Study Results
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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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2023-02-22
2023-04-23
Brief Summary
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Detailed Description
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* 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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Black Seed Oil
900 mg (as two separate soft gels) twice daily for 8 weeks
Black Seed Oil
Dietary supplement
Placebo
matched placebo capsules
Placebo
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
Placebo
placebo capsules same odor, color and size as the drug but without the active ingredient
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
75 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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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
Countries
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Other Identifiers
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119
Identifier Type: -
Identifier Source: org_study_id
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