Protocol summary
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Study aim
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The Purpose of this Study is to compare the Effectiveness of Ozone Therapy with Routine Medical Treatment in Patients with Multiple Sclerosis
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Design
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Parallel, single-blind, randomized clinical trial
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Settings and conduct
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66 Patients with MS that were referred to the manager's clinic of Kashan University of Medical Sciences, Kashan, Iran will be selected in the study. Patients will be divided into two groups. Patients of the control group will recieve medical treatment. Patients of the intervention group will recieve medical treatment and undergo ozone therapy. The changes of disease severity and serum levels of IL-33 will be determined and compared in patients at the beginning and at the end of the intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Age 20-60 years. Having Multiple Sclerosis(EDSS=0-4.5)
Exclusion Criteria: Having any local or systemic inflammation
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Intervention groups
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Control group: Receiving routine medical treatment(IFN-β )
Intervention group: Receiving routine medical treatment(IFN-β ) + ozone therapy
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Main outcome variables
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Disease severity; serum level of interleukin 33
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20171105037262N3
Registration date:
2018-03-14, 1396/12/23
Registration timing:
registered_while_recruiting
Last update:
2019-01-04, 1397/10/14
Update count:
1
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Registration date
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2018-03-14, 1396/12/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-03-11, 1396/12/20
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Expected recruitment end date
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2018-06-10, 1397/03/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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)
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Public title
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Ozone Therapy Effect on Multiple sclerosis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Having Multiple Sclerosis
EDSS=0-4.5
Exclusion criteria:
Unwillingness to continue cooperation
Any local or systemic inflammation
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Age
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From 20 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
66
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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".
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Since this is a single-blind study, our blindness would be single-blinded.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-02-12, 1396/11/23
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1396.111
Health conditions studied
1
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Description of health condition studied
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Multiple sclerosis
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ICD-10 code
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G35
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ICD-10 code description
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Multiple sclerosis
Primary outcomes
1
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Description
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Disease severity
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Timepoint
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At the beginning of the intervention
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Method of measurement
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Questionnaire
2
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Description
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IL-33
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Timepoint
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At the beginning of the intervention
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Method of measurement
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ELISA
Secondary outcomes
1
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Description
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Disease severity
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Timepoint
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At the end of the intervention
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Method of measurement
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EDSS
2
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Description
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IL-33
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Timepoint
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At the end of the intervention
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Method of measurement
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ELISA
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available