Protocol summary

Summary
Background: Several formulations of the Nigella sativa L. seeds (black seed) have been used in traditional medicine for treatment and prevention of a wide range of diseases including hyperlipidemia. But blood lipid lowering effects of its oil in clinical study is of an interest. Objective: The present study was undertaken to explore the possible blood lipid lowering effects of the black seed oil on healthy volunteers. Methods: A randomized clinical trial was conducted in 70 healthy volunteers referring to Bagiatallah hospital. The subjects were randomly selected and enrolled in to two groups of 35 each. One group received 2.5 ml black seed oil and the other group received similarly 2.5 ml mineral oil two times a day. The fasting blood Triglyceride, Cholesterol, HDL, LDL, Glucose, ALT, AST, BUN, Cr, and HbA1C were determined at the baseline and after 8 weeks. Results: Results showed that significant decrease in fasting blood cholesterol, LDL, Triglyceride, glucose and HbA1c levels in black seed oil treated volunteers as compared to placebo group at the end of the study. No notable liver, kidney and gastrointestinal side effects were observed in these two groups side effects were observed in these two groups. Conclusion: Administration of 5 ml black seed oil daily to healthy volunteers for 8 weeks had beneficial effects on improving lipid profile without any adverse effects.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112271157N5
Registration date: 2012-01-05, 1390/10/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-01-05, 1390/10/15
Registrant information
Name
Hasan Fallah Huseini
Name of organization / entity
Institute of Medicinal Plants
Country
Iran (Islamic Republic of)
Phone
+98 26 3476 4010
Email address
fallah@imp.ac.ir
Recruitment status
Recruitment complete
Funding source
Institute of Medicinal Plants, ACECR and Baqiyatallah University of Medical Sciences
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2011-05-22, 1390/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Hypolipidemic effects of Nigella Sativa L. Seeds oil in healthy volunteers: a randomized, double-blind, placebo-controlled clinical trial
Public title
Hypolipidemic effects of Nigella Sativa L. seeds oil in healthy volunteers
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: healthy Iranian volunteers aged between 40 to 60 years; with fasting blood cholesterol 200 to 300 mg/dl; fasting blood glucose 80 to120 mg/dl and weight 55 to 85 kg
Age
From 25 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 70
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
Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
1484958693
Approval date
2010-12-12, 1389/09/21
Ethics committee reference number
22-340/s

Health conditions studied

1

Description of health condition studied
Healthy Volunteers
ICD-10 code
Z01
ICD-10 code description
Other special examinations and investigations of persons without complaint or reported diagnosis

Primary outcomes

1

Description
Cholesterole
Timepoint
At starting of the study and after 8 weeks
Method of measurement
The fasting blood cholesterl level determined in laboratory

Secondary outcomes

1

Description
SGPT
Timepoint
At starting of the study and after 8 weeks
Method of measurement
The fasting blood SGPT level determined in laboratory

2

Description
LDL
Timepoint
At starting of the study and after 8 weeks
Method of measurement
The fasting blood LDL level determined in laboratory

3

Description
Hba1c
Timepoint
At starting of the study and after 8 weeks
Method of measurement
The fasting blood Hba1c level determined in laboratory

4

Description
Glucose
Timepoint
At starting of the study and after 8 weeks
Method of measurement
The fasting blood Glucose level determined in laboratory

5

Description
Creatinine
Timepoint
At starting of the study and after 8 weeks
Method of measurement
The fasting blood Creatinine level determined in laboratory

6

Description
SGOT
Timepoint
At starting of the study and after 8 weeks
Method of measurement
The fasting blood SGOT level determined in laboratory

7

Description
BUN
Timepoint
At starting of the study and after 8 weeks
Method of measurement
The fasting blood BUN level determined in laboratory

8

Description
Triglyceride
Timepoint
At starting of the study and after 8 weeks
Method of measurement
determined in fasting blood sample in laboratory

9

Description
Hdl
Timepoint
At starting of the study and after 8 weeks
Method of measurement
determined in fasting blood sample in laboratory

Intervention groups

1

Description
2.5 ml black seed oil two times a day after meal for 8 weeks
Category
Treatment - Drugs

2

Description
2.5 ml mineral oil two times a day after meal for 8 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastroentrology and Liver diseases Research Center, Baqiyatallah University of Medical Sciences
Full name of responsible person
Mohtashami Reza
Street address
Vanak Squer, Molasadra Ave
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Institute of Medicinal Plants, ACECR
Full name of responsible person
Hassan ali Nqdi badi
Street address
Tehran-Qazwain Highway Research City Kavosh, Jahad daneshgahi research society Kraj
City
Kraj
Grant name
روغن سياه دانه: 84/ 1389/9/10 /س
Grant code / Reference number
1142-33
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Institute of Medicinal Plants, ACECR
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Reza Mohtashami
Street address
Baqiyatallah University of Medical Sciences,Tebo-o-Din Center, Vanak squer, Molasadra Ave,Tehran, Iran
City
Tehran
Grant name
456/l/1389
Grant code / Reference number
111-306
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatallah University of Medical Sciences
Proportion provided by this source
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
Institute of Medicinal Plants
Full name of responsible person
Hassan Fallah Huseini
Position
Ph.d
Other areas of specialty/work
Street address
Tehran-Qazwain High way Research city Kavosh, Jahad-Daneshgahi research soc iety , ACECR
City
kraj
Postal code
13601360
Phone
+98 26 1476 4010
Fax
+98 47 64021
Email
huseini_fallah@yahoo.com
Web page address
huseini_fallah@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Institute of Medicinal Plants, ACECR
Full name of responsible person
Fallah Huseini Hassan
Position
PhD
Other areas of specialty/work
Street address
Research city Kavosh, Jahad daneshgahi research society
City
kraj
Postal code
13601360
Phone
+98 26 1476 4010
Fax
+98 47 64021
Email
huseini_fallah@yahoo.com
Web page address
huseini_fallah@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Institute of Medicinal Plants, ACECR
Full name of responsible person
Fallah Huseini Hassan
Position
PhD
Other areas of specialty/work
Street address
Research city Kavosh, Jahad daneshgahi research society
City
kraj
Postal code
13601360
Phone
+98 26 1476 4010
Fax
+98 47 64021
Email
huseini_fallah@yahoo.com
Web page address
huseini_fallah@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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