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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200411047027N1

Enrollment

Registered

2020-05-31

Start date

2020-05-19

Completion date

Unknown

Last updated

2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic patients undergoing hemodialysis. Endocrine, nutritional and metabolic diseases

Interventions

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 w

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public Contactali tarighat esphanjani

Tabriz University of Medical Sciences

a74.rahmani@gmail.com+98 21 7736 4020

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026