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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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History
# Registration date Revision Id
3 2025-05-08, 1404/02/18 339579
2 2025-04-22, 1404/02/02 339080
1 2022-03-18, 1400/12/27 220387
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  • Protocol summary

    The aim of this study was to investigate the role of coenzyme Q10 in the treatment of visual disorders, especially visual field defects and cognitive impairments due to stroke and its effect on serum beta-secretase levels and oxidative balance .
    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.
    هدف از مطالعه حاضر بررسی نقش کوانزیم کیوتن در درمان اختلالات بینایی خصوصاً نقص میدان بینایی و اختلال در توانایی های شناختی ناشی از استروک و تأثیر آن بر سطوح بتاسکرتاز سرم و توازن اکسیدانی بیماران است
    هدف از مطالعه حاضر بررسی نقش کوانزیم کیوتن در بهبود وضعیت التهابی و استرس اکسیداتیو و تأثیر آن بر سطح فعالیت بتاسکرتاز بیماران است.
    At the beginning of the study, visual field, visual acuity and Contrast sensitivity,cognition status as well as serum beta-secretase levels and oxidant and antioxidant status of patients are evaluated. Treatment for one month in two groups:1) oral coenzyme Q10,10mg/kg 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.
    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.
    در ابتدای مطالعه میدان بینایی،حدت بینایی و کنتراست سنسیتیویتی ،وضعیت شناختی و نیز سطوح بتاسکرتاز و وضعیت اکسیدانی و آنتی اکسیدانی سرمی بیماران ارزیابی میشود.درمان به مدت یکماه در دو گروه ۱)کوانزیم کیوتن به میزان ۱۰ میلی گرم به ازای هرکیلوگرم وزن بصورت خوراکی و ۲)پلاسبو انجام خواهد شد. در پایان فاکتور های ذکر شده مجددا اندازه گیری شده و تغییرات احتمالی براساس محاسبات آماری تحلیل خواهد شد.
    در ابتدای مطالعه وضعیت شناختی و نیز سطوح بتاسکرتاز و وضعیت اکسیدانی و آنتی اکسیدانی و التهابی سرمی بیماران ارزیابی میشود.درمان به مدت سه ماه در دو گروه ۱)کوانزیم کیوتن به میزان ۲۰۰ میلیگرم روزانه بصورت خوراکی و ۲)پلاسبو انجام خواهد شد. در پایان فاکتور های ذکر شده مجددا اندازه گیری شده و تغییرات احتمالی براساس محاسبات آماری تحلیل خواهد شد.
    The visual field will be performed by the "Rare Bit" perimetry. Visual acuity and contrast sensitivity assessments will be used by Snelln chart and Freiburg contrast test, respectively. 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 Shahid Beheshti Hospital of Qom University of Medical Sciences
    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.
    میدان بینایی ب روش پریمتری "رار بیت" انجام خواهد شد.برای ارزیابی حدت بینایی و کنتراست سنسیتیویتی به ترتیب از اسنلن چارت و تست کنتراست فرایبورگ استفاده خواهد شد.,وضعیت شناختی با استفاده از پرسشنامه های استاندارد بررسی خواهد شد.سطوح بتاسکرتاز و وضعیت اکسیدانی سرم توسط کیت های مربوطه و طبق پروتوکل های تایید شده مشخص خواهند شد.مطالعه در بیمارستان شهید بهشتی دانشگاه علوم پزشکی قم انجام خواهد شد.
    ,وضعیت شناختی با استفاده از پرسشنامه های استاندارد بررسی خواهد شد.سطوح بتاسکرتاز و وضعیت اکسیدانی التهابی سرم توسط کیت های مربوطه و طبق پروتوکل های تایید شده مشخص خواهند شد.مطالعه در کلینیک چشم پزشکی تابان قم انجام خواهد شد.
    Age between 18 and 80 years maximum of one week has passed since the onset of stroke Has visual field defect Adequate level of awareness and cognition for performing tests and questionnaires. exclud: previous history of stroke pre-stroke neurological disease such as Alzheimer's, Parkinson's, cognitive impairment and MS. irreversible eye disease that can cause visual field defects 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
    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
    سن بین 18 تا 80 سال حداکثر یک هفته از شروع علائم استروک گذشته باشد دارای علائم نقص میدان بینایی سطح هوشیاری و شناختی مناسب جهت انجام تست‌ها و پرسشنامه‌ها عدم ورود: هرگونه سابقه استروک قبلی هرگونه بیماری نورولوژیک قبل از ابتلا به سکته از قبیل آلزایمر، پارکینسون، اختلال شناخت و ام اس. هرگونه بیماری چشمی غیرقابل اصلاح که می‌تواند نقص میدان بینایی ایجاد کند از قبیل گلوکوم و کاتاراکت و... مصرف سایر داروهای آنتی‌اکسیدانی مانند ویتامین ای و سی و آ و.. مصرف داروهای سرکوبگر ایمنی طی دو ماه گذشته بیماران دچار دیابت و فشار خون کنترل نشده
    سن بین 40تا 75سال فشار و گلوکز خون کنترل شده سطح هوشیاری و شناختی مناسب . عدم ورود: هرگونه بیماری نورولوژیک قبل از ابتلا به سکته از قبیل آلزایمر، پارکینسون، اختلال شناخت و ام اس. هرگونه بیماری چشمی غیرقابل اصلاح از قبیل گلوکوم و کاتاراکت و... مصرف سایر داروهای آنتی‌اکسیدانی مانند ویتامین ای و سی و آ و.. مصرف داروهای سرکوبگر ایمنی طی دو ماه گذشته
    visual field
    Inflammatory and oxidant factors and beta secretase activity levels of serum
    میدان بینایی
    شاخص های التهابی و اکسیدانی و سطح فعالیت بتاسکرتاز سرمی

