets the name of the intervention 1 and on two other sheets the name of the intervention 2 and on the third two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn. The six paper sheets will be then placed back into the container, and this action repeated until the sample size is reached, Blinding description: The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind. 3 Multiple sclerosis. Intervention 1: Intervention group 1:Tablet Fingolimod 0.5 mg once daily plus capsules containing Cichorium intybus extract 250 mg once daily for 4 months. Intervention 2: Intervention group 2:Tablet Fingolimod 0.5 mg once daily plus capsule containing N-acetylcysteine 1200 mg once daily for 4 months. Intervention 3: Control group:Tablet Fingolimod 0.5 mg once daily plus placebo capsule once daily for 4 months. 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 It depends on the situation and the results of the study as well as the approval of the financial supporting organization.
public Davood Sarmadi Khojasteh
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 skhdavid@yahoo.com Hamedan University of Medical Sciences scientific Dr. Sara Ataei
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 s.ataei@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Age 18 to 65 years; Multiple sclerosis; At least 3 weeks after receiving corticosteroids; 18 years 65 years Both Pregnancy and lactation; History of tuberculosis, AIDS, hepatitis, diabetes, kidney failure, or hypertension G35 Multiple sclerosis Treatment - Drugs Treatment - Drugs Placebo Intervention group 1:Tablet Fingolimod 0.5 mg once daily plus capsules containing Cichorium intybus extract 250 mg once daily for 4 months Intervention group 2:Tablet Fingolimod 0.5 mg once daily plus capsule containing N-acetylcysteine 1200 mg once daily for 4 months Control group:Tablet Fingolimod 0.5 mg once daily plus placebo capsule once daily for 4 months Serum levels of liver enzyme (ALT, AST, and bilirubin). Timepoint: 2 and 4 months after the intervention. Method of measurement: through laboratory test. Hamedan University of Medical Sciences Approved 2021-11-29 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)