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Protocol summary

Study aim
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
Design
A randomized double-blind clinical trial with two-arm parallel groups phase 3 trial with 46 sample size
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
serum level of ICAM and VCAM lipidemic and glycemic indices oxidative parameters

General information

Reason for update
End of the sampling
Acronym
IRCT registration information
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
Registration date
2019-11-08, 1398/08/17
Registrant information
Name
Omid Mohammad Tavakoli Rouzabehani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 7581
Email address
omidmtr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
2019-11-28, 1398/09/07
Actual recruitment end date
2020-02-29, 1398/12/10
Trial completion date
2020-03-02, 1398/12/12
Scientific title
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
Public title
Nigella sativa in coronary artery disease
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 35 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 46
Actual sample size reached: 43
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Attar Neyshabouri Av., Golgasht St.
City
tabriz
Province
East Azarbaijan
Postal code
5166/15731
Approval date
2019-10-14, 1398/07/22
Ethics committee reference number
IR.TBZMED.REC.1398.687

Health conditions studied

1

Description of health condition studied
coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery

Primary outcomes

1

Description
ICAM serum level
Timepoint
baseline and 8 week after intervention
Method of measurement
measurement via ELISA kit

2

Description
VCAM serum level
Timepoint
baseline and 8 week after intervention
Method of measurement
measurement via ELISA kit

3

Description
Lipid profile including HDL, LDL, TC and TG
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
HDL, TC and TG via enzymatic kit, LDL via friedewald equation

4

Description
Oxidative stress indices
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Measurement of serum levels of Total antioxidant capacity (TAC) and malondialdehyde (MDA) and Superoxide dismutase by spectrophotometry

5

Description
glycemic indices including FBS, HbA1C, insulin, HOMA-IR
Timepoint
before and after the 8 weeks supplementation
Method of measurement
Elisa and spectrometer

Secondary outcomes

1

Description
depression severity
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Beck Depression Inventory scale

2

Description
Physical activity level
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Via IPAQ questionnaire

3

Description
Quality of life
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Via MacNew questionnaire

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
Control group: Patients in this group will receive avicel capsules for 8 weeks which are same size and shape, and used once a day.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Madani Medical Research Training Center
Full name of responsible person
Dr mohammad alizadeh
Street address
Daneshgah street, Shahid Madani Medical Research Training Center
City
tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Fax
+98 41 3334 0634
Email
mdalizadeh@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr juyban
Street address
Vice Chancellor for Research No 2 Central Building, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz
City
tabrzi
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Email
mdalizadeh@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
omid mohammad tavakoli rouzbehani
Position
Msc student of clinical nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golgasht street, Tabriz university of medical sciences
City
tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3381 1902
Fax
+98 41 3334 0634
Email
omidmtr@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr mohammad alizadeh
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht street, Tabriz university of medical sciences
City
tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Email
mdalizadeh@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr mohammad alizadeh
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht street, Tabriz university of medical sciences
City
tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1335 7313
Fax
+98 41 1334 4731
Email
mdalizadeh@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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