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IRCT20120314009297N6 IRCT 2019-10-13 Mazandaran University of Medical Sciences The effect of tapering of prednisolone after pulse therapy in a MS attack Efficacy and safety evaluation of oral tapering prednisolone following inravenous methyl prednisolone to improve outcome of multiple sclerosis relapses: A randomized, double-blind, placebo-controlled trial 2019-06-30 anticipated 70 Complete https://irct.ir/trial/40311 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on the method of the permutation blocks of size 4, individuals are randomly divided into two groups. Samples will be divided into two experimental and control groups based on permutation blocks (blocks of size 4). It will be listed according to six possible ways (AABB, ABAB, ...) randomly and the arrangement of receiving intervention will be determined accordingly, Blinding description: Prednisolone and placebo tablets are completely similar in terms of color, size, smell and taste, produced by a completely similar manufacturing and packagings. Until the end of the study, no patient or researcher are aware of which drug each patient receives. Only one person who is not involved in sampling and data gathering is aware of the drug codes (medication or placebo). 3 Multiple sclerosis. Intervention 1: Intervention group: 1000 mg iv methylprednisolone for 5 days, followed by 50 mg oral prednisolone for 5 days, then 3/4 of prednisolone 50 mg for 5 days, then 1/2 prednisolone 50 mg for 5 days, then 1/4 mg prednisolone 50 mg for 5 days. Intervention 2: Control group: 1000mg of methylprednisolone for 5 days, followed by 50 mg of oral placebo for 5 days, then 3/4 mg of the drug for 5 days, then 1/2 of the placebo for 5 days, then 1/4 mg of the drug for 5 Day (a total of 20 days, the placebo dose is reduced and discontinued). No - There is not a plan to make this available Justification or reason for not sharing IPD is I have not decided yet - its release plan is still unclear
public Narjes Hendouei
20th Km Farahabad Road, Payambar Azam Academic Complex
Sari Iran (Islamic Republic of) 33971-48157 +98 11 3354 2472 hendoieen@yahoo.com Mazandaran University of Medical Sciences scientific Narjes Hendouei
20th Km Farahabad Road, Payambar Azam Academic Complex Sari
Sari Iran (Islamic Republic of) 33971-48157 +98 11 3354 2472 hendoieen@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Disability Status Scale (EDSS) 0 to 5.0 before the attack 18 years no limit Both Corticosteroid susceptibility Any worsening in symptoms that require a change in treatment Patient with optic neuritis Not complete Period of treatment by the patient A patient with active and bleeding stomach ulcer A patient with diabetes with uncontrolled blood sugar G35 Multiple sclerosis Treatment - Drugs Placebo Intervention group: 1000 mg iv methylprednisolone for 5 days, followed by 50 mg oral prednisolone for 5 days, then 3/4 of prednisolone 50 mg for 5 days, then 1/2 prednisolone 50 mg for 5 days, then 1/4 mg prednisolone 50 mg for 5 days Control group: 1000mg of methylprednisolone for 5 days, followed by 50 mg of oral placebo for 5 days, then 3/4 mg of the drug for 5 days, then 1/2 of the placebo for 5 days, then 1/4 mg of the drug for 5 Day (a total of 20 days, the placebo dose is reduced and discontinued) EDSS (Expanded Disability Status Scale)and FSS(Functional Systems Scores) assessments that sustained increase in EDSS is considered as a change in measure from the start of the study. These two measures ultimately assess the incapacity of the MS and the course of the disease after receiving treatment. Timepoint: The first month and the third month. Method of measurement: FSS, EDSS scale. Pulse methylprednisolone followed by oral prednisone Safety Assessment. Timepoint: The end of the first month. Method of measurement: Check list ARMS (assessment of relapse in multiple Sclerosis). Mazandaran University of Medical Sciences Approved 2019-06-17 Ethics committee of Mazandaran University of Medical Sciences Moallem Street, Moallem Square, Vice Chancellor For Research Sari Mazandaran Iran (Islamic Republic of)