Impact of Black Seed Oil on Hemodialysis Patients

Ain Shams University

Status and phase: Active, not recruiting; Phase 2

Conditions: End Stage Renal Disease

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Black Seed Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT05822661

119

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Black Seed Oil

Experimental group

Description:

900 mg (as two separate soft gels) twice daily for 8 weeks

Treatment:

Dietary Supplement: Black Seed Oil

Placebo

Placebo Comparator group

Description:

matched placebo capsules

Treatment:

Dietary Supplement: Placebo