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IRCT2016021622689N3 IRCT 2016-06-18 Vice chancellor for research and technology, Tehran university of medical sciences The effect of Cynara Scolymus on hyperlipidemia To determine the effectiveness of Cynara Scolymus extract on lipid profile of patients with chronic kidney disease compared with placebo 2016-03-20 anticipated 40 Complete https://irct.ir/trial/19516 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 Chronic kidney disease. Intervention 1: In the intervention group, the samples receive artichoke capsules ( 320 mg) up to 6 weeks twice daily ( 8 am and 8 pm ). All samples in both intervention and control groups, routinely receive atorvastatin tablets and low salt diet. The samples will be asked not to change in their diet and physical activity during this study and inform researchers about any changes in their medications. Intervention 2: In the placebo group, the samples receive placebo capsule containing starch ( 320 mg) up to 6 weeks twice daily ( 8 am and 8 pm ). All samples in both intervention and control groups, routinely receive atorvastatin tablets and low salt diet. The samples will be asked not to change in their diet and physical activity during this study and inform researchers about any changes in their medications.
public Ebrahim Khadem
Vice chancellor for student in Tehran university of medical science , building 43 , No. 21 , Fardanesh Alley , Ghods street , Keshavarz boulevard
Tehran Iran (Islamic Republic of) 1417733161 +98 21 8897 4638 Dr.Ebrahimkhadem@yahoo.com School of traditional medicine Tehran university of medical sciences ,Vice chancellor for student in scientific Seyyed mansour Gatmiri
Nephrology research center , Imam Khomeini hospital complex , the end of Keshavarz blvd.
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2679 gatmiri@tums.ac.ir Tehran university of medical science ,Imam Khomeini hospital Iran (Islamic Republic of) Entry criteria:Patients with chronic kidney disease, stage 3 (GFR: 30-59 mL/min/1.73m2); stage 4 (GFR: 15-29 mL/min/1.73m2); stage 5 (GFR< 15 ml/min/1.73 m 2 ); with failure to control blood lipids (serum LDL ≥110 mg/dl & cholestrol ≥ 200); without exclusion criteria; also willing to participate in the study; and at least 4 months before the start of the study have received low-fat diet and statin drugs; having a case in considered nephrology center; The willingness of patients to participate in research ٍٍExclusion criteria: History of biliary obstructive disorders and gallstones; Artichoke use at least one month before the start of the study; unwillingness to continue to cooperate or traveling or death; pregnancy and lactation; the development of side effects of drug; lack of medication over a week. 18 years 70 years Both N18.5 ,N18 Kidney damage with moderately decreased GFR (30-59 mL/min) ; Kidney damage with severely decreased GFR (15-29 mL/min) ; Chronic uraemia End stage kidney disease: in allograft failure NOS on dialysis or without dialysis or transplant , Renal retinitis , Treatment - Drugs Treatment - Drugs In the intervention group, the samples receive artichoke capsules ( 320 mg) up to 6 weeks twice daily ( 8 am and 8 pm ). All samples in both intervention and control groups, routinely receive atorvastatin tablets and low salt diet. The samples will be asked not to change in their diet and physical activity during this study and inform researchers about any changes in their medications. In the placebo group, the samples receive placebo capsule containing starch ( 320 mg) up to 6 weeks twice daily ( 8 am and 8 pm ). All samples in both intervention and control groups, routinely receive atorvastatin tablets and low salt diet. The samples will be asked not to change in their diet and physical activity during this study and inform researchers about any changes in their medications. Serum LDL concentration. Timepoint: At baseline and at the end of 4 and 8 weeks of study. Method of measurement: Special kits. Serum triglyceride concentrations. Timepoint: At baseline and at the end of 4 and 8 weeks of study. Method of measurement: Special kits. Serum HDL concentrations. Timepoint: At baseline and at the end of 4 and 8 weeks of study. Method of measurement: special kits. Serum cholestrol concentrations. Timepoint: At baseline and at the end of 4 and 8 weeks of study. Method of measurement: special kits. Serum CRP concentrations. Timepoint: At baseline and at the end of 4 and 8 weeks of study. Method of measurement: special kits. Serum ESR concentrations. Timepoint: At baseline and at the end of 4 and 8 weeks of study. Method of measurement: special kits. Serum ferritin concentrations. Timepoint: At baseline and at the end of 4 and 8 weeks of study. Method of measurement: special kits. Serum iron concentrations. Timepoint: At baseline and at the end of 4 and 8 weeks of study. Method of measurement: special kits. Serum TIBC concentrations. Timepoint: At baseline and at the end of 4 and 8 weeks of study. Method of measurement: special kits. Vice chancellor for research and technology, Tehran university of medical sciences Approved 2016-01-02 The ethics committee of Tehran university of medical sciences Sixth floor, , central building of the Tehran university of medical sciences , Ghods street , Keshavarz blvd Tehran Iran (Islamic Republic of)