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

determination of the Effect of Nigella Sativa oil supplementation on kidney function tests, glycemic parameters, oxidative stress, inflammation, quality of life and depression status in diabetic hemodialysis patients

A clinical trial with control group, two groups of parallel, double-blind, Phase 3, on 46 hemodialysis patients, randomization using RAS software

This study will be conducted in the dialysis department of Imam Reza Hospital in Tabriz. The supplement and Placebo are produced in a completely similar way in terms of shape, color, and smell. supplements will be given to researchers and patients in a same and sealed cans. both patients and researchers are blind ton this Process.

Inclusion criteria : diabetic patients undergoing hemodialysis At least 6 months of hemodialysis his Maximum 10 years of hemodialysis history BMI between 18.5 to 30 inclusion criteria : Smoking and alcohol-abusing use of corticosteroids and NSAIDs Severe underlying diseases (stage 3 and 4 heart failure, acute liver and thyroid disease, malignancy)

The intervention group will receive 2 capsules of 1000 mg of black seed oil (with lunch and dinner). the placebo group will take 2 capsules of 1000 mg of paraffin of cellulose for 12 weeks.

Laboratory tests including: renal function tests as creatinine, urea, uric acid, urine volume indices related to blood glucose including fasting blood sugar, HbA1c, glycosylated albumin (AlGl)

In the first loading of content, a number of important and influential variables as a result of the study were mistakenly written in the secondary variables section; Therefore, in this form of correction, they were transferred to the primary variables. It was also forgotten that cholesterol and triglycerides were included in the variables, which were also included in the initial variables in their correction. Due to the fact that the nutritional status of patients could be a confounder, so the amount of energy and macronutrients consumed were included in our design as a secondary variable.

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.

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.

My protocol will be shared

beginning of 2021

Dr Ali Trighat esphanjani

Edit For analytical and epidemiological studies

email : a74.rahmani@gmail.com

sending an e-mail to : a74.rahmani@gmail.com