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IRCT20200411047027N1 IRCT 2020-05-31 Tabriz University of Medical Sciences nigella sativa in hemodialysis Effect of nigella sativa oil supplementation on kidney function tests, glycemic parameters, lipid profile, oxidative stress, inflammation, quality of life, and depression status in diabetic hemodialysis patients 2020-05-19 anticipated 46 Complete https://irct.ir/trial/48113 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients are randomly allocated to either a Nigella Sativa oil or control group by block randomization after stratification based on the frequency of hemodialysis per week (2 or 3 times per week) and the amount of blood sugar (blood glucose below 120, blood sugar between 120-200 and blood sugar above 200). This process is carried by a Statistics Specialist using RAS (Random allocation software) and in block sizes of 4. the sample size of each group is 23 people. A trained dietician will perform blinding, and the patients and researchers will be kept blinded to the allocation, Blinding description: A total of 46 ESRD patients with ESRD selected by the inclusion criteria. after explaining the objectives of the study, and obtaining written consent, they will be entered into the study. Subjects are randomly divided into two groups of intervention and control. The supplements will be available to attendees every two weeks. Each patient should consume 2 capsules daily. The supplement and Placebo are produced in a completely similar way in terms of shape, color, and smell and in sealed cans. 3 Diabetic patients undergoing hemodialysis. Intervention 1: Intervention group: The intervention group will receive 2 capsules of 1000 mg of black seed oil (with lunch and dinner) for 12 weeks. Intervention 2: Control group: the placebo group will take 2 capsules of 1000 mg of paraffin of cellulose for 12 weeks. Yes - There is a plan to make this available What will be shared: My protocol will be shared When: beginning of 2021 To whom: Dr Ali Trighat esphanjani Conditions: Edit For analytical and epidemiological studies Where to obtain: email : a74.rahmani@gmail.com How to obtain: sending an e-mail to : a74.rahmani@gmail.com Comments:
public ali tarighat esphanjani
attar ave.
tabriz Iran (Islamic Republic of) 1653666741 +98 21 7736 4020 a74.rahmani@gmail.com Tabriz University of Medical Sciences scientific ali tarighat esphanjani
attar ave
tabriz Iran (Islamic Republic of) 1653666741 +98 21 7736 4020 a74.rahmani@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Age: 18-60 BMI: 18.5-30 Diabetes At least 6 months of dialysis history maximum 10 years of dialysis history Ability and willingness to cooperate 18 years 60 years Both Background diseases (heart failure stage 3 and 4, acute liver and thyroid disease, malignancy) nigella sativa oil consumption before entering the study Alcohol addiction, smoking receiving steroidal or nonsteroidal anti-inflammatory drugs sever reaction to supplement or placebo E00–E90 Endocrine, nutritional and metabolic diseases Treatment - Drugs Treatment - Drugs Intervention group: The intervention group will receive 2 capsules of 1000 mg of black seed oil (with lunch and dinner) for 12 weeks. Control group: the placebo group will take 2 capsules of 1000 mg of paraffin of cellulose for 12 weeks Urea. Timepoint: Before baseline and after study. Method of measurement: Chemical method. Creatinine. Timepoint: Before baseline and after study. Method of measurement: jaffe method. Glycated hemoglobin (HbA1c). Timepoint: Before baseline and after study. Method of measurement: High-performance liquid chromatography (HPLC). Glycated albumin (AlGl). Timepoint: Before baseline and after study. Method of measurement: Enzymatic method. Malondialdehyde (MDA). Timepoint: Before baseline and after study. Method of measurement: Spectrophotometric method. Superoxide dismutase (SOD). Timepoint: Before baseline and after study. Method of measurement: Spectrophotometric method. Total antioxidant capacity (TAC). Timepoint: Before baseline and after study. Method of measurement: Spectrophotometric method. High-sensitivity C-reactive protein (hs-CRP). Timepoint: Before baseline and after study. Method of measurement: Turbidimetry. Urine volume. Timepoint: Before baseline and after study. Method of measurement: Through the urine within 24 hours. Insulin. Timepoint: Before baseline and after study. Method of measurement: Eliza's method. Hospital Anxiety and Depression Scale (HADS) questionnaire. Timepoint: Before baseline and after study. Method of measurement: Information on the questionnaire will be obtained from patients before and after treatment. Kidney Disease Quality of Life (KDQOL) questionnaire. Timepoint: Before baseline and after study. Method of measurement: Information on the questionnaire will be obtained from patients before and after treatment. Uric acid. Timepoint: Before baseline and after study. Method of measurement: Spectrophotometric method. High-density lipoprotein (HDL). Timepoint: Before baseline and after study. Method of measurement: Spectrophotometric method. Low-density lipoprotein (LDL). Timepoint: Before baseline and after study. Method of measurement: Spectrophotometric method. Energy consumption. Timepoint: Before starting the study. Method of measurement: 24-h Questionnaire. Macronutrient consumption. Timepoint: Before starting the study. Method of measurement: 24-h Questionnaire. Tabriz University of Medical Sciences Approved 2020-05-04 Ethics committee of tabriz University of Medical Sciences attar ave tabriz East Azarbaijan Iran (Islamic Republic of)