  • General information

    18
    40
    80
    75
    3
    2-3
    2022-04-04, 1401/01/15
    2023-04-04, 1402/01/15
    2023-03-06, 1401/12/15
    2026-03-06, 1404/12/15
    empty
    change in proposal For operational and feasibility reasons
    empty
    تغییر پروپوزال به دلایل امکان انجام طرح از جمله اولویت درمان های دیگر بیماران و تغییر شهر محل خدمت برخی همکاران طرح
    Evaluation of the effect of Coenzyme Q10 on visual field,cognition abilities and serum levels of Beta secretase and oxidative factors in acute ischemic stroke patients with visual field defects
    Evaluation the effect of coenzyme Q10 on blood inflammatory and oxidant factors and beta-secretase activity levels in diabetic retinopathy patients
    بررسی اثر کوانزیم Q10 بر میدان بینایی، توانایی‌های شناختی، سطوح بتا سکرتاز و شاخص‌های اکسیداتیو سرمی بیماران استروک ایسکمیک حاد دچار نقص میدان بینایی
    بررسی اثر کوانزیم Q10 بر شاخص های خونی التهابی و اکسیدانی و سطح فعالیت بتاسکرتاز در بیماران دیابتی مبتلا به رتینوپاتی
    Evaluation of the effect of Coenzyme Q10 on visual field,cognition abilities and serum levels of Beta secretase and oxidative factors in acute ischemic stroke patients with visual field defects
    Evaluation the effect of coenzyme Q10 and placebo on blood inflammatory and oxidant factors and beta-secretase activity levels in diabetic retinopathy patients
    بررسی اثر کوانزیم Q10 بر میدان بینایی، توانایی‌های شناختی، سطوح بتا سکرتاز و شاخص‌های اکسیداتیو سرمی بیماران استروک ایسکمیک حاد دچار نقص میدان بینایی
    بررسی اثر کوانزیم Q10 و پلاسبو بر شاخص های خونی التهابی و اکسیدانی و سطح فعالیت بتاسکرتاز در بیماران دیابتی مبتلا به رتینوپاتی
    Acute ischemic stroke patients with visual field defects
    diabetic retinopathy patients
    بیماران استروک حاد ایسکمیک مبتلا به نقص میدان بینایی
    بیماران دیابتی مبتلا به رتینوپاتی
    Other neurological diseases such as Alzheimer's and MS
    Other effective ocular disease and neurological diseases such as Alzheimer's and MS
    سایر بیماری های نورولوژیک از قبیل آلزایمر و ام اس
    سایر بیماری های چشمی موثر و تیز بیماری های نورولوژیک از قبیل آلزایمر و ام اس

