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NCT05822661 Clinical Trial

Impact of Black Seed Oil on Hemodialysis Patients

End Stage Renal Disease Clinical Trial

Official title:
Evaluation of the Impact of Black Seed Oil on Hemodialysis Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05822661
Other study ID # 119
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date February 22, 2023
Est. completion date April 23, 2023

Study information
Verified date February 2023
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date April 23, 2023
Est. primary completion date April 23, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Black Seed Oil
Dietary supplement
• Placebo
placebo capsules same odor, color and size as the drug but without the active ingredient

Locations
Country Name City State
Egypt Ain Shams University Hospital Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary serum Endothelin-1 (ET-1) level marker of endothelial dysfunction 8 weeks
Secondary Serum malondialdehyde (MDA) and total antioxidant capacity (TAC) markers of oxidative stress 8 weeks
Secondary Quality of life questionnaire using validated Arabic version SF-36 questionnaire 4 weeks and 8 weeks
Secondary Fatigue severity using the Multidimensional Fatigue Inventory (MFI) 4 weeks and 8 weeks
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