Impact of Black Seed Oil on Hemodialysis Patients

Phase 2

Active, not recruiting

• Conditions: End Stage Renal Disease
• Interventions: Dietary Supplement: Black Seed Oil; Dietary Supplement: Placebo

• Registration Number: NCT05822661
• Lead Sponsor: Ain Shams University

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

Study Timeline

• Status Verified: 2023-02
• Study Start: 2023-02-22
• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-04-08
• Last Update Submitted: 2023-04-08
• Study First Posted: 2023-04-21
• Last Update Posted: 2023-04-21
• Primary Completion: 2023-04-23
• Study Completion: 2023-04-23

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Black Seed Oil	Black Seed Oil	900 mg (as two separate soft gels) twice daily for 8 weeks
Placebo	Placebo	matched placebo capsules

Primary Outcome Measures

Name	Time	Method
serum Endothelin-1 (ET-1) level	8 weeks	marker of endothelial dysfunction

Secondary Outcome Measures

Name	Time	Method
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
Fatigue severity	4 weeks and 8 weeks	using the Multidimensional Fatigue Inventory (MFI)

Trial Locations

Locations (1)

Ain Shams University Hospital; 🇪🇬 Cairo, Egypt