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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Protocol summary
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 and IL-37 will determine and compare in patients at the beginning and at the end of the intervention.
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.
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 and IL-37 will determinebe determined and comparecompared in patients at the beginning and at the end of the intervention.
66 بیمار مبتلا به MS واجد شرایط و ارجاع شده به کلینیک مجری طرح وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. بیماران به دوگروه تقسیم خواهند شد. به طوری که بیماران گروه آزمایش ازن تراپی و آنتی هیستامین و درمان مدیکال و گروه کنترل فقط درمان مدیکال(اینترفرون بتا) دریافت خواهند کرد. تغییرات شدت بیماری و سطح سرمی اینترلوکین های 33 و 37 در ابتدا و انتهای مداخله در بیماران تعیین و مقایسه خواهد شد.
66 بیمار مبتلا به MS واجد شرایط و ارجاع شده به کلینیک مجری طرح وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. بیماران به دوگروه تقسیم خواهند شد. به طوری که بیماران گروه آزمایش ازن تراپی و آنتی هیستامین و درمان مدیکال و گروه کنترل فقط درمان مدیکال(اینترفرون بتا) دریافت خواهند کرد. تغییرات شدت بیماری و سطح سرمی اینترلوکین 33 در ابتدا و انتهای مداخله در بیماران تعیین و مقایسه خواهد شد.
66 بیمار مبتلا به MS واجد شرایط و ارجاع شده به کلینیک مجری طرح وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. بیماران به دوگروه تقسیم خواهند شد. به طوری که بیماران گروه آزمایش ازن تراپی و آنتی هیستامین و درمان مدیکال و گروه کنترل فقط درمان مدیکال(اینترفرون بتا) دریافت خواهند کرد. تغییرات شدت بیماری و سطح سرمی اینترلوکین های 33 و 37 در ابتدا و انتهای مداخله در بیماران تعیین و مقایسه خواهد شد.
Inclusion Criteria: Age 20-60 years. Having Multiple Sclerosis(EDSS=0-5)
Exclusion Criteria: Having any local or systemic inflammation
Inclusion Criteria: Age 20-60 years. Having Multiple Sclerosis(EDSS=0-4.5)
Exclusion Criteria: Having any local or systemic inflammation
Inclusion Criteria: Age 20-60 years. Having Multiple Sclerosis(EDSS=0-54.5) Exclusion Criteria: Having any local or systemic inflammation
شرايط ورود سن 20 الي 60 سال و داشتن بيماري مولتيپل اسكلروزيس و EDSS=0-5 مي باشد.
شرايط خروج داشتن هرگونه التهاب لوکال یا سیستمیک است
شرايط ورود سن 20 الي 60 سال و داشتن بيماري مولتيپل اسكلروزيس و EDSS=0-4.5 مي باشد.
شرايط خروج داشتن هرگونه التهاب لوکال یا سیستمیک است
شرايط ورود سن 20 الي 60 سال و داشتن بيماري مولتيپل اسكلروزيس و EDSS=0-54.5 مي باشد. شرايط خروج داشتن هرگونه التهاب لوکال یا سیستمیک است
Disease severity; serum level of interleukin 33 and 37
Disease severity; serum level of interleukin 33
Disease severity; serum level of interleukin 33 and 37
شدت بیماری؛ سطح سرمی اینترلوکین 33 و 37
شدت بیماری؛ سطح سرمی اینترلوکین 33
شدت بیماری؛ سطح سرمی اینترلوکین 33 و 37
General information
Comparison of Ozone Therapy and Routine Medical Treatment Effect on Disease Severity and Serum Level Changes of IL-33 and 37 in Patients with Multiple Sclerosis (MS)
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)
Comparison of Ozone Therapy and Routine Medical Treatment Effect on Disease Severity and Serum Level Changes of IL-33 and 37 in Patients with Multiple Sclerosis (MS)
مقایسه ی اثر ازن تراپی و درمان مدیکال معمول بر شدت بیماری و تغییرات سطح سرمی اینترلوکین های 33 و 37 بیماران مبتلا به مولتیپل اسکلروزیس(MS)
مقایسه ی اثر ازن تراپی و درمان مدیکال معمول بر شدت بیماری و تغییرات سطح سرمی اینترلوکین 33 بیماران مبتلا به مولتیپل اسکلروزیس(MS)
مقایسه ی اثر ازن تراپی و درمان مدیکال معمول بر شدت بیماری و تغییرات سطح سرمی اینترلوکین های 33 و 37 بیماران مبتلا به مولتیپل اسکلروزیس(MS)
Having Multiple Sclerosis
EDSS=0-5
Having Multiple Sclerosis
EDSS=0-4.5
Having Multiple Sclerosis EDSS=0-54.5
داشتن بيماري مولتيپل اسكلروزيس
EDSS=0-5
داشتن بيماري مولتيپل اسكلروزيس
EDSS=0-4.5
داشتن بيماري مولتيپل اسكلروزيس EDSS=0-54.5
Primary outcomes
#1
IL-37
empty
IL-37
اینترلوکین 37
empty
اینترلوکین 37
At the beginning of the intervention
empty
At the beginning of the intervention
ابتدای مداخله
empty
ابتدای مداخله
ELISA
empty
ELISA
الایزا
empty
الایزا
Secondary outcomes
#1
IL-37
empty
IL-37
اینترلوکین 37
empty
اینترلوکین 37
At the end of the intervention
empty
At the end of the intervention
انتهای مداخله
empty
انتهای مداخله
ELISA
empty
ELISA
الایزا
empty
الایزا
Intervention groups
#1
Control group: Patients of this group will use interferon beta as a routine medical treatment for
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.
