Determine the effect of black seed powder on lipid profiles and glucose in type 2 diabetes
Design
A clinical trial with a control group, a randomized, single blind study. The sample size is 80 (40 in the experimental group and 40 in the control group).
Settings and conduct
Consumption of black seed powder for 2 months in the test group and placebo capsule in the control group.The site of the study is the Imam Khomeini Hospital in Khomein. Patients are unaware of being in a test or control group.
Participants/Inclusion and exclusion criteria
Diagnosis of type 2 diabetes (based on ADA criteria), Being treated with oral hypoglycaemic drugs. exclusion criteria: En According to patients' statements, they suffer from any mental or physical illness and consume medications; be pregnant.
Intervention groups
Consumption of black seed powder in the intervention group and taking placebo capsules in the control group
Main outcome variables
blood glucose; lipid profile
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170501033751N3
Registration date:2019-05-07, 1398/02/17
Registration timing:retrospective
Last update:2019-05-07, 1398/02/17
Update count:0
Registration date
2019-05-07, 1398/02/17
Registrant information
Name
rezvan ghafarzadegan
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3426 2226
Email address
rghafarzadegan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Black seed (Nigella Sativa) powder on serum glucose and Lipids level of type 2 diabetic patients
Public title
Effect of Black seed (Nigella Sativa) powder on diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years and under 60 years; at least 6 months passed from diabetes diagnosis. The patient does not have adequate glycemic control
Exclusion criteria:
According to patients' statements, they suffer from any mental or physical illness and consume drugs; be pregnant
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
randomized allocation
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients in the test and control group are not aware of their group. They are randomly assigned to the test and control groups and are not aware of the contents of the package containing the drug or placebo
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of khomein University of Medical Sciences
Street address
Qods Ave
City
khomein
Province
Markazi
Postal code
3881858573
Approval date
2018-10-16, 1397/07/24
Ethics committee reference number
Ir.khomein.rec.1397.009
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
E11
ICD-10 code description
type 2 diabetes mellitus
Primary outcomes
1
Description
blood glucose
Timepoint
Before the intervention and two months after starting the consume of Black seed (Nigella Sativa) powder
Method of measurement
Measurement of blood glucose level in the laboratory using an autoanalyzer
Secondary outcomes
1
Description
lipid profile
Timepoint
Before the intervention and two months after starting the consume of black seed powder
Method of measurement
Measurement of serum lipids levels in the laboratory using an autoanalyzer
Intervention groups
1
Description
Intervention group:Each capsule contains 500 milligrams of blackseed grains.One capsule per day orally(For two months) This capsule is manufactured by Institute of Medicinal Plants of Academic Jihad.
Category
Treatment - Drugs
2
Description
Control group: Take 500 mg capsules of placebo containing breadcrumbs.two capsule per day orally(For three months). This capsule is manufactured by Institute of Medicinal Plants of Academic Jihad.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital in khomein
Full name of responsible person
Rezvan Ghafarzadegan
Street address
Modarres Ave
City
khomein
Province
Markazi
Postal code
3881858573
Phone
+98 86 4633 2211
Email
rghafarzadegan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hamid Momeni
Street address
Modarres Ave
City
khomein
Province
Markazi
Postal code
3881858573
Phone
+98 86 4633 2211
Email
rghafarzadegan@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Rezvan Ghafarzadegan
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Modarres Ave
City
khomein
Province
Markazi
Postal code
3881858573
Phone
+98 86 4633 2211
Email
rghafarzadegan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hamid Momeni
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Modarers
City
khomein
Province
Markazi
Postal code
3881858573
Phone
+98 86 4633 2211
Email
hamid52us@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Rezvan Ghafarzadegan
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Modarres Ave
City
khomein
Province
Markazi
Postal code
3881857573
Phone
+98 86 4622 1533
Email
rghafarzadegan@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data is sharable when unrecognizable
When the data will become available and for how long
2019
To whom data/document is available
all researcher
Under which criteria data/document could be used
to related research
From where data/document is obtainable
khomein medical university
What processes are involved for a request to access data/document