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Impact of Black Seed Oil on Hemodialysis Patients

Primary Purpose

End Stage Renal Disease

Status
Active
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Black Seed Oil
Placebo
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring black seed oil, nigella sativa, hemodialysis

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ain Shams University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Black Seed Oil

Placebo

Arm Description

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

matched placebo capsules

Outcomes

Primary Outcome Measures

serum Endothelin-1 (ET-1) level
marker of endothelial dysfunction

Secondary Outcome Measures

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

Full Information

First Posted
February 28, 2023
Last Updated
April 8, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05822661
Brief Title
Impact of Black Seed Oil on Hemodialysis Patients
Official Title
Evaluation of the Impact of Black Seed Oil on Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
April 23, 2023 (Anticipated)
Study Completion Date
April 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
black seed oil, nigella sativa, hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Drug vs placebo
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Black Seed Oil
Arm Type
Experimental
Arm Description
900 mg (as two separate soft gels) twice daily for 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
matched placebo capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Black Seed Oil
Other Intervention Name(s)
Nigella sativa
Intervention Description
Dietary supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
placebo capsules same odor, color and size as the drug but without the active ingredient
Primary Outcome Measure Information:
Title
serum Endothelin-1 (ET-1) level
Description
marker of endothelial dysfunction
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Serum malondialdehyde (MDA) and total antioxidant capacity (TAC)
Description
markers of oxidative stress
Time Frame
8 weeks
Title
Quality of life questionnaire
Description
using validated Arabic version SF-36 questionnaire
Time Frame
4 weeks and 8 weeks
Title
Fatigue severity
Description
using the Multidimensional Fatigue Inventory (MFI)
Time Frame
4 weeks and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
May A Shawki, PHD
Organizational Affiliation
Faculty of pharmacy - Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Areej M Ateya, PHD
Organizational Affiliation
Faculty of pharmacy - Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams University Hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

Impact of Black Seed Oil on Hemodialysis Patients

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