Effect of curcumin supplementation on serum levels of advanced glycation end products , tumor necrosis factor alpha and metabolic indices in patients with diabetic retinopathy
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
Recruitment centers
#1
Name of recruitment center - English: بیمارستان چشم نیکوکاری تبریز
Name of recruitment center - Persian: tabriz nikukari eye hospital
Full name of responsible person - English: nima radkhah
Full name of responsible person - Persian: نیما رادخواه
Street address - English: 17 shahrivar ave-mehran alley- 31 no.
Street address - Persian: 17 شهریور-کوچه مهران- پلاک 31
City - English: تبریز
City - Persian: tabriz
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5137836371
Phone: +98 41 3555 0986
Fax:
Email: n.radkhah@gmail.com
Web page address:
Name of recruitment center - English: Tabriz Nikukari eye hospital
Name of recruitment center - Persian: بیمارستان چشم نیکوکاری تبریز
Full name of responsible person - English: Nima Radkhah
Full name of responsible person - Persian: نیما رادخواه
Street address - English: Daneshgah Street
Street address - Persian: خیابان دانشگاه
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5136782465
Phone: +98 41 3355 0915
Fax:
Email: N.radkhah@gmail.com
Web page address:
Name of recruitment center - English: بیمارستان چشم نیکوکاری تبریزTabriz Nikukari eye hospital Name of recruitment center - Persian: tabriz nikukari eye hospitalبیمارستان چشم نیکوکاری تبریز Full name of responsible person - English: nima radkhahNima Radkhah Full name of responsible person - Persian: نیما رادخواه Street address - English: 17 shahrivar ave-mehran alley- 31 no.Daneshgah Street Street address - Persian: 17 شهریور-کوچه مهران- پلاک 31خیابان دانشگاه City - English: تبریزTabriz City - Persian: tabrizتبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 51378363715136782465 Phone: +98 41 3555 09863355 0915 Fax: Email: n.radkhahN.radkhah@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: abulgaseme juyban
Full name of responsible person - Persian: ابوالقاسم جویبان
Street address - English: 17 shahrivar ave-mehran alley- 31 no.
Street address - Persian: 17 شهریور کوچه مهران پلاک 31
City - English: tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5137836371
Phone: +98 41 3555 0986
Fax:
Email: n.radkhah@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Abulgaseme Juyban
Full name of responsible person - Persian: ابوالقاسم جویبان
Street address - English: Daneshgah street
Street address - Persian: خیابان دانشگاه
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5136782465
Phone: +98 41 3335 0914
Fax:
Email: N.radkhah@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: abulgaseme juybanAbulgaseme Juyban Full name of responsible person - Persian: ابوالقاسم جویبان Street address - English: 17 shahrivar ave-mehran alley- 31 no.Daneshgah street Street address - Persian: 17 شهریور کوچه مهران پلاک 31خیابان دانشگاه City - English: tabrizTabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 51378363715136782465 Phone: +98 41 3555 09863335 0914 Fax: Email: n.radkhahN.radkhah@gmail.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: Nima Radkhah
Full name of responsible person - Persian: نیما رادخواه
Position - English: Student
Position - Persian: دانشجو
Latest degree: bachelor
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 17 Shahrivar Ave-Mehran Alley- 31 No.
Street address - Persian: 17 شهریور-کوچه مهران پلاک 31
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5137836371
Phone: +98 41 3555 0986
Mobile: +98 914 629 0869
Fax:
Email: N.radkhah@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Nima Radkhah
Full name of responsible person - Persian: نیما رادخواه
Position - English: Student
Position - Persian: دانشجو
Latest degree: bachelor
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Daneshgah Street
Street address - Persian: خیابان دانشگاه
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5136782465
Phone: +98 41 3335 0914
Mobile: +98 914 629 0869
Fax:
Email: N.radkhah@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Nima Radkhah Full name of responsible person - Persian: نیما رادخواه Position - English: Student Position - Persian: دانشجو Latest degree: bachelor Area of specialty/work: 34 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: 17 Shahrivar Ave-Mehran Alley- 31 No.Daneshgah Street Street address - Persian: 17 شهریور-کوچه مهران پلاک 31خیابان دانشگاه City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 51378363715136782465 Phone: +98 41 3555 09863335 0914 Mobile: +98 914 629 0869 Fax: Email: N.radkhah@gmail.com Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Nima Radkhah
Full name of responsible person - Persian: نیما رادخواه
Position - English: Student
Position - Persian: دانشجو
Latest degree: bachelor
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 17 Shahrivar Ave-Mehran Alley- 31 No.