Protocol summary

Study aim
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.
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
1)Coenzyme Q10 ,n=32 2)Placebo ,n=32
Main outcome variables
Inflammatory and oxidant factors and beta secretase activity levels of serum

General information

Reason for update
change in proposal For operational and feasibility reasons
Acronym
IRCT registration information
IRCT registration number: IRCT20160524028046N2
Registration date: 2022-03-18, 1400/12/27
Registration timing: prospective

Last update: 2025-05-08, 1404/02/18
Update count: 2
Registration date
2022-03-18, 1400/12/27
Registrant information
Name
Mohammad Hossein Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3252 0182
Email address
mhsharif2013@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2026-03-06, 1404/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of coenzyme Q10 and placebo on blood inflammatory and oxidant factors and beta-secretase activity levels in diabetic retinopathy patients
Public title
Evaluation the effect of coenzyme Q10 on blood inflammatory and oxidant factors and beta-secretase activity levels in diabetic retinopathy patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
diabetic retinopathy patients
Exclusion criteria:
Other effective ocular disease and neurological diseases such as Alzheimer's and MS
Age
From 40 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Pajoohesh
City
Hamedan
Province
Hamadan
Postal code
6517838736
Approval date
2022-03-06, 1400/12/15
Ethics committee reference number
IR.UMSHA.REC.1400.969

Health conditions studied

1

Description of health condition studied
Stroke
ICD-10 code
8B11
ICD-10 code description
Cerebral ischaemic stroke

Primary outcomes

1

Description
Visual field
Timepoint
Monthly
Method of measurement
perimetry

Secondary outcomes

1

Description
serum beta secretase
Timepoint
Monthly
Method of measurement
Assay kit

2

Description
Quality of life based on vision
Timepoint
Monthly
Method of measurement
questionnaire

3

Description
Contrast sensitivity
Timepoint
monthly
Method of measurement
Freiburg CS Test

4

Description
oxidant Status
Timepoint
Monthly
Method of measurement
Assay kit

5

Description
Antioxidant Status
Timepoint
Monthly
Method of measurement
Assay kit

6

Description
Visual Acuity
Timepoint
Weekly
Method of measurement
Snellen chart

Intervention groups

1

Description
Intervention group:Patients will be treated with Coenzyme Q10 soft gel prepared from jalinus Pharmaceutical Company (Tehran-Iran),orally (10 mg/kg), daily for 30 days
Category
Treatment - Drugs

2

Description
Control group: Placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Ehsan Sharifipour
Street address
Shahid Beheshti
City
Qom
Province
Ghoum
Postal code
3716993456
Phone
+98 25 3285 2720
Email
sharifipour.e@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abdolrahman Sarihi
Street address
Pajoohesh
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
sarihi@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Ghoum University of Medical Sciences
Full name of responsible person
Ehsan Sharifipour
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Safa Shahr
City
Qom
Province
Ghoum
Postal code
3716993456
Phone
+98 25 3285 2720
Email
sharifipour.e@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
َAbdolrahman Sarihi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Pajoohesh
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
sarihi@umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohamad Hossein Sharif
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
Pajoohesh
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
mhsharif2013@gmail.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
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