Impact of Black Seed Oil on Hemodialysis Patients

April 8, 2023 updated by: Ain Shams University

Evaluation of the Impact of Black Seed Oil on Hemodialysis Patients

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Black Seed Oil
900 mg (as two separate soft gels) twice daily for 8 weeks
Dietary supplement: Black Seed Oil
Dietary supplement
Other Names:
  • Nigella sativa
Placebo Comparator: Placebo
matched placebo capsules
Dietary supplement: Placebo
placebo capsules same odor, color and size as the drug but without the active ingredient

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: May A Shawki, PHD, Faculty of pharmacy - Ain Shams University
  • Study Director: Areej M Ateya, PHD, Faculty of pharmacy - Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2023

Primary Completion (Anticipated)

April 23, 2023

Study Completion (Anticipated)

April 23, 2023

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

April 8, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 119 (hhh)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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