End Stage Renal DiseasePhase 2NCT05822661

Impact of Black Seed Oil on Hemodialysis Patients

A Phase 2 study testing Black Seed Oil in people with End Stage Renal Disease, run by Ain Shams University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 75 years
Conditions the study is for: End Stage Renal Disease
What is being tested?: Black Seed Oil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteEgypt
Study dates: 22 Feb 2023to 23 Apr 2023
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

Egypt1 site

Ain Shams University Hospital
Cairo

Other trials in Egypt

About this study

Official title: 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.

Read the 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

Conditions: End Stage Renal Disease
Being tested: Black Seed Oil, Placebo
Keywords: black seed oil, nigella sativa, hemodialysis
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Black Seed OilDietary supplement
Also called Nigella sativa
Dietary supplement
PlaceboDietary supplement
placebo capsules same odor, color and size as the drug but without the active ingredient

Study groups in NCT05822661
Study group	Role	What they receive
Black Seed Oil	Experimental	900 mg (as two separate soft gels) twice daily for 8 weeks Receives: Dietary Supplement: Black Seed Oil
Placebo	Placebo comparator	matched placebo capsules Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

serum Endothelin-1 (ET-1) level
marker of endothelial dysfunction
Measured: 8 weeks

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Feb 202323 Apr 2023

First posted21 Apr 2023
Study start22 Feb 2023
Primary completion23 Apr 2023 (estimated)
Study completion23 Apr 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
More trials run by Ain Shams UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Drug vs placebo
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05822661
Sponsor's protocol ID: 119
Status last verified: Feb 2023
First submitted: 28 Feb 2023
Last updated: 21 Apr 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Safety and Efficacy of Empagliflozin in Hemodialysis
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A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
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All End Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Impact of Black Seed Oil on Hemodialysis Patients
ClinicalTrials.gov ID: NCT05822661
Acronym / sponsor ID: 119
Conditions: End Stage Renal Disease
Keywords: black seed oil, nigella sativa, hemodialysis
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: Ain Shams UniversityUniversity, hospital or other
Study start: 22 Feb 2023 (actual)
Primary completion: 23 Apr 2023 (estimated)
Study completion: 23 Apr 2023 (estimated)
First posted: 21 Apr 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: Drug vs placebo

Arm	Type	Receives
Black Seed Oil	Experimental	Dietary Supplement: Black Seed Oil900 mg (as two separate soft gels) twice daily for 8 weeks
Placebo	Placebo comparator	Dietary Supplement: Placebomatched placebo capsules

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Black Seed OilAlso: Nigella sativaDietary supplement	Dietary supplement	Black Seed Oil
Placeboplacebo capsules same odor, color and size as the drug but without the active ingredient	Dietary supplement	Placebo

Primary outcome

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

3 secondary outcomes

Serum malondialdehyde (MDA) and total antioxidant capacity (TAC)
Time frame: 8 weeks
Quality of life questionnaire
Time frame: 4 weeks and 8 weeks
Fatigue severity
Time frame: 4 weeks and 8 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.

Related trials for End Stage Renal Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

May A Shawki, PHD study director

Faculty of pharmacy - Ain Shams University

Areej M Ateya, PHD study director

Faculty of pharmacy - Ain Shams University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Black Seed Oil in people with End Stage Renal Disease, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

serum Endothelin-1 (ET-1) level (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05822661.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.