Determining the Effect of doxium Supplementation in Diabetic Retinopathy Determine the effect of doxium supplements on mild to severe diabetic retinopathy according to the thickness of the macula and vision
Design
Clinical trial with interventional and control group, community-based and pragmatic, with parallel groups, blinded two-way
Settings and conduct
Patients with type 2 diabetes with a minimum age of 18years are randomized by questioner in two groups by randomization software. Patients are divided into two groups. Patients in the target group receive doxium 50 mg per day and in placebo group, patients receive a placebo capsule for 6 months
Participants/Inclusion and exclusion criteria
Patients older than 18 years old, with mild to severe diabetic retinopathy
Exclusion: patients with other co-comorbidities, patients with a history of previous eye surgery, pregnancy, and lactation
Intervention groups
calcium dobisulate (doxium) capsules 500 mg,oraly , three times in one day for three months
Main outcome variables
Macular thickness
Ocular equity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220817055729N1
Registration date:2023-01-17, 1401/10/27
Registration timing:retrospective
Last update:2023-01-17, 1401/10/27
Update count:0
Registration date
2023-01-17, 1401/10/27
Registrant information
Name
Zahra Khodadadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3223 4897
Email address
zahra0khodadadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of doxium on vision and macular thickness in patients with mild to moderate diabetic retinopathy
Public title
doxium and retinopathy in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with non-proliferative diabetic retinopathy
Exclusion criteria:
other systemic disease except for diabetes
Other comorbid conditions such as CNV, RVO, Glaucoma etc.
Pregnancy
Lactation
The history of severe psychiatric illnesses such as schizophrenia, mood disorders, borderline disorders.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The samples of the participants in the study were randomly divided into two intervention and control groups using computer randomization software. The way of randomization in the groups will be that each patient is given a code and the codes are entered Microsoft Excel 2010 software and by executing the Randomization command and defining two groups, the software randomly places the codes in two separate groups. Then the output codes of the software will be placed in two groups 1 (intervention) and 2 (placebo).
Blinding (investigator's opinion)
Double blinded
Blinding description
Each eye was randomly assigned to receive one group of the medication. All preparations were individually prepared for each patient and patients and investigators were kept blinded to the randomized allocation and details of series of the medications throughout the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Urmia University of medical science Ethical comitte
Street address
Resalat St.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2022-01-02, 1400/10/12
Ethics committee reference number
IR.UMSU.HIMAM.REC.1400.014
Health conditions studied
1
Description of health condition studied
Diabetic retinopathy
ICD-10 code
H36
ICD-10 code description
Retinal disorders in diseases classified elsewhere
Primary outcomes
1
Description
macular thickness
Timepoint
before and 6 months of treatment
Method of measurement
Macular OCT (Optical Coherence Tomography)
2
Description
Visual Equity
Timepoint
before and 6 months of treatment
Method of measurement
Snellen chart
Secondary outcomes
empty
Intervention groups
1
Description
50 mg of oral capsule doxium (Om Pharma, Switzerland) once a days for 180 days (maximum duration of intervention is 180 days)
Category
Treatment - Drugs
2
Description
Control group: simulating placebo capsule for 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Imam Khomayni Hospital
Full name of responsible person
Ghader Motarjemizadeh
Street address
Ershad St.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3277 0397
Email
drmahyer@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Gholamhossein Farjah
Street address
Ershad St.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3278 0803
Email
Farjah.Gholamhossein@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Morteza Salimi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Ershad St.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 7331
Email
Morteza.salimi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Laya Hushmand
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Ershad St.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 7271
Email
Laya-hooshmand58@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Zahra Khodadadi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Ershad St.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3277 0397
Email
zahra0khodadadi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
The study aim will be described to all participants
When the data will become available and for how long
Hospital authorities for 1 year
To whom data/document is available
Hospital authorities
Under which criteria data/document could be used
Formal written permission form from the hospital
From where data/document is obtainable
Online via corresponding author email
What processes are involved for a request to access data/document
Taking formal permision form from hospital with hospital authorities signature should be sent to corresponding author