Impact of Black Seed Oil on Hemodialysis Patients

Evaluation of the Impact of Black Seed Oil on Hemodialysis Patients

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05822661

Enrollment

Registered

2023-04-21

Start date

2023-02-22

Completion date

2023-04-23

Last updated

2023-04-21

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

Conditions

End Stage Renal Disease

Keywords

black seed oil, nigella sativa, hemodialysis

Brief summary

The aim of the study is to evaluate the effect of black seed oil on endothelial dysfunction, oxidative stress and quality of life in hemodialysis patients.

Detailed description

Evaluation of the effect of black seed oil in hemodialysis patients via: * Evaluation of serum Endothelin-1 levels * Evaluation of serum Malondialdehyde (MDA) levels * Evaluation of serum Total Antioxidant Capacity (TAC) levels * Evaluation of Quality of Life (QOL) * Evaluation of fatigue scale

Interventions

DIETARY_SUPPLEMENTBlack Seed Oil

Dietary supplement

DIETARY_SUPPLEMENTPlacebo

placebo capsules same odor, color and size as the drug but without the active ingredient

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Drug vs placebo

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Age ≥ 20 years old * Three to four times per week hemodialysis * Being on hemodialysis for at least 6 months * Ability and willingness to cooperate in the study

Exclusion criteria

* Pregnancy or lactation * Cigarette smoking or substance/alcohol abuse * Having active infectious diseases * Receiving steroidal or nonsteroidal anti-inflammatory drugs * Using Nigella sativa oil regularly * Changes in treatment methods (dialysis) or medications during the supplementation

Design outcomes

Primary

Measure	Time frame	Description
serum Endothelin-1 (ET-1) level	8 weeks	marker of endothelial dysfunction

Secondary

Measure	Time frame	Description
Fatigue severity	4 weeks and 8 weeks	using the Multidimensional Fatigue Inventory (MFI)
Serum malondialdehyde (MDA) and total antioxidant capacity (TAC)	8 weeks	markers of oxidative stress
Quality of life questionnaire	4 weeks and 8 weeks	using validated Arabic version SF-36 questionnaire

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026