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IRCT20150606022562N6 IRCT 2019-02-11 Kashan University of Medical Sciences The effect of Nano-curcumin in patients with diabetic hemodialysis The effects of Nano-curcumin on metabolic status in patients with diabetes on hemodialysis 2018-11-06 anticipated 60 Complete https://irct.ir/trial/33447 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: At study baseline, after balanced blocked randomisation, particpants will be allocated into two groups to take either Nano-curcumin supplements (n = 30) or placebos (n = 30). Randomization will be done by the use of computer-generated random numbers, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. 3 Chronic kidney disease. Intervention 1: Intervention group: receiving one 80 mg Nano-curcumin capsule per day for 12 weeks. Intervention 2: Control group: Placebo oral capsule, daily, for 12 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Fereshteh Bahmani
Medical Faculty, Kashan University of Medical Sciences, Ravand road
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5554 0021 bahmani@kaums.ac.ir Kashan University of Medical Sciences scientific Fereshteh Bahmani
Medical Faculty, Kashan University of Medical Sciences, Ravand road
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5554 0021 fbahmani@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Diabetic hemodialysis patients Aged 18to 80 years 18 years 80 years Both Patients suffering from infectious, inflammatory and malignant diseases. Patients taking curcumin supplements, antioxidant and/or anti-inflammatory supplements within 3 months before participation in the study. subjects receiving immunosuppressive and antibiotics medications. N18.5 Chronic kidney disease, stage 5 Treatment - Drugs Placebo Intervention group: receiving one 80 mg Nano-curcumin capsule per day for 12 weeks Control group: Placebo oral capsule, daily, for 12 weeks. Insulin. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: Elisa kit. Insulin resistance. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Calculation using HOMA formula. Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. High-density lipoprotein-cholesterol (HDL-Cholesterol). Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. High sensitive-C-reactive protein (hs-CRP). Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. Total Nitric Oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Expression levels of PPAR-γ gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Real-Time PCR. Expression levels of LDLR gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Real-Time PCR Method. Gluthatione. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: Spectrophotometry. Total antioxidant capacity. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: Spectrophotometry. Malondialdehyde. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: Spectrophotometry. Expression levels of TGF-β gene. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: Real-Time PCR Method. Fasting blood sugar. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. VLDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. LDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. BUN. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Creatinine. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. AGEs. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Systolic blood pressure (SBP). Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Sphygmomanometer. Diastolic blood pressure (DBP). Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Sphygmomanometer. Kashan University of Medical Sciences Approved 2018-11-05 Ethics Committee of Kashan University of Medical Sciences and Health Services Kashan University of Medical Sciences, Ravand road Kashan Isfehan Iran (Islamic Republic of)