Street address - Persian: 17 شهریور کوچه مهران پلاک 31
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5137836371
Phone: +98 41 3555 0986
Mobile: +98 914 629 0869
Fax:
Email: N.radkhah@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Nima Radkhah
Full name of responsible person - Persian: نیما رادخواه
Position - English: Student
Position - Persian: دانشجو
Latest degree: bachelor
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Daneshgah Street
Street address - Persian: خیابان دانشگاه
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5136782465
Phone: +98 41 3335 0914
Mobile: +98 914 629 0869
Fax:
Email: N.radkhah@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Nima Radkhah Full name of responsible person - Persian: نیما رادخواه Position - English: Student Position - Persian: دانشجو Latest degree: bachelor Area of specialty/work: 34 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: 17 Shahrivar Ave-Mehran Alley- 31 No.Daneshgah Street Street address - Persian: 17 شهریور کوچه مهران پلاک 31خیابان دانشگاه City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 51378363715136782465 Phone: +98 41 3555 09863335 0914 Mobile: +98 914 629 0869 Fax: Email: N.radkhah@gmail.com Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Nima Radkhah
Full name of responsible person - Persian: نیما رادخواه
Position - English: Student
Position - Persian: دانشجو
Latest degree: bachelor
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 17 Shahrivar Street. Mehran Alley. 31 No.
Street address - Persian: شریعتی جنوبی- کوچه مهران- پلاک 31
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5137836371
Phone: +98 41 3555 0986
Mobile: +98 914 629 0869
Fax:
Email: N.radkhah@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Nima Radkhah
Full name of responsible person - Persian: نیما رادخواه
Position - English: Student
Position - Persian: دانشجو
Latest degree: bachelor
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Daneshgah Street
Street address - Persian: خیابان دانشگاه
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5136782465
Phone: +98 41 3335 0914
Mobile: +98 914 629 0869
Fax:
Email: N.radkhah@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Nima Radkhah Full name of responsible person - Persian: نیما رادخواه Position - English: Student Position - Persian: دانشجو Latest degree: bachelor Area of specialty/work: 34 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: 17 ShahrivarDaneshgah Street. Mehran Alley. 31 No. Street address - Persian: شریعتی جنوبی- کوچه مهران- پلاک 31خیابان دانشگاه City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 51378363715136782465 Phone: +98 41 3555 09863335 0914 Mobile: +98 914 629 0869 Fax: Email: N.radkhah@gmail.com Web page address:
Protocol summary
Study aim
To determine the effect of curcumin on serum levels of advanced glycation end products, tumor necrosis factor alpha in patients with diabetic retinopathy
Design
Randomized double-blind clinical trial with two arm parallel groups, phase 3 trial
Settings and conduct
The trial will be conducted at outpatient clinic of Nikukari affiliated to Tabriz University of Medical Sciences, Iran. All the patients will be screened by an expert retin for eligibility. Those willing to take part in the study will be carefully evaluated with reference to inclusion criteria. A third party who is blind to the study will give the sequence extracted from allocation software. After an overnight fasting, blood will be collected and curcumin supplements will be provided to the participants. supplementation duration will be 8 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
People with diabetic retinopathy
Age range 40 to 70 years old
Exclusion criteria:
Receiving insulin
Cases of chronic diseases such as cardiovascular, renal and hepatic disorders
malabsorption syndrome and inflammatory bowel disease
Having certain physiological conditions like pregnancy and breastfeeding
Intervention groups
Patients in the intervention group will use a curcumin capsule with their lunch, daily. In the control group, patients will use a placebo capsule with their lunch.
