Comparison of ozone therapy and routine medical treatment efficacy on serum level changes of TNF-α and CRP as well as neurological improvement in recovery period in patients with ischemic stroke
Comparison of ozone therapy and routine medical treatment efficacy on serum level changes of TNF-α and CRP as well as neurological improvement in recovery period in patients with ischemic stroke
Design
Clinical trial with control group, with parallel and non-randomized groups
Settings and conduct
This study is an Inventional study and will be done in Ayatollah Yasrib hospital in Kashan in year 97 on 72 stroke patients referred to hospital emergency department.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Being in the phase of rehabilitation of ischemic stroke (NIHSS <15-mRs <5) and being alert to cooperate in the implementation of the plan
2- At least 2 months have passed since the onset of acute stroke
Exclusion criteria:
1. Hemorrhagic stroke
Cancer
3. Active infection
Intervention groups
Thirty-six patients in the first group (control group) will receive medication and receive physiotherapy, and 36 patients in the second group (intervention group) will benefit from ozone therapy in addition to the measures mentioned above.
Main outcome variables
TNF-α, recurrent stroke, CRP, disease severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200202046342N1
Registration date:2020-03-03, 1398/12/13
Registration timing:retrospective
Last update:2020-03-03, 1398/12/13
Update count:0
Registration date
2020-03-03, 1398/12/13
Registrant information
Name
Seyed Hadi hoseinipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5550 0111
Email address
hoseinipour-sh@mail.kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ozone therapy and routine medical treatment efficacy on serum level changes of TNF-α and CRP as well as neurological improvement in recovery period in patients with ischemic stroke
Public title
Ozone therapy and routine medical treatment efficacy on serum level changes of TNF-α and CRP as well as neurological improvement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being in the phase of ischemic stroke rehabilitation (NIHSS <15- mRs <5) and being alert to cooperate in the implementation of the plan
At least 2 months have passed since the onset of acute stroke
Exclusion criteria:
Hemorrhagic stroke
Cancer
Active infection
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan
Street address
Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8711111111
Approval date
2018-10-29, 1397/08/07
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.57
Health conditions studied
1
Description of health condition studied
Ischemic stroke
ICD-10 code
I63.9
ICD-10 code description
Transient cerebral ischemic attacks and related syndromes
Primary outcomes
1
Description
Serum levels of TNF-α and hs-CRP
Timepoint
Patients in the first group (control group) will receive the medication on the first day and will receive physiotherapy. After 90 days, serum levels of TNF-α and hs-CRP were also determined by ELISA.
Method of measurement
Serum TNF-α and hs-CRP levels were also determined by ELISA.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Receive normal medicine.Serum levels of TNF-α and hs-CRP will also be determined by ELISA with the US-based kit ELISA by eBioscience Iranian company Amines.
Category
Treatment - Drugs
2
Description
Intervention group: receive normal medical plus ozone therapy. Ozone therapy is performed in accordance with the standard protocol of major chemotherapy. Serum levels of TNF-α and hs-CRP will also be determined by ELISA with the US-based kit ELISA by eBioscience Iranian company Amines.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Yasrabi Hospital of Kashan
Full name of responsible person
hoseinipour seyed Hadi
Street address
Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8711111111
Phone
+98 31 5550 0111
Email
hoseinipour-sh@mail.kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
hoseinipour seyed Hadi
Street address
Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8711111111
Phone
+98 31 5550 0111
Email
hoseinipour-sh@mail.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
Kashan University of Medical Sciences
Full name of responsible person
Seyed Hadi Hoseinipour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8711111111
Phone
+98 31 5550 0111
Fax
Email
hoseinipour-sh@mail.kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mehdi Kheiran
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
General Practitioner
Street address
Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8711111111
Phone
+98 31 5550 0111
Email
hoseinipour-sh@mail.kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Seyed Hadi Hoseinipour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8711111111
Phone
+98 31 5550 0111
Fax
Email
hoseinipour-sh@mail.kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data can be shared.
When the data will become available and for how long
After printing the article
To whom data/document is available
researchers
Under which criteria data/document could be used
For more extensive study
From where data/document is obtainable
Email to responsible author
What processes are involved for a request to access data/document