Objectives: According to the high prevalence of dyslipidemia and its effects on progression of chronic kidney disease and lack of research on the impact of artichokes in CKD patients, this study aimed to determine the effects of the plant on lipid profile and inflammatory factors in CKD patients.
Entry criteria: The target population in this study is adult CKD patients who were referred to Imam Khomeini hospital. The study sample included all CKD patients in 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.
Design,setting and conduct: This study is a randomized controlled clinical trial. Appropriate samples are selected by available sampling method. According to the statistics consult , sample size is 15 patients in each group, taking in to account the loss of samples 20 patients in each group have been administered as the sample size. For all samples, a full explanation is given about the objectives and methodology of research and samples enrolled after written informed consent. All samples have a questionnaire on demographic characteristics, clinical course that has been set is completed. Then the patient randomly divided in to two groups receiving either placebo or products of artichoke. Based on the random sequences produced by statistics consult, samples randomly divided in to two groups ( capsules artichoke ) and placebo ( starch capsules ). For the double-blind study , collection cans artichoke supplement or placebo by someone other than the researcher encoded so the lack of knowledge of each group for the researcher can be improvised by each group. The samples will be asked to fast in the next visit to clinic. At baseline in fasting , in all the participating patients, 5 ml venous blood is taken before the intervention and height and weight were also measured.
Intervention: In the intervention group, the samples receive artichoke capsules ( 320 mg) up to six weeks, twice daily ( 8 am and 8 pm ). In the same manner the placebo group receives placebo capsule containing starch ( 320 mg) and up to 2 weeks after the drugs have been followed. All samples in both intervention and control groups, routinely receive atorvastatin tablets. 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. Blood draw is done in the end of week 4 and 8 (after 14-12 hours of fasting )
The main outcome variables: The primary outcome is the reduction of serum LDL levels. Check triglycerides, total cholesterol, HDL, ESR, CRP and serum ferritin levels and serum iron and TIBC in the plan are secondary consequences that the change in percentage of all variables compared with the baselines determined at the week 4 and 8.