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IRCT20171105037262N3 IRCT 2018-03-14 Kashan University of Medical Sciences Ozone Therapy Effect on Multiple sclerosis Comparison of Ozone Therapy and Routine Medical Treatment Effect on Disease Severity and Serum Level Changes of IL-33 in Patients with Multiple Sclerosis (MS) 2018-03-11 anticipated 66 Complete https://irct.ir/trial/27913 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After specifying the sample size, the first four blocks of A and B letters are formed (6 blocks). Then, each of the blocks is numbered 1 to 6 and based on the selected numbers from random numbers table, we form a sequence of blocks, in which the letters A and B are located, and then randomly one of the letters are considered as the drug group and the other letter as the control group. This method is referred to as "Termuted Blocked Randomization", Blinding description: Since this is a single-blind study, our blindness would be single-blinded. 3 Multiple sclerosis. Intervention 1: Control group: Patients of this group will use interferon beta as a routine medical treatment for six months. EDSS will be assessed for each patient before and after treatment, and blood sample will be collected. Each blood sample will be sent to the laboratory to measure the serum levels of IL-33 by ELISA and with the MyBiosource product kit of the United States. Intervention 2: Intervention group: Patients in this group, in addition to interferon beta (routine medical treatment), based on the severity of disease, will undergo ozone therapy as major autohemotherapy with standard doses. EDSS will be assessed for each patient before and after treatment, and blood sample will be collected. Each blood sample will be sent to the laboratory to measure the serum levels of IL-33 by ELISA and with the MyBiosource product kit of the United States. 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 .
public Hassan Nikoueinejad
Ghotb-e-Ravandi Blvd
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5554 2999 hnikuinejad@yahoo.com Bagheiat-allah University of Medical Sciences scientific Hassan Nikoueinejad
Ghotb-e-Ravandi Blvd
Kashan Iran (Islamic Republic of) 8715988141 +98 21 8862 0791 hnikuinejad@yahoo.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Having Multiple Sclerosis EDSS=0-4.5 20 years 60 years Both Unwillingness to continue cooperation Any local or systemic inflammation G35 Multiple sclerosis Treatment - Drugs Treatment - Drugs Control group: Patients of this group will use interferon beta as a routine medical treatment for six months. EDSS will be assessed for each patient before and after treatment, and blood sample will be collected. Each blood sample will be sent to the laboratory to measure the serum levels of IL-33 by ELISA and with the MyBiosource product kit of the United States. Intervention group: Patients in this group, in addition to interferon beta (routine medical treatment), based on the severity of disease, will undergo ozone therapy as major autohemotherapy with standard doses. EDSS will be assessed for each patient before and after treatment, and blood sample will be collected. Each blood sample will be sent to the laboratory to measure the serum levels of IL-33 by ELISA and with the MyBiosource product kit of the United States. Disease severity. Timepoint: At the beginning of the intervention. Method of measurement: Questionnaire. IL-33. Timepoint: At the beginning of the intervention. Method of measurement: ELISA. Disease severity. Timepoint: At the end of the intervention. Method of measurement: EDSS. IL-33. Timepoint: At the end of the intervention. Method of measurement: ELISA. Kashan University of Medical Sciences Approved 2018-02-12 Ethics committee of Kashan University of Medical Science Ghotb-e-Ravandi Blvd Kashan Isfehan Iran (Islamic Republic of)