Comparison of the effects of Nigella sativa seed oil mixed with honey and placebo on the hepatic sonography and blood biochemical parameters of non-alcoholic fatty liver disease patients
Comparison of the effectiveness of Nigella sativa seed oil mixed with honey and placebo in the treatment of non-alcoholic fatty liver disease patients
Design
Randomized; block randomization with computer generated random numbers table and sequentially numbered containers each representing a block consisting of ten patients are used for the treatment assignments; double-blind; controlled with placebo; two group parallel design; single-center; phase 3 of clinical trial. Study population: patients with non-alcoholic fatty liver disease. Sample size: 120 patients.
Settings and conduct
The trial setting: Baqiyatallah Hospital. Protocol: sixty patients use 2.5 mL of Nigella sativa seed oil and 60 patients use 2.5 mL placebo orally every 12 hours for 3 months. Before intervention and 3 months after intervention the groups' liver sonography and blood levels of ALT, AST, LDL-C, HDL-C and triglyceride are compared with each other. Blinding: three different persons generate the random allocation sequence, enroll the participants and assign them to intervention groups. These persons, care providers, outcome assessors, data analyzer, investigators and participants are blinded to assignment to the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients whose hepatic sonography shows they have fatty liver disease; age of 20 to 70 years. Exclusion criteria: Child-Pugh score above 7; hepatic disease other than non-alcoholic fatty liver disease; pregnant women; women planning pregnancy; lactating women.
Intervention groups
Sixty patients use 2.5 mL of Nigella sativa seed oil and 60 patients use 2.5 mL of placebo orally every 12 hours for 3 months.
Main outcome variables
Primary outcome variables: fatty liver grade, blood level of ALT, blood level of AST, blood level of LDL-C, blood level of triglyceride. Secondary outcome variable: blood level of HDL-C.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090804002288N13
Registration date:2018-06-06, 1397/03/16
Registration timing:retrospective
Last update:2018-06-06, 1397/03/16
Update count:0
Registration date
2018-06-06, 1397/03/16
Registrant information
Name
Saeed Kianbakht
Name of organization / entity
Iranian Academic Center for Education, Culture and Research Institute of Medicinal Plants
Country
Iran (Islamic Republic of)
Phone
+98 26147640109
Email address
kianbakht@imp.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2018-04-20, 1397/01/31
Actual recruitment start date
2017-04-04, 1396/01/15
Actual recruitment end date
2018-04-20, 1397/01/31
Trial completion date
empty
Scientific title
Comparison of the effects of Nigella sativa seed oil mixed with honey and placebo on the hepatic sonography and blood biochemical parameters of non-alcoholic fatty liver disease patients
Public title
Effect of Nigella sativa seed oil in treatment of non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients whose hepatic sonography shows they have fatty liver disease
Age of 20 to 70 years
Exclusion criteria:
Child-Pugh score above 7
Hepatic disease other than non-alcoholic fatty liver disease
Pregnant women
Women planning pregnancy
Lactating women
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with computer generated random numbers table and sequentially numbered containers each representing a block consisting of ten patients are used for the treatment assignments.
Blinding (investigator's opinion)
Double blinded
Blinding description
Three different persons generate the random allocation sequence, enroll the participants and assign them to intervention groups. These persons, care providers, outcome assessors, data analyzer, investigators and participants are blinded to assignment to the Nigella sativa seed oil and placebo groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
Molla Sadra Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2015-11-01, 1394/08/10
Ethics committee reference number
IR.BMSU.REC.1394.149
Health conditions studied
1
Description of health condition studied
Non-alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Fatty liver grade
Timepoint
Before intervention and 3 monthس after intervention
Method of measurement
Liver sonography
2
Description
Blood level of ALT
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Medical laboratory (kit)
3
Description
Blood level of AST
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Medical laboratory (kit)
4
Description
Blood level of LDL-C
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Medical laboratory (kit)
5
Description
Blood level of triglyceride
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Medical laboratory (kit)
Secondary outcomes
1
Description
Blood level of HDL-C
Timepoint
Before intervention and 3 month after intervention
Method of measurement
Medical laboratory (kit)
Intervention groups
1
Description
Intervention group: sixty patients use 2.5 mL of Nigella sativa seed oil orally every 12 hours for 3 months.
Category
Treatment - Drugs
2
Description
Control group: sixty patients use 2.5 mL of placebo orally every 12 hours for 3 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Dr. Reza Mohtashami
Street address
Molla Sadra Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0435
Email
reza_mohtashami1979@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Dr. Reza Hajiaghaee
Street address
ACECR Complex, Supa Boulevard, Poleh Kordan
City
Karaj
Province
Alborz
Postal code
3365166571
Phone
+98 26 3476 4010
Email
hajiaghaee@imp.ac.ir
Web page address
http://www.imp.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
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
Iranian academic center for education culture and research
Full name of responsible person
Dr. Saeed Kianbakht
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
Institute of Medicinal Plants, ACECR Complex, Supa Boulevard, Poleh Kordan
City
Karaj
Province
Alborz
Postal code
3365166571
Phone
+98 26 3476 4010
Email
kianbakht@imp.ac.ir
Web page address
http://www.imp.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Dr. Saeed Kianbakht
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
Institute of Medicinal Plants, ACECR Complex, Supa Boulevard, Poleh Kordan
City
Karaj
Province
Alborz
Postal code
3365166571
Phone
+98 26 3476 4010
Email
kianbakht@imp.ac.ir
Web page address
http://www.imp.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Dr. Saeed Kianbakht
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
Institute of Medicinal Plants, ACECR Complex, Supa Boulevard, Poleh Kordan
City
Karaj
Province
Alborz
Postal code
3365166571
Phone
+98 26 3476 4010
Email
kianbakht@imp.ac.ir
Web page address
http://www.imp.ac.ir
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
Yes - There is a plan to make this available
Informed Consent Form
No - There is not 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 collected deidentified IPD are to be shared.
When the data will become available and for how long
Access period starting 6 months after publication for 1 year.
To whom data/document is available
Researchers working in university and scientific and industrial institutes.
Under which criteria data/document could be used
Only statistical analyses mentioned in the article resulting from the study for personal knowledge are permitted. Written request for access to data and documents and its aim must be certified by the highest ranking official of the work place of the requester.
From where data/document is obtainable
Dr. Saeed Kianbakht with the address ACECR Institute of Medicinal plants, P.O. Box: 31375-369, Iran.
What processes are involved for a request to access data/document
Written request should be sent to the address Dr. Saeed Kianbakht, ACECR Institute of Medicinal Plants, P.O. Box: 31375-369, Iran. The documents or data file will be sent to the requester by email.