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.
گروه کنترل: بیماران این گروه به مدت شش ماه از اینترفرون بتا به عنوان داروی مدیکال معمول استفاده می کنند. از هر بیمار قبل و بعد از درمان، EDSS گرفته شده و خونگیری نیز بعمل می آید. هر نمونه خون به آزمایشگاه فرستاده خواهد شد تا سطح سرمی سیتوکین های IL-33 و IL-37 به روش الایزا و با کیت MyBiosource محصول آمریکا اندازه گیری شود.
گروه کنترل: بیماران این گروه به مدت شش ماه از اینترفرون بتا به عنوان داروی مدیکال معمول استفاده می کنند. از هر بیمار قبل و بعد از درمان، EDSS گرفته شده و خونگیری نیز بعمل می آید. هر نمونه خون به آزمایشگاه فرستاده خواهد شد تا سطح سرمی سیتوکین IL-33 به روش الایزا و با کیت MyBiosource محصول آمریکا اندازه گیری شود.
گروه کنترل: بیماران این گروه به مدت شش ماه از اینترفرون بتا به عنوان داروی مدیکال معمول استفاده می کنند. از هر بیمار قبل و بعد از درمان، EDSS گرفته شده و خونگیری نیز بعمل می آید. هر نمونه خون به آزمایشگاه فرستاده خواهد شد تا سطح سرمی سیتوکین های IL-33 و IL-37 به روش الایزا و با کیت MyBiosource محصول آمریکا اندازه گیری شود.
#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 taken blood sample from them. Each blood sample will be sent to the laboratory to measure the serum levels of IL-33 and IL-37 cytokines 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.
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 taken blood sample from themwill be collected. Each blood sample will be sent to the laboratory to measure the serum levels of IL-33 and IL-37 cytokines by ELISA and with the MyBiosource product kit of the United States.
گروه مداخله: بیماران این گروه علاوه بر اینترفرون بتا( داروی مدیکال معمول)بر اساس شدت بیماری، تحت ازن تراپی با دوز های استاندارد و به صورت هموتراپی ماژور قرار می گیرند.از هر بیمار قبل و بعد از درمان، EDSS گرفته شده و خونگیری نیز بعمل می آید. هر نمونه خون به آزمایشگاه فرستاده خواهد شد تا سطح سرمی سیتوکین های IL-33 و IL-37 به روش الایزا و با کیت MyBiosource محصول آمریکا اندازه گیری شود.
گروه مداخله: بیماران این گروه علاوه بر اینترفرون بتا( داروی مدیکال معمول)بر اساس شدت بیماری، تحت ازن تراپی با دوز های استاندارد و به صورت هموتراپی ماژور قرار می گیرند.از هر بیمار قبل و بعد از درمان، EDSS گرفته شده و خونگیری نیز بعمل می آید. هر نمونه خون به آزمایشگاه فرستاده خواهد شد تا سطح سرمی سیتوکین IL-33 به روش الایزا و با کیت MyBiosource محصول آمریکا اندازه گیری شود.
گروه مداخله: بیماران این گروه علاوه بر اینترفرون بتا( داروی مدیکال معمول)بر اساس شدت بیماری، تحت ازن تراپی با دوز های استاندارد و به صورت هموتراپی ماژور قرار می گیرند.از هر بیمار قبل و بعد از درمان، EDSS گرفته شده و خونگیری نیز بعمل می آید. هر نمونه خون به آزمایشگاه فرستاده خواهد شد تا سطح سرمی سیتوکین های IL-33 و IL-37 به روش الایزا و با کیت MyBiosource محصول آمریکا اندازه گیری شود.
