Protocol summary
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Study aim
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Determination of the effect of curcumin-piperine supplementation on cardiometabolic, inflammatory and oxidative stress factors and macular vascular density in optical coherence tomography angiography (OCTA) in patients with non-proliferative diabetic retinopathy.
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Design
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Clinical trial, randomized, double-blind, randomized control group of 50 patients. Randomization is done using a valid website and 4-block method.
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Settings and conduct
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This clinical trial will be performed in the special clinic of Feyz Hospital. Curcumin piperine and placebo are given to the patient in exactly the same packages. Patients and researchers will not be aware of the type of intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria
• Age 30 to 65 years
Diagnosis of diabetic retinopathy with the approval of an ophthalmologist, imaging, CT scan or PCR
Definitive diagnosis of diabetes by a diabetic doctor (fasting blood sugar above 126 mg / dL measured twice or HbA1C greater than or equal to 6.5%)
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Intervention groups
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Intervention group: Capsules containing curcumin-piperine each containing 500 mg of curcumin and 5 mg of piperine twice a day. control group 2 capsules each containing 500 mg of maltodextrin
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Main outcome variables
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Before and after the intervention; fasting blood glucose , macular vascular density using optical coherence tomography angiography (OCTA), blood CRP, oxidative stress indices including total antioxidant capacity (TAC) and total oxidative capacity (TOS) and index Kidneys including creatinine, BUN, and blood triglycerides are evaluated.
General information
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Reason for update
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Due to the lack of access to the oxidative stress kit (TOS), there were minor changes in the outcomes.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201129049534N5
Registration date:
2021-09-11, 1400/06/20
Registration timing:
prospective
Last update:
2023-05-18, 1402/02/28
Update count:
1
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Registration date
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2021-09-11, 1400/06/20
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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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2021-10-06, 1400/07/14
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Expected recruitment end date
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2022-10-06, 1401/07/14
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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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The effect of curcumin-piperine supplementation on cardiometabolic, inflammatory and oxidative stress factors and macular vascular density in optical coherence tomography angiography (OCTA) in patients with non-proliferative diabetic retinopathy.
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Public title
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Effect of curcumin piperine in patients with non-proliferative diabetic retinopathy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age 30 to 65 years
Diagnosis of diabetic retinopathy with the approval of an ophthalmologist, imaging, CT scan or PCR
Definitive diagnosis of diabetes by a diabetic doctor (fasting blood sugar above 126 mg / dL measured twice or HbA1C greater than or equal to 6/5%)
Exclusion criteria:
Sensitivity to plant products such as turmeric and pepper
Follow a special diet in the last 3 months
Taking anticoagulants such as heparin, warfarin, aspirin, etc.
Pregnancy and lactation
Patient dissatisfaction
Taking herbal medicines or supplements in the last 3 months
Requires the use of anti-VEGF (Anti–vascular endothelial growth factor)
Use of therapies including laser therapy, surgery and intraocular injections
Having certain diseases such as congenital diseases, type 1 diabetes, immune deficiency, cancer
Uncontrolled diabetes
Consume less than 80% of the curcumin piperine supplement
Report any adverse side effects after taking supplements
If other treatments of the patient such as treatment of hypertension, hyperlipidemia, etc. are variable during the course of treatment.
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Age
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From 30 years old to 65 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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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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Randomization is done individually. Entry of each patient into the intervention or control group is done randomly with the help of 4 blocking. This is done using a reputable random number generation website. (Random number generation website:
https://www.sealedenvelope.com/simple-randomiser/v1/lists)
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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 double blinded so that the researcher and the subjects will not know which group they belong to. For blinding, curcumin piperine and placebo capsules are prepared in the same shape, color and size. These capsules are coded by someone other than the researchers (A and B) and then the capsules are given to patients. Until the end of the study and after analyzing the data, researchers will not know about the intervention and control groups.
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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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2021-09-04, 1400/06/13
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Ethics committee reference number
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IR.MUI.RESEARCH.REC.1400.253
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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E08.3
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ICD-10 code description
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Diabetes mellitus due to underlying condition with ophthalmic complications
Primary outcomes
1
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Description
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Macular artery density
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Timepoint
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At baseline and end of the study
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Method of measurement
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OCTA (Optical Coherence Tomography angiography) device
2
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Description
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C reactive Protein (CRP)
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Timepoint
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At baseline and end of the study
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Method of measurement
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ELISA test
3
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Description
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Superoxide dismutase
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Timepoint
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At baseline and end of the study
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Method of measurement
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Commercial diagnostic kit
4
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Description
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Total antioxidant capacity
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Timepoint
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At baseline and end of the study
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Method of measurement
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Commercial diagnostic kit
5
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Description
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Fasting blood sugar
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Timepoint
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At baseline and end of the study
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Method of measurement
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ELISA test
6
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Description
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triglycerides
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Timepoint
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At baseline and end of the study
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Method of measurement
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ELISA test
7
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Description
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Malondialdehyde
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Timepoint
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At baseline and end of the study
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Method of measurement
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Commercial diagnostic kit
Secondary outcomes
1
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Description
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Blood urea nitrogen (BUN)
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Timepoint
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At baseline and end of the study
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Method of measurement
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ELISA test
2
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Description
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Creatinine (Cr)
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Timepoint
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At baseline and end of the study
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Method of measurement
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ELISA test
3
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Description
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Sleep Quality
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Timepoint
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At baseline and end of the study
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Method of measurement
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Pittsburgh sleep quality index (PSQI) questionnaire
4
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Description
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Emotional status (stress, anxiety, and depression)
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Timepoint
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At baseline and end of the study
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Method of measurement
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DASS-21 questionnaire
5
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Description
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Weight
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Timepoint
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At baseline and end of the study
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Method of measurement
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Digital Scale
Intervention groups
1
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Description
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Intervention group: Intervention group will receive a capsule containing curcumin-piperine in the amount of 500 mg of curcumin and 5 mg of piperine twice a day after breakfast and in the evening (a total of 1000 mg of curcumin and 10 mg of piperine daily) for 12 weeks.
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Category
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Treatment - Drugs
2
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Description
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Control group: The control group will receive capsules (2 capsules) containing placebo. Each capsule contains 500 mg of maltodextrin (a total of 1000 mg of maltodextrin daily) for 12 weeks.
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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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Esfahan 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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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Study information will be published after the individuals are unidentified and after the project is completed.
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When the data will become available and for how long
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Access period starts six months after the results are published
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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For further analysis
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From where data/document is obtainable
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Dr. Mohammad Baghernia bagherniya@nutr.mui.ac.ir
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What processes are involved for a request to access data/document
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After reviewing the request and making it fully clear about the purposes of using the data, the data will be provided.
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Comments
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