Impact of Black Seed Oil on Hemodialysis Patients | NCT05822661

Studies
Impact of Black Seed Oil on Hemodialysis Patients

NCT05822661

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Apr 21, 2023Actual

Enrollment

60Estimated

Phase

Phase 2

Conditions

End Stage Renal Disease

Interventions

Black Seed Oil
Placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 22, 2023Actual

Primary Completion Date

Apr 23, 2023Estimated

Completion Date

Apr 23, 2023Estimated

First Submitted Date

Feb 28, 2023

First Submission Date that Met QC Criteria

Apr 8, 2023

First Posted Date

Apr 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2023

Last Update Posted Date

Apr 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Black Seed Oil	Experimental	900 mg (as two separate soft gels) twice daily for 8 weeks	Dietary Supplement: Black Seed Oil
Placebo	Placebo Comparator	matched placebo capsules	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Black Seed Oil	Dietary Supplement	Dietary supplement	Black Seed Oil

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Serum malondialdehyde (MDA) and total antioxidant capacity (TAC)	markers of oxidative stress	8 weeks
Quality of life questionnaire	using validated Arabic version SF-36 questionnaire

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
May A Shawki, PHD	Faculty of pharmacy - Ain Shams University	Study Director
Areej M Ateya, PHD	Faculty of pharmacy - Ain Shams University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams University Hospital		Cairo			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000723271	Nigella sativa oil

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided