The effects of Nigella sativa oil supplement on serum systemic inflammatory and oxidative stress markers and lipid profiles in dialysis patients: double-blind clinical trial
Investigate the effects of Nigella sativa oil supplement on inflammatory serum systemic and oxidative stress markers and lipid profiles in hemodialysis patients.
Design
A clinical trial with a control group, with parallel groups, double-blind, phase 3 was performed on 50 hemodialysis patients.
Settings and conduct
Patients referred to the dialysis ward of Sabzevar Vasei Hospital with inclusion criteria were divided into two groups. All capsules ( Nigella sativa and placebo) had similar appearance.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The study subjects were being dialyzed with polysulfone capillary dialyzers 3 times a week for 4 h per session
The study, the hemodialysis procedure and type of dialyzer were not altered
Must be able to swallow capsules
Exclusion criteria: infectious diseases especially hepatitis, patients taking Nigella sativa oil, , patients taking omega-3 fatty acid supplements, L-carnitine, patients taking vitamin E and/or C supplements, patients taking steroidal and/or non-steroidal anti-inflammatory drugs
Intervention groups
Subjects in the intervention group received 2 capsules were prepared by Barij Essence Kashan Company (1000 mg Nigella sativa oil) daily for 8 weeks. whereas the placebo group received 2 placebo capsules containing medium-chain triglyceride oils were prepared by Barij Essence Kashan Company
The effects of Nigella sativa oil supplement on serum systemic inflammatory and oxidative stress markers and lipid profiles in dialysis patients: double-blind clinical trial
Public title
The effect of black seed oil in dialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The study subjects were being dialyzed with polysulfone capillary dialyzers 3 times a week for 4 h per session
The study, the hemodialysis procedure and type of dialyzer were not altered
Must be able to swallow capsules
Exclusion criteria:
infectious diseases especially hepatitis
patients taking Nigella sativa
patients taking omega-3 fatty acid supplements, L-carnitine
patients taking vitamin E and/or C supplements
patients taking steroidal and/or non-steroidal anti-inflammatory drugs.
Age
From 45 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
55
More than 1 sample in each individual
Number of samples in each individual:
2
At the begining and the end of week 8, 5 ml blood was collected from each patient after a 12 hour fast before hemodialysis
Actual sample size reached:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In the present study, participants and researchers during the study did not know whether each individual would be in the intervention or control group. For blinding, ginger and placebo capsules will be similar in appearance, packaging and labeling. For this double blind study, at the start of the study, a set of bottles containing capsule is encoded A and B, by a person other than the researcher so that the researcher is not aware of the type of capsules received by each group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical sciences, Shohadaye Hastehei Blvd, Sabzevar, Iran
The serum hs-CRP concentration was determined using enzyme linked immune sorbent assay, the serum malondialdehyde (MDA) concentration was assessed using commercial colorimetric kits, the serum lipids was measured auto-analyzer with Pars Azmoon kits
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 2 capsules containing 1000 mg of Nigella sativa oil made by Kashan Barij Essential Oil Company were given to the research units daily for 8 weeks.
Category
Placebo
2
Description
Control group: 2 capsules containing medium-chain triglyceride oils made by Kashan Barij Essential Oil Company were given to the research units daily for 8 weeks.