Impact of Black Seed Oil on Hemodialysis Patients

NCT ID: NCT05822661

Last Updated: 2023-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-22

Study Completion Date

2023-04-23

Brief Summary

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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

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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

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End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Drug vs placebo
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Black Seed Oil

900 mg (as two separate soft gels) twice daily for 8 weeks

Group Type EXPERIMENTAL

Black Seed Oil

Intervention Type DIETARY_SUPPLEMENT

Dietary supplement

Placebo

matched placebo capsules

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Black Seed Oil

Dietary supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Nigella sativa

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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May A Shawki, PHD

Role: STUDY_DIRECTOR

Faculty of pharmacy - Ain Shams University

Areej M Ateya, PHD

Role: STUDY_DIRECTOR

Faculty of pharmacy - Ain Shams University

Locations

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Ain Shams University Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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119

Identifier Type: -

Identifier Source: org_study_id

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