Protocol summary
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Study aim
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The aim of this study was to investigate the role of coenzyme Q10 in improve of Inflammatory and oxidative status and beta-secretase level in diabetic retinopathy patients.
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Design
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At the beginning of the study cognition status as well as serum beta-secretase levels and inflammatory and oxidant and antioxidant status of patients are evaluated. Treatment for three month in two groups:1) oral coenzyme Q10,200 mg daily and 2)Placebo will be done. At the end, the mentioned factors will be measured again and possible changes will be analyzed based on statistical calculations.
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Settings and conduct
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Cognitive status will be assessed using standard questionnaires. serum Beta-secretase levels and oxidation status will be determined by the relevant kits according to approved protocols. The study will be performed at Taban eye clinic in Qom Province.
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Participants/Inclusion and exclusion criteria
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Age between 40 and 75 years
Blood pressure and glucose under control
Adequate level of awareness and cognition
exclude :
neurological disease such as Alzheimer's, Parkinson's, cognitive impairment and MS.
irreversible other eye disease such as glaucoma, cataracts, etc.
Consumption of other antioxidant drugs such as vitamins E, C and A, etc.
Taking immunosuppressive drugs for the past two months
Patients with uncontrolled diabetes and Hypertension
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Intervention groups
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1)Coenzyme Q10 ,n=32
2)Placebo ,n=32
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Main outcome variables
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Inflammatory and oxidant factors and beta secretase activity levels of serum
General information
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Reason for update
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change in proposal For operational and feasibility reasons
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160524028046N2
Registration date:
2022-03-18, 1400/12/27
Registration timing:
prospective
Last update:
2025-05-12, 1404/02/22
Update count:
2
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Registration date
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2022-03-18, 1400/12/27
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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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2023-04-04, 1402/01/15
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Expected recruitment end date
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2026-03-06, 1404/12/15
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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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Evaluation the effect of coenzyme Q10 and placebo on blood inflammatory and oxidant factors and beta-secretase activity levels in diabetic retinopathy patients
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Public title
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Evaluation the effect of coenzyme Q10 on blood inflammatory and oxidant factors and beta-secretase activity levels in diabetic retinopathy patients
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Purpose
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Health service research
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Inclusion/Exclusion criteria
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Inclusion criteria:
diabetic retinopathy patients
Exclusion criteria:
Other effective ocular disease and neurological diseases such as Alzheimer's and MS
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Age
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From 40 years old to 75 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
64
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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According to the method of random allocation rule, 32 balls called treatment group and 32 balls called placebo are mixed with each other and randomly removed one by one. The removed ball will not be replaced.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The study will be duble blinded. Patients will be blinded to the type of intervention and the researcher who must evaluate and record the data will be blinded to the type of intervention.
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Placebo
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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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2022-03-06, 1400/12/15
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Ethics committee reference number
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IR.UMSHA.REC.1400.969
Health conditions studied
1
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Description of health condition studied
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Diabetic Retinopathy
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ICD-10 code
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E08.31
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ICD-10 code description
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Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy
Primary outcomes
1
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Description
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Inflammatory/Anti Inflammatory factors
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Timepoint
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pre and post Treatment
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Method of measurement
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Elisa Kits
2
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Description
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Oxidant /Anti Oxidant Factors
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Timepoint
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pre and post Treatment
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Method of measurement
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Elisa kits
3
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Description
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serum Beta secretase activity
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Timepoint
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pre and post Treatment
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Method of measurement
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Elisa Kit
Secondary outcomes
1
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Description
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Blood pressure
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Timepoint
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pre and post Treatment
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Method of measurement
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Standard Barometer
Intervention groups
1
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Description
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Intervention group:Patients will be treated with Coenzyme Q10 soft gel prepared from jalinus Pharmaceutical Company (Tehran-Iran),orally (200mg), daily for 120 days
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo
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Category
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Placebo
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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Hamedan 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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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available