NCT05822661

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2023

Completed
Last Updated

April 21, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

February 28, 2023

Last Update Submit

April 8, 2023

Conditions

End Stage Renal Disease

Keywords

black seed oilnigella sativahemodialysis

Outcome Measures

Primary Outcomes (1)

  • serum Endothelin-1 (ET-1) level

    marker of endothelial dysfunction

    8 weeks

Secondary Outcomes (3)

  • Serum malondialdehyde (MDA) and total antioxidant capacity (TAC)

    8 weeks

  • Quality of life questionnaire

    4 weeks and 8 weeks

  • Fatigue severity

    4 weeks and 8 weeks

Study Arms (2)

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

Black Seed OilDIETARY_SUPPLEMENT

Dietary supplement

Also known as: Nigella sativa
Black Seed Oil
PlaceboDIETARY_SUPPLEMENT

placebo capsules same odor, color and size as the drug but without the active ingredient

Placebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Nigella sativa oil

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • May A Shawki, PHD

    Faculty of pharmacy - Ain Shams University

    STUDY DIRECTOR

  • Areej M Ateya, PHD

    Faculty of pharmacy - Ain Shams University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Drug vs placebo
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2023

First Posted

April 21, 2023

Study Start

February 22, 2023

Primary Completion

April 23, 2023

Study Completion

April 23, 2023

Last Updated

April 21, 2023

Record last verified: 2023-02

Locations

EG(1)