Evaluating the effectiveness of Ozone therapy in improving Visual Evoked Potentials (VEP) parameters in diabetic patients
Design
A pragmatic, single-centre, parallel-group, nonblinded, phase 2 randomised controlled trial which will be conducted on 60 DM patients and the patients will be followed up for 3 months.
Settings and conduct
Diabetic patients who visit Baqiyatallah clinic will be randomly allocated into two groups. After obtaining written informed consent for the oxygen-ozone therapy, patients of the treatment group will undergo ozone therapy ( Major and Minor Autohemotherapy ) twice weekly for 20 sessions in addition to standard conventional treatments. Patients of the control group will just undergo standard conventional treatments. VEP will be recorded in all patients at baseline and monthly thereafter for 3 months. HbA1C levels are measured before and after the intervention in all patients.
Participants/Inclusion and exclusion criteria
Patients who have been diagnosed with Diabetes Mellitus (DM) will be recruited unless having hypersensitivity to ozone or having abnormal coagulation or thyroid function tests
Intervention groups
Patients of the treatment group will undergo a cycle of systemic oxygen-ozone therapy in addition to the standard conventional therapy such as metabolic control. Patients of the control group will not receive any treatments other than the standard conventional therapy.
Main outcome variables
HbA1C (Pre-treatment and Post-treatment); P100 wave latency and amplitude (at baseline and monthly thereafter until 3 months)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191125045492N1
Registration date:2019-11-27, 1398/09/06
Registration timing:prospective
Last update:2019-11-27, 1398/09/06
Update count:0
Registration date
2019-11-27, 1398/09/06
Registrant information
Name
Ali Sarrafzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3324 7683
Email address
ali_sarrafzadeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-20, 1398/09/29
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Ozone therapy with conventional therapy in improving visual evoked potentials parameters in diabetic patients
Public title
Comparison of the effectiveness of Ozone therapy with conventional therapy in the improvement of visual pathways function in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have been diagnosed with Diabetes Mellitus
Exclusion criteria:
Patients with hypersensitivity to ozone
Patients with abnormal thyroid function tests
Patients with abnormal coagulation tests
Patients with G6PD deficiency
Pregnant or lactating women
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the individuals will be randomly allocated into two groups (Treatment and Control) by using the block randomization method. The procedure of randomization will be carried out by using the SPSS software and the block size will be 4. Allocation concealment will be carried out.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
No. 2, South Sheikh Bahaei Ave.
City
Tehran
Province
Tehran
Postal code
1435912345
Approval date
2019-05-21, 1398/02/31
Ethics committee reference number
IR.BMSU.REC.1398.043
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
VEP P100 wave amplitude
Timepoint
before intervention and 1, 2, 3 months after the start of intervention
Method of measurement
VEP measurement using visual electrophysiology device
2
Description
VEP P100 wave latency
Timepoint
before intervention and 1, 2, 3 months after the start of intervention
Method of measurement
VEP measurement using visual electrophysiology device
Secondary outcomes
1
Description
Hemoglobin A1C
Timepoint
3 months after the start of intervention
Method of measurement
lab kit
Intervention groups
1
Description
Intervention group:
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ozonetherapy Research Center, Baqiyatallah University of Medical Sciences
Full name of responsible person
Morteza Izadi
Street address
No. 2, South Sheikh Bahaei Ave.
City
Tehran
Province
Tehran
Postal code
1435912345
Phone
+98 21 8804 6515
Email
ali_sarrafzadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr. Gholamhosein Alishiri
Street address
Vanak Square, Mullasadra Street, South Sheikh Bahaei Ave.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5250
Email
R.bmsu@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Ali Sarrafzadeh
Position
General Practitioner on military service
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 21, Ahmadzade Ave., Ansari Blvd.
City
Rasht
Province
Guilan
Postal code
4153786864
Phone
+98 13 3324 7683
Fax
Email
ali_sarrafzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ali Sarrafzadeh
Position
General Practitioner on military service
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 21, Ahmadzade Ave., Ansari Blvd.
City
Rasht
Province
Guilan
Postal code
4153786864
Phone
+98 13 3324 7683
Fax
Email
ali_sarrafzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ali Sarrafzadeh
Position
General Practitioner on military service
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 21, Ahmadzade Ave., Ansari Blvd.
City
Rasht
Province
Guilan
Postal code
4153786864
Phone
+98 13 3324 7683
Fax
Email
ali_sarrafzadeh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available