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IRCT20230823059232N2 IRCT 2024-05-16 Zanjan University of Medical Sciences Investigating the effect of curcumin-piperine supplementation on interleukin 6 and oxidative stress index in diabetic nephropathy patients Investigating the effect of curcumin-piperine supplementation on interleukin 6 and oxidative stress index in diabetic nephropathy patients 2024-05-21 anticipated 60 Complete https://irct.ir/trial/73211 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Other, Randomization description: Random Allocation software was used to randomize the sample into two treatment and placebo groups. Output of mentioned software includes a table that shows the number of each patient is located in each group (intervention or placebo), Blinding description: This study has been designed as double-blind and persons including participants, and investigators, were kept unaware of the treatment administered. Drug and placebo vials have similar packaging and labeling and all recorded data will be encoded in the questionnaires and software. 3 Type 2 diabetic patients with nephropathy. Intervention 1: Intervention group: 500m/gram curcumin per day for 3 months. Intervention 2: Control group: Placebo (500 mg of lactose) to be consumed daily for 3 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is ecause the participant’s informations should remain confidental.
public Amirhossein Sahebkar
The end of Shahid Fakuri Blvd
Mashhad Iran (Islamic Republic of) 9177899191 +98 915 122 1496 amir_saheb2000@yahoo.com Mashhad University of Medical Sciences scientific Kamyar Mansouri
Mahdavi
Zanjan Iran (Islamic Republic of) 4513956184 +98 912 441 8600 kamyarmansori@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age ≥18 years Type 2 diabetes and nephropathy Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 Controlled HTN (systolic). blood pressure [BP] <140 and diastolic blood pressure <90) 18 years no limit Both History of gallstones and biliary obstruction Kidney transplant treatment Autoimmune disease or malignancy pregnancy liver damage History of organ transplantation E08 Diabetes mellitus due to underlying condition Treatment - Other Treatment - Other Intervention group: 500m/gram curcumin per day for 3 months Control group: Placebo (500 mg of lactose) to be consumed daily for 3 months Fasting blood suger. Timepoint: From the beginning of the study (before the start of the intervention) and 90 days after the start of the curcumin-piperine supplement. Method of measurement: Enzymatic method using a kit. Creatinine. Timepoint: From the beginning of the study (before the start of the intervention) and 90 days after the start of the curcumin-piperine supplement. Method of measurement: Enzymatic method using a kit. Urine albumine. Timepoint: From the beginning of the study (before the start of the intervention) and 90 days after the start of the curcumin-piperine supplement. Method of measurement: Turbidometry. Malondialdehyde. Timepoint: From the beginning of the study (before the start of the intervention) and 90 days after the start of the curcumin-piperine supplement. Method of measurement: Eliza. Superoxide dismutase. Timepoint: From the beginning of the study (before the start of the intervention) and 90 days after the start of the curcumin-piperine supplement. Method of measurement: eliza. Interleukin 6. Timepoint: From the beginning of the study (before the start of the intervention) and 90 days after the start of the curcumin-piperine supplement. Method of measurement: eliza. HbA1C. Timepoint: From the beginning of the study (before the start of the intervention) and 90 days after the start of the curcumin-piperine supplement. Method of measurement: Enzymatic method using a kit. Zanjan University of Medical Sciences Approved 2023-11-21 Ethics Committee Of Zanjan University Of Medical Sciences Valiasr hospital zanjan Zanjan Iran (Islamic Republic of)