Main outcome variables
Advanced Glycation End Products such as Methylglyoxal, Pentosidine, Carboxymehyllysine and Tumor Necrosis Factor Alpha
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121208011689N6
Registration date:2018-09-30, 1397/07/08
Registration timing:retrospective
Last update:2023-08-20, 1402/05/29
Update count:1
Registration date
2018-09-30, 1397/07/08
Registrant information
Name
Sorayya Kheirouri
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
kheirouris@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of curcumin supplementation on serum levels of advanced glycation end products , tumor necrosis factor alpha and metabolic indices in patients with diabetic retinopathy
Public title
Effect of Curcumin in treatment of diabetic complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Desire to cooperate and sign informed consent form after full knowledge of the goals and method of implementation of the study
Age between 40 to 70 years old
People with diabetic retinopathy without insulin
Exclusion criteria:
Receiving insulin
Cases of chronic diseases such as cardiovascular, renal and hepatic disorders
Malabsorption syndrome and inflammatory bowel disease (Crohn's disease, celiac sproctomy, short stomach and biliary tract jejuni-ileal syndrome)
Having certain physiological conditions like pregnancy and breastfeeding
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The eligible participants will be randomly allocated to intervention and placebo groups using a software generated random blocks. The generated random sequence will be administered by an independent third party who is blind to the trial throughout the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, patient and investigator will not be aware of the treatment assignments for the duration of the study. For blinding the trial, the curcumin capsules and placebo, will be identical in appearance, packaging, and labeling. All capsules will be packed and encoded by the company.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sience
Street address
Daneshgah Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5136782465
Approval date
2018-06-11, 1397/03/21
Ethics committee reference number
IR.TBZMED.REC.1397.235
Health conditions studied
1
Description of health condition studied
People with diabetic retinopathy
ICD-10 code
H36.0
ICD-10 code description
Diabetic retinopathy
Primary outcomes
1
Description
Serum level of methylglyoxal
Timepoint
First of study and in the end of study
Method of measurement
Elisa
Secondary outcomes
1
Description
Serum levels of Pentosidine
Timepoint
At the beginning of the study and 8 weeks later
Method of measurement
Elisa
2
Description
Serum level of Carboxymehtyllyzine
Timepoint
At the beginning of the study and 8 weeks later
Method of measurement
Elisa
3
Description
Serum level of tumor necrosis factor alpha
Timepoint
At the beginning of the study and 8 weeks later
Method of measurement
Elisa
Intervention groups
1
Description
Intervention group: Patients in this group will receive curcumin capsule for 8 weeks. curcumin capsule is used once a day with lunch.
Category
Treatment - Drugs
2
Description
Control group:Patients in this group will receive placebo capsules for 8 weeks which are same size and shape and used once a day with lunch.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Nikukari eye hospital
Full name of responsible person
Nima Radkhah
Street address
Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5136782465
Phone
+98 41 3355 0915
Email
N.radkhah@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abulgaseme Juyban
Street address
Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5136782465
Phone
+98 41 3335 0914
Email
N.radkhah@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Nima Radkhah
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5136782465
Phone
+98 41 3335 0914
Email
N.radkhah@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nima Radkhah
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5136782465
Phone
+98 41 3335 0914
Email
N.radkhah@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nima Radkhah
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5136782465
Phone
+98 41 3335 0914
Email
N.radkhah@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of data about primary consequnece
When the data will become available and for how long
Six month after results published
To whom data/document is available
Researcher who are working in university institutes
Under which criteria data/document could be used
Only for meta-analysis studies data will be available to other researchers.
From where data/document is obtainable
By my gmail n.radkhah@gmail.com
What processes are involved for a request to access data/document