Protocol summary
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Study aim
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To determine the effect of curcumin on serum levels of advanced glycation end products, tumor necrosis factor alpha in patients with diabetic retinopathy
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Design
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Randomized double-blind clinical trial with two arm parallel groups, phase 3 trial
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Advanced Glycation End Products such as Methylglyoxal, Pentosidine, Carboxymehyllysine and Tumor Necrosis Factor Alpha
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2018-09-30, 1397/07/08
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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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2017-03-21, 1396/01/01
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Expected recruitment end date
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2017-08-23, 1396/06/01
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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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Effect of curcumin supplementation on serum levels of advanced glycation end products , tumor necrosis factor alpha and metabolic indices in patients with diabetic retinopathy
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Public title
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Effect of Curcumin in treatment of diabetic complications
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 40 years old to 70 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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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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2018-06-11, 1397/03/21
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Ethics committee reference number
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IR.TBZMED.REC.1397.235
Health conditions studied
1
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Description of health condition studied
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People with diabetic retinopathy
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ICD-10 code
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H36.0
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ICD-10 code description
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Diabetic retinopathy
Primary outcomes
1
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Description
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Serum level of methylglyoxal
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Timepoint
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First of study and in the end of study
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Method of measurement
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Elisa
Secondary outcomes
1
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Description
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Serum levels of Pentosidine
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Timepoint
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At the beginning of the study and 8 weeks later
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Method of measurement
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Elisa
2
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Description
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Serum level of Carboxymehtyllyzine
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Timepoint
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At the beginning of the study and 8 weeks later
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Method of measurement
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Elisa
3
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Description
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Serum level of tumor necrosis factor alpha
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Timepoint
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At the beginning of the study and 8 weeks later
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Method of measurement
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Elisa
Intervention groups
1
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Description
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Intervention group: Patients in this group will receive curcumin capsule for 8 weeks. curcumin capsule is used once a day with lunch.
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Category
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Treatment - Drugs
2
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Description
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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.
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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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Tabriz 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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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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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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Part of data about primary consequnece
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When the data will become available and for how long
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Six month after results published
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To whom data/document is available
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Researcher who are working in university institutes
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Under which criteria data/document could be used
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Only for meta-analysis studies data will be available to other researchers.
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From where data/document is obtainable
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By my gmail n.radkhah@gmail.com
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What processes are involved for a request to access data/document
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As soon as possible
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Comments
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