The present study aims to evaluate the efficacy of treatment with an oral Nigella sativa (NS) seed oil in hypertensive patients. Subjects will be informed that they may take NS oil or placebo in the informed consent. Therefore, patients aren't aware of their therapeutic group they will be assigned. In addition, neither patients nor medical staff will be aware of the type of oils in the container (Ns oil or placebo). Only the researcher is aware of the code written on the container of the oils; so, this study is a double-blind, parallel clinical trial. Hypertensive patients with SBP /DBP ≥ 140/90 mmHg were eligible for inclusion. Patients who smoke and patients who consume antioxidant products aren't enrolled in the study. One hundred of patients attending the Quaem outpatient’s clinic who meet our inclusion criteria will take part in this study. By using random numbers (created by computer) subjects will randomly allocate to one of two experimental groups: a placebo and a test group. Thus, 50 cases in each treatment arm receive placebo or NS oil. In the intervention group, 5 ml oral NS oil is administered daily for 8 weeks. Patients in the control group receive placebo in the same way. Systolic and diastolic pressure (during intervention) and serum Malondialdehyde [MDA] (before and 8 weeks after intervention) will be checked as primary outcomes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013082614477N1
Registration date:2013-10-03, 1392/07/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-10-03, 1392/07/11
Registrant information
Name
Zhila Taherzadeh
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 3255
Email address
taherzadehzh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad university of medical sciences
Expected recruitment start date
2013-11-21, 1392/08/30
Expected recruitment end date
2017-01-01, 1395/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Nigella sativa seed oil compared with placebo on blood pressure in hypertensive patients
Public title
Effect of Nigella sativa seed oil in treatment of hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Hypertensive patients with SBP/DBP ≥ 140/90 mmHg who do not suffer from heart, kidney and liver failure were eligible for inclusion.
Exclusion criteria: Patients who smoke and patients who consume antioxidant products aren't enrolled in the study.
Age
From 45 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Regional Committee for Research Ethics, Mashhad University of Medical Sciences
Street address
Ghoreishi building, Daneshgah Street
City
Mashhad
Postal code
91375-345
Approval date
2013-06-08, 1392/03/18
Ethics committee reference number
92/191552
Health conditions studied
1
Description of health condition studied
Hypertensive patients
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Diastolic Blood pressure
Timepoint
During the intervention (every week)
Method of measurement
blood pressure manometer
2
Description
Systolic Blood pressure
Timepoint
During the intervention (every week)
Method of measurement
blood pressure manometer
3
Description
Malondialdehyde [MDA] in serum
Timepoint
Before and 8 weeks after intervention
Method of measurement
Spectrophotometry
Secondary outcomes
1
Description
Blood sugar
Timepoint
Before and 8 weeks after the intervention
Method of measurement
Biochemical test
2
Description
Lipid profile
Timepoint
Before and 8 weeks after the intervention
Method of measurement
Biochemical test
Intervention groups
1
Description
The patients in Intervention group will orally receive 5 ml /day of Nigella Sativa seed oil for 8 weeks in addition to their current treatment regimen.
Category
Treatment - Drugs
2
Description
Control group will orally receive 5 ml /day of Sunflower seed oil for 8 weeks in addition to their current treatment regimen. Sunflower seed oil, which is used as a placebo, has no real effect on blood pressure. This oil has very similar physical characteristics to NS oil. Only the code written on the containers are different from each other. Frequency and duration of using placebo oil in the control group are absolutely the same as NS oil in the intervention group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Quaem Hospital
Full name of responsible person
Zhila Taherzadeh
Street address
School of pharmacy, Pardis university campus, Park square
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad university of medical sciences
Full name of responsible person
Dr. Mohsen Tafaghodi (Research Deputy of Mashhad University of Medical Sciences)
Street address
School of pharmacy, Pardis university campus, Park square
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zamanzadeh Mansoureh
Position
Pharmacy student
Other areas of specialty/work
Street address
School of pharmacy, Pardis university campus, Park square
City
Mashhad
Postal code
91775-1365
Phone
+98 51 1882 3255
Fax
+98 51 1882 3251
Email
Zamanzadehm861@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zhila Taherzadeh
Position
Ph.D
Other areas of specialty/work
Street address
School of pharmacy, Pardis university campus, Park square
City
Mashhad
Postal code
91775-1365
Phone
+98 51 1882 3255
Fax
+98 51 1882 3251
Email
Taherzadehzh@mums.ac.ir; Eslamia@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zamanzadeh Mansoureh
Position
Pharmacy student
Other areas of specialty/work
Street address
School of pharmacy, Pardis university campus, Park square
City
Mashhad
Postal code
91775-1365
Phone
+98 51 1882 3255
Fax
+98 51 1882 3251
Email
Zamanzadehm861@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)