Recruitment centers
#1
Name of recruitment center - English: Shahid Beheshti hospital
Name of recruitment center - Persian: بیمارستان شهید بهشتی
Full name of responsible person - English: Ebrahim Kouchaki
Full name of responsible person - Persian: ابراهیم کوچکی
Street address - English: بلوار قطب راوندي
Street address - Persian: Ghotb-e-Ravandi Blvd
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715988141
Phone: +98 31 5554 2999
Fax:
Email: koochaki@kaums.ac.ir
Web page address:
Name of recruitment center - English: Shahid Beheshti hospital
Name of recruitment center - Persian: بیمارستان شهید بهشتی
Full name of responsible person - English: Ebrahim Kouchaki
Full name of responsible person - Persian: ابراهیم کوچکی
Street address - English: Ghotb-e-Ravandi Blvd
Street address - Persian: بلوار قطب راوندي
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715988141
Phone: +98 31 5554 2999
Fax:
Email: koochaki@kaums.ac.ir
Web page address:
Name of recruitment center - English: Shahid Beheshti hospital Name of recruitment center - Persian: بیمارستان شهید بهشتی Full name of responsible person - English: Ebrahim Kouchaki Full name of responsible person - Persian: ابراهیم کوچکی Street address - English: بلوار قطب راونديGhotb-e-Ravandi Blvd Street address - Persian: Ghotb-e-Ravandi Blvdبلوار قطب راوندي City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8715988141 Phone: +98 31 5554 2999 Fax: Email: koochaki@kaums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Gholamali Hamidi
Full name of responsible person - Persian: غلامعلی حمیدی
Street address - English: Ghotb-e-Ravandi Blvd, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715988141
Phone: +98 31 5554 2999
Fax:
Email: research@kaums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hamidreza Banafsheh
Full name of responsible person - Persian: حمیدرضا بنفشه
Street address - English: Ghotb-e-Ravandi Blvd, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715988141
Phone: +98 31 5554 2999
Fax:
Email: research@kaums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Gholamali HamidiHamidreza Banafsheh Full name of responsible person - Persian: غلامعلی حمیدیحمیدرضا بنفشه Street address - English: Ghotb-e-Ravandi Blvd, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8715988141 Phone: +98 31 5554 2999 Fax: Email: research@kaums.ac.ir Web page address:
Sharing plan
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empty
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Protocol summary
Study aim
The Purpose of this Study is to compare the Effectiveness of Ozone Therapy with Routine Medical Treatment in Patients with Multiple Sclerosis
Design
Parallel, single-blind, randomized clinical trial
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age 20-60 years. Having Multiple Sclerosis(EDSS=0-4.5)
Exclusion Criteria: Having any local or systemic inflammation
Intervention groups
Control group: Receiving routine medical treatment(IFN-β )
Intervention group: Receiving routine medical treatment(IFN-β ) + ozone therapy
Main outcome variables
Disease severity; serum level of interleukin 33
General information
Reason for update
Acronym
IRCT registration information
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
Registration date
2018-03-14, 1396/12/23
Registrant information
Name
mohammadhossein pourhanifeh
Name of organization / entity
kashan university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 31 5558 0988
Email address
pourhanifeh-mh@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-11, 1396/12/20
Expected recruitment end date
2018-06-10, 1397/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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)
Public title
Ozone Therapy Effect on Multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having Multiple Sclerosis
EDSS=0-4.5
Exclusion criteria:
Unwillingness to continue cooperation
Any local or systemic inflammation
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
Blinding description
Since this is a single-blind study, our blindness would be single-blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Science
Street address
Ghotb-e-Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2018-02-12, 1396/11/23
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1396.111
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Disease severity
Timepoint
At the beginning of the intervention
Method of measurement
Questionnaire
2
Description
IL-33
Timepoint
At the beginning of the intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
Disease severity
Timepoint
At the end of the intervention
Method of measurement
EDSS
2
Description
IL-33
Timepoint
At the end of the intervention
Method of measurement
ELISA
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Ebrahim Kouchaki
Street address
Ghotb-e-Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
koochaki@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidreza Banafsheh
Street address
Ghotb-e-Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hassan Nikoueinejad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Immunology
Street address
Ghotb-e-Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
hnikuinejad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hassan Nikoueinejad
Position
Assosiate Professor
Latest degree
Specialist
Other areas of specialty/work
Immunology
Street address
Ghotb-e-Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 21 8862 0791
Email
hnikuinejad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammadhossein Pourhanifeh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Ghotb-e-Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 0988
Email
mhph.lord.1996@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available