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IRCT20201129049534N5 IRCT 2021-09-11 Esfahan University of Medical Sciences Effect of curcumin piperine in patients with non-proliferative diabetic retinopathy 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. 2021-10-06 anticipated 50 Complete https://irct.ir/trial/56564 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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), Blinding description: 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. 2 Diabetic retinopathy. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Study information will be published after the individuals are unidentified and after the project is completed. When: Access period starts six months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: For further analysis Where to obtain: Dr. Mohammad Baghernia bagherniya@nutr.mui.ac.ir How to obtain: After reviewing the request and making it fully clear about the purposes of using the data, the data will be provided. Comments:
public Mohammad Bagherniya
Hezar-jerib Ave, Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3972 3138 bagherniya@nutr.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammad Bagherniya
Hezar-jerib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3183 bagherniya@nutr.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) 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%) 30 years 65 years Both 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. E08.3 Diabetes mellitus due to underlying condition with ophthalmic complications Treatment - Drugs Placebo 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. 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. Macular artery density. Timepoint: At baseline and end of the study. Method of measurement: OCTA (Optical Coherence Tomography angiography) device. C reactive Protein (CRP). Timepoint: At baseline and end of the study. Method of measurement: ELISA test. Superoxide dismutase. Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit. Total antioxidant capacity. Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit. Fasting blood sugar. Timepoint: At baseline and end of the study. Method of measurement: ELISA test. Triglycerides. Timepoint: At baseline and end of the study. Method of measurement: ELISA test. Malondialdehyde. Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit. Blood urea nitrogen (BUN). Timepoint: At baseline and end of the study. Method of measurement: ELISA test. Creatinine (Cr). Timepoint: At baseline and end of the study. Method of measurement: ELISA test. Sleep Quality. Timepoint: At baseline and end of the study. Method of measurement: Pittsburgh sleep quality index (PSQI) questionnaire. Emotional status (stress, anxiety, and depression). Timepoint: At baseline and end of the study. Method of measurement: DASS-21 questionnaire. Weight. Timepoint: At baseline and end of the study. Method of measurement: Digital Scale. Esfahan University of Medical Sciences Approved 2021-09-04 Ethics committee Vice-Chancellor in Research Affairs -Medical University of Isfahan School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Hezar-jerib Avenue Isfahan Isfehan Iran (Islamic Republic of)