Impact of Black Seed Oil on Hemodialysis Patients

Sponsor

Ain Shams University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05822661

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

30.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease	Dietary Supplement: Black Seed Oil Dietary Supplement: Placebo	Phase 2

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

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Drug vs placeboDrug vs placebo

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Evaluation of the Impact of Black Seed Oil on Hemodialysis Patients

Actual Study Start Date :

Feb 22, 2023

Anticipated Primary Completion Date :

Apr 23, 2023

Anticipated Study Completion Date :

Apr 23, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

serum Endothelin-1 (ET-1) level [8 weeks]
marker of endothelial dysfunction

Secondary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University Hospital	Cairo		Egypt

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ain Shams University

ClinicalTrials.gov Identifier:

NCT05822661

Other Study ID Numbers:

First Posted:

Apr 21, 2023

Last Update Posted:

Apr 21, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ain Shams University

black seed oil

nigella sativa

hemodialysis

Additional relevant MeSH terms:

Kidney Failure, Chronic

Study Results

No Results Posted as of Apr 21, 2023