Evaluation the effect of coenzyme Q10 and placebo on blood inflammatory and oxidant factors and beta-secretase activity levels in diabetic retinopathy patients
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Health conditions studied
#1
8B11
E08.31
8B11E08.31
Cerebral ischaemic stroke
Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy
Cerebral ischaemic strokeDiabetes mellitus due to underlying condition with unspecified diabetic retinopathy
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
Intervention group:Patients will be treated with Coenzyme Q10 soft gel prepared from jalinus Pharmaceutical Company (Tehran-Iran),orally (200mg), daily for 120 days
Intervention group:Patients will be treated with Coenzyme Q10 soft gel prepared from jalinus Pharmaceutical Company (Tehran-Iran),orally (10 mg/kg200mg), daily for 30120 days
گروه مداخله: سافت ژل کوانزیم کیوتن تهیه شده از شرکت داروسازی جالینوس(ایران-تهران)،بصورت خوراکی به میزان ۱۰میلی گرم به ازای هرکیلوگرم وزن روزانه و به مدت ۳۰ روز
گروه مداخله: سافت ژل کوانزیم کیوتن تهیه شده از شرکت داروسازی جالینوس(ایران-تهران)،بصورت خوراکی به میزان ۲۰۰ میلی گرم روزانه و به مدت 120روز
گروه مداخله: سافت ژل کوانزیم کیوتن تهیه شده از شرکت داروسازی جالینوس(ایران-تهران)،بصورت خوراکی به میزان ۱۲۰۰ میلی گرم به ازای هرکیلوگرم وزن روزانه و به مدت ۳۰ روز120روز
#2
گروه کنترل: بیماران با دارونما با همان شکل ظاهری و بصورت خوراکی به مدت ۳۰ روز درمان خواهند شد.
گروه کنترل: بیماران با دارونما با همان شکل ظاهری و بصورت خوراکی به مدت 120 روز درمان خواهند شد.
گروه کنترل: بیماران با دارونما با همان شکل ظاهری و بصورت خوراکی به مدت ۳۰120 روز درمان خواهند شد.
Recruitment centers
#1
Name of recruitment center - English: Shahid Beheshti Hospital
Name of recruitment center - Persian: بیمارستان شهید بهشتی
Full name of responsible person - English: Ehsan Sharifipour
Full name of responsible person - Persian: احسان شریفی پور
Street address - English: Shahid Beheshti
Street address - Persian: شهید بهشتی
City - English: Qom
City - Persian: قم
Province: Ghoum
Country: Iran (Islamic Republic of)
Postal code: 3716993456
Phone: +98 25 3285 2720
Fax:
Email: sharifipour.e@yahoo.com
Web page address:
Name of recruitment center - English: Taban Eye Clinic
Name of recruitment center - Persian: کلینیک چشم پزشکی تابان
Full name of responsible person - English: Fatemeh Javadian
Full name of responsible person - Persian: فاطمه جوادیان
Street address - English: Boo Ali Sina
Street address - Persian: بوعلی سینا
City - English: Qom
City - Persian: قم
Province: Ghoum
Country: Iran (Islamic Republic of)
Postal code: 3716615198
Phone: +98 25 3294 5000
Fax:
Email: tabanCl-Qom@gmail.com
Web page address:
Name of recruitment center - English: Shahid Beheshti HospitalTaban Eye Clinic Name of recruitment center - Persian: بیمارستان شهید بهشتیکلینیک چشم پزشکی تابان Full name of responsible person - English: Ehsan SharifipourFatemeh Javadian Full name of responsible person - Persian: احسان شریفی پورفاطمه جوادیان Street address - English: Shahid BeheshtiBoo Ali Sina Street address - Persian: شهید بهشتیبوعلی سینا City - English: Qom City - Persian: قم Province: Ghoum Country: Iran (Islamic Republic of) Postal code: 37169934563716615198 Phone: +98 25 3285 27203294 5000 Fax: Email: sharifipour.etabanCl-Qom@yahoo.comgmail.com Web page address:
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ehsan Sharifipour
Full name of responsible person - Persian: احسان شریفی پور
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree: specialist
Area of specialty/work: 86
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Safa Shahr
Street address - Persian: صفاشهر
City - English: Qom
City - Persian: قم
Province: Ghoum
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3716993456
Phone: +98 25 3285 2720
Mobile: +98 912 503 5828
Fax:
Email: sharifipour.e@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Abdolrahman Sarihi
Full name of responsible person - Persian: عبدالرحمن صریحی
Position - English: Professor
Position - Persian: استاد
Latest degree: phd
Area of specialty/work: 63
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Pajoohesh
Street address - Persian: پژوهش
City - English: Hamadan
City - Persian: همدان
Province: Hamadan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: ۶۵۱۷۸۳۸۷۳۶
Phone: +98 81 3131 0000
Mobile: +98 913122098
Fax:
Email: sarihi@umsha.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Ehsan SharifipourAbdolrahman Sarihi Full name of responsible person - Persian: احسان شریفی پورعبدالرحمن صریحی Position - English: Associate Professor Position - Persian: دانشیاراستاد Latest degree: specialistphd Area of specialty/work: 8663 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Safa ShahrPajoohesh Street address - Persian: صفاشهرپژوهش City - English: QomHamadan City - Persian: قمهمدان Province: GhoumHamadan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 3716993456۶۵۱۷۸۳۸۷۳۶ Phone: +98 25 3285 272081 3131 0000 Mobile: +98 912 503 5828913122098 Fax: Email: sharifipour.esarihi@yahoo.comumsha.ac.ir Web page address:
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:2025-05-12, 1404/02/22
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
Diabetic Retinopathy
ICD-10 code
E08.31
ICD-10 code description
Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy
Primary outcomes
1
Description
Inflammatory/Anti Inflammatory factors
Timepoint
pre and post Treatment
Method of measurement
Elisa Kits
2
Description
Oxidant /Anti Oxidant Factors
Timepoint
pre and post Treatment
Method of measurement
Elisa kits
3
Description
serum Beta secretase activity
Timepoint
pre and post Treatment
Method of measurement
Elisa Kit
Secondary outcomes
1
Description
Blood pressure
Timepoint
pre and post Treatment
Method of measurement
Standard Barometer
Intervention groups
1
Description
Intervention group:Patients will be treated with Coenzyme Q10 soft gel prepared from jalinus Pharmaceutical Company (Tehran-Iran),orally (200mg), daily for 120 days
Category
Treatment - Drugs
2
Description
Control group: Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taban Eye Clinic
Full name of responsible person
Fatemeh Javadian
Street address
Boo Ali Sina
City
Qom
Province
Ghoum
Postal code
3716615198
Phone
+98 25 3294 5000
Email
tabanCl-Qom@gmail.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
Hamedan University of Medical Sciences
Full name of responsible person
Abdolrahman Sarihi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Pajoohesh
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
sarihi@umsha.ac.ir
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