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IRCT20210825052286N1 IRCT 2021-10-17 Esfahan University of Medical Sciences Effect of garlic supplementation pill in dialyisic patient Evaluation effect of garlic supplementation pill on dialysis adequacy , serum albumin, PTH, calcium, phosphorus, CRP levels and blood lipid profile in patients undergoing chronic hemodialysis in Khorshid and amin hospital (Esfahan)2020-2021 2021-11-22 anticipated 88 Complete https://irct.ir/trial/58353 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After collecting all the subjects (88 patients), they are divided into two groups of intervention (44 patients) and control (44 patients) by simple individual randomization using statistical software.In this process participants, researchers and questioners, sample takers and registrants, data importers and data analysts, as well as the Data Monitoring and Safety Committee are unaware of the type of this allocation, Blinding description: In the assignment stage : All subjects are divided into two intervention and control groups of 44 people without any knowledge in terms of allocation as well as questioners. In the blood sampling stage at pre- and post-intervention phase, the participant ,samplers, laboratory staff, questioners, and registrants of the results are not aware of the participants' assigned group. In the intervention stage: the intervention group is given a garlic supplement that is odorless and the control group is given control of placebo tablets containing starch that are odorless and have the same appearance as garlic tablets (from the same company). In the stage of data collection and analysis: Questioners, data importers and analysts do not know the type of intervention and control group and the data is given to them in form of group 1 and group 2. 3 Chronic Kidney Disease. Intervention 1: Intervention group: Garlic pill made by Gol Daroo Pharmaceutical Company, which is odorless and contains 500 mg of garlic t and 2 mg of allicin, two pills daily after lunch. Intervention 2: Control group: Placebo tablets of Gol Daroo Pharmaceutical Company that contain starch and they are odorless and have the same appearance as garlic pills, two pills daily after lunch. 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 This study hasn't started yet and if the participants agree the data will be published
public Farzaneh Fatahi
No. 100, Farshadi Ave,Chahar Bagh Bala Ave
Esfahan Iran (Islamic Republic of) 8175963681 +98 31 3625 6177 drfatahi79@gmail.com Esfahan University of Medical Sciences scientific Farzaneh Fatahi
NO. 100,Farshadi Ave,Chahar Bagh Bala Ave
Esfahan Iran (Islamic Republic of) 8175963681 +98 31 3625 6177 drfatahi79@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Chronic kidney Patients that undergoing hemodialysis for at least three months 18 years no limit Both Patients receiving warfarin, clopidogrel Being pregnant N18 Chronic kidney disease (CKD) Treatment - Drugs Placebo Intervention group: Garlic pill made by Gol Daroo Pharmaceutical Company, which is odorless and contains 500 mg of garlic t and 2 mg of allicin, two pills daily after lunch. Control group: Placebo tablets of Gol Daroo Pharmaceutical Company that contain starch and they are odorless and have the same appearance as garlic pills, two pills daily after lunch Serum albumin. Timepoint: before intervention and 8 weeks after intervention starts. Method of measurement: Blood sampling for serum albumin. Serum PTH(Para Thyroid Hormone). Timepoint: Before intervention and 8 weeks after intervention starts. Method of measurement: blood sampling for serum PTH. Serum calcium. Timepoint: Before intervention and 8 weeks after intervention starts. Method of measurement: Blood sampling for serum calcium. Serum phosphorus. Timepoint: Before intervention and 8 weeks after intervention starts. Method of measurement: Blood sampling for serum phosphorus. Serum CRP(C-Reactive Peptide). Timepoint: Before intervention and 8 weeks after intervention starts. Method of measurement: Blood sampling for serum CRP(C-Reactive Peptide). Serum total cholesterol. Timepoint: Before intervention and 8 weeks after intervention starts. Method of measurement: Blood sampling for serum total cholesterol. Serum Low Density Lipoprotein (LDL). Timepoint: Before intervention and 8 weeks after intervention starts. Method of measurement: Blood sampling for serum Low Density Lipoprotein (LDL). Serum High Density Lipoprotein (HDL). Timepoint: Before intervention and 8 weeks after intervention starts. Method of measurement: Blood sampling for serum High Density Lipoprotein (HDL). Serum triglyceride. Timepoint: Before intervention and 8 weeks after intervention starts. Method of measurement: Blood sampling for serum triglyceride. Esfahan University of Medical Sciences Approved 2021-07-16 Ethics committee of Esfahan University of Medical Sciences Esfahan University of Medical Sciences, Hezar Jerib Street Esfahan Isfehan Iran (Islamic Republic of)