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IRCT20130903014551N4 IRCT 2019-10-20 Esfahan University of Medical Sciences The effect of curcumin supplementation on cardiovascular factors and kidney function on patients with chronic kidney disease CKD The effect of curcumin supplementation on cardiovascular risk factors and kidney function on patients with stage 3 and 4 of chronic kidney disease (CKD) 2019-07-22 anticipated 60 Complete https://irct.ir/trial/40913 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done through the randomization blocking method (permuted blocked randomization). Considering the sample size, each block includes 4 characters and will use AAAB combination. In the following, all possible modes from the combination will be listed and a code will be allocated to each patient, Blinding description: For the purpose of blinlding , the drug and the placebo are manufactured by the manufacturer in a way that is similar in appearance, shape, color and odor.Based on randomization of four-digit codes designed by Statistics Consultant and pasted on supplement and placebo packages.The researcher and the patient are not aware of the type of intervention. 3 Chronic Kidney Disease. Intervention 1: Intervention group: : patients in this group will receive curcumin ,500 miligram in each day, for 10 weeks. Intervention 2: Control group: : patients in this group will receive One placebo capsule in each day for 10 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 I haven't made a decision yet
public Dr Morteza Safavi
Isfahan Azadi Square, Hezar Jarib Street, Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) ۷۳۴۶۱-۸۱۷۴۶ ۳۶۶۸۰۰۴۸-۰۳۱. safavimorteza@yahoo.com Esfahan University of Medical Sciences scientific Dr.Morteza Safavi
Isfahan Azadi Square, Hezar Jarib Street, Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) ۷۳۴۶۱-۸۱۷۴۶. ۳۶۶۸۱۳۷۸-۰۳۱ safavimorteza@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) The patient's tendency to participate in study and signing approval form no use of non steroidal anti-inflammatory drugs, Nicotinic Acid, estrogen, progesterone and Curcumin supplementation for at least one month before the start of the study Lack of drug addiction Lack of severe heart disease, liver failure and thyroid diseases, severe gastrointestinal bleeding and peptic ulcer disease, cholelithiasis, pregnancy or lactation Age between 18-75 years old Stage 3:GFR:15-29 Stage 4:GFR:30-59 18 years 75 years Both kidney transplantation The use of herbal medicines as lipid lowering agents Receive omega-3 fatty acids and carnitine at least 1 month before the start of the study N25.8 Other disorders resulting from impaired renal tubular function Prevention Placebo Intervention group: : patients in this group will receive curcumin ,500 miligram in each day, for 10 weeks. Control group: : patients in this group will receive One placebo capsule in each day for 10 weeks. Blood Urea Nitrogen. Timepoint: before and after intervention. Method of measurement: Biochemistry. Serum Creatinine. Timepoint: before and after intervention. Method of measurement: Biochemistry. Serum Albumin. Timepoint: before and after intervention. Method of measurement: Biochemistry. Urine Creatinine. Timepoint: before and after intervention. Method of measurement: Biochemistry. Urine Protein. Timepoint: before and after intervention. Method of measurement: Biochemistry. Parathyroid hormone. Timepoint: before and after intervention. Method of measurement: Biochemistry. Serum Potassium. Timepoint: before and after intervention. Method of measurement: Biochemistry. High-density lipoprotein (HDL). Timepoint: before and after intervention. Method of measurement: blood sampling and direct measure. Low-density lipoprotein (LDL). Timepoint: before and after intervention. Method of measurement: blood sampling and direct measure. Triglycerid. Timepoint: before and after intervention. Method of measurement: blood sampling and direct measure. Hemocysteine. Timepoint: before and after intervention. Method of measurement: Biochemistry. Blood pressure. Timepoint: before and after intervention. Method of measurement: hypertension high blood pressure according to the millimeters Mercury with the use of digital indicator. Physical activity. Timepoint: At the beggining and end of intervention. Method of measurement: physical activity record questionnaire. Dietary intake. Timepoint: At the beggining and end of intervention. Method of measurement: 3-day food record. Body mass index (BMI). Timepoint: At the beggining and end of intervention. Method of measurement: Weight and height measurements by one person in the same center. Esfahan University of Medical Sciences Approved 2018-07-10 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Azadi Square, Isfahan Isfahan Isfehan Iran (Islamic Republic of)