Protocol summary
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Study aim
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The effect of supplementation of Nigella Sativa oil extract on plasma level of ICAM-1, VCAM-1, metabolic, oxidative and nutritional status in patients with coronary artery disease
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Design
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A randomized double-blind clinical trial with two-arm parallel groups phase 3 trial with 46 sample size
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Settings and conduct
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The trial will be conducted at outpatient cardiology clinic of Shahid Madani Heart center affiliated to Tabriz University of Medical Sciences, Iran. All the patients will be screened by an expert cardiologist for eligibility. Those willing to take part in the study will be carefully evaluated with reference to inclusion criteria. Then, they will be requested to sign an informed consent. A third party who is blind to the study will give the sequence extracted from allocation software. After an overnight fasting, blood will be collected and supplements will be provided to the participants. supplementation duration will be 8 weeks.
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Participants/Inclusion and exclusion criteria
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inclusion criteria: age between 30-65 years, BMI between 25 -45, Proof of 50% stenosis in at least one of the major coronary arteries in angiography, Ability, and willingness to collaborate on the project
exclusion criteria: pregnancy or lactation, smoking cigaret or opiates, any background chronic disease
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Intervention groups
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Intervention group: Patients in this group will receive Nigella sativa soft gel capsule for 8 weeks. Nigella sativa soft gel is a containing 1 gram of Nigella sativa oil and used twice a day.
Control group: Patients in this group will receive avicel capsules for 8 weeks which are same size and shape, and used once a day.
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Main outcome variables
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serum level of ICAM and VCAM
lipidemic and glycemic indices
oxidative parameters
General information
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Reason for update
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End of the sampling
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190506043494N1
Registration date:
2019-11-08, 1398/08/17
Registration timing:
prospective
Last update:
2020-05-21, 1399/03/01
Update count:
1
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Registration date
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2019-11-08, 1398/08/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-11-22, 1398/09/01
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Expected recruitment end date
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2020-02-20, 1398/12/01
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Actual recruitment start date
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2019-11-28, 1398/09/07
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Actual recruitment end date
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2020-02-29, 1398/12/10
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Trial completion date
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2020-03-02, 1398/12/12
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Scientific title
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The effects of nigella sativa extract oil supplementation on plasma level of ICAM-1, VCAM-1 , metabolic and oxidative parameters and nutritional status in paients with coronary artery disease
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Public title
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Nigella sativa in coronary artery disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
age between 35-65 years
BMI between 25 -45
Proof of 50% stenosis in at least one of the major coronary arteries in angiography
Ability and willingness to collaborate on the project
Exclusion criteria:
Any cardiovascular , kidney and chronic diseases
consumption of herbal or nutritional supplements in the last 1-2 months
heart failure function class 3 , 4
use of medicine or surgery for weight loss
Use of cigarettes, alcohol and drugs
pregnancy or lactation
taking niacin and fibrates
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Age
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From 35 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
46
Actual sample size reached:
43
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The eligible participants will be randomly allocated to intervention and placebo groups using a software-generated random permuted blocks. The generated random sequence will be kept in a protected location and administered by an independent third party who is blind to the trial throughout the study.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this double-blind study, no patient and investigator will be aware of the treatment assignments for the duration of the study. For blinding the trial, the Nigella sativa capsules and placebo, will be identical in appearance, packaging, and labeling. All capsules will be packed and encoded by the company
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-10-14, 1398/07/22
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Ethics committee reference number
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IR.TBZMED.REC.1398.687
Health conditions studied
1
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Description of health condition studied
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coronary artery disease
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ICD-10 code
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I25.1
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ICD-10 code description
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Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
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Description
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ICAM serum level
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Timepoint
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baseline and 8 week after intervention
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Method of measurement
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measurement via ELISA kit
2
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Description
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VCAM serum level
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Timepoint
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baseline and 8 week after intervention
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Method of measurement
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measurement via ELISA kit
3
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Description
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Lipid profile including HDL, LDL, TC and TG
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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HDL, TC and TG via enzymatic kit, LDL via friedewald equation
4
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Description
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Oxidative stress indices
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Timepoint
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Baseline and 12 weeks after intervention
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Method of measurement
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Measurement of serum levels of Total antioxidant capacity (TAC) and malondialdehyde (MDA) and Superoxide dismutase by spectrophotometry
5
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Description
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glycemic indices including FBS, HbA1C, insulin, HOMA-IR
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Timepoint
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before and after the 8 weeks supplementation
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Method of measurement
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Elisa and spectrometer
Secondary outcomes
1
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Description
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depression severity
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Beck Depression Inventory scale
2
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Description
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Physical activity level
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Via IPAQ questionnaire
3
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Description
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Quality of life
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Via MacNew questionnaire
Intervention groups
1
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Description
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Intervention group: Patients in this group will receive Nigella sativa soft gel capsule for 8 weeks. Nigella sativa soft gel is a containing 1 gram of Nigella sativa oil and used twice a day.
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients in this group will receive avicel capsules for 8 weeks which are same size and shape, and used once a day.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available