Nigella sativa seeds are used to treat several diseases including diabetes mellitus in the Iranian traditional medicine. The present study was undertaken to explore the anti-hyperglycemic effect of Nigella sativa (N. sativa) oil in type 2 diabetic patients. Seventy type 2 diabetic patients with fasting blood glucose levels between 140 and 180 mg/dl, body weight between 55 and 75 kg and diabetic disease duration of 2 to 8 years were selected from those diabetic patients referring to Baqiyatallah Hospital. The patients were randomly enrolled in to two groups of 35 each. The study was double-blind (participants and care providers were blind to treatments) and block randomization was used for allocation of patients to the N. sativa oil and the placebo groups. The patients in N. sativa group received 2.5 ml N. sativa oil and the patients in placebo group received similarly 2.5 ml mineral oil two times a day for three months. The patients were advised to continue the drug regimen that was previously prescribed. The fasting and 2 hour postprandial blood glucose and glycosylated hemoglobin (HbA1C) levels were determined in both the groups at baseline and after three months as a main outcome measures.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207301157N7
Registration date:2013-08-08, 1392/05/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-08, 1392/05/17
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 and Baqiyatallah University of Medical Sciences
Expected recruitment start date
2012-05-22, 1391/03/02
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Nigella sativa L. seed oil in treatment of type 2 diabetic patients: a placebo-controlled clinical trial
Public title
Efficacy of Nigella sativa L. seed oil in treatment of type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Type 2 diabetic patients with fasting blood glucose levels between 140 and 180 mg/dl; body weight between 55 and 75 kg; age between 34 and 63 years; disease duration of 2 to 8 years; taking no more than two 500 mg metformin and two 5 mg glyburide tablets every day.
Exclusion criteria: Patients receiving insulin therapy; patients with cardiac, renal, hepatic and hematological diseases; patients with a history of gallstones or gall bladder surgery; patients using estrogen, steroid, beta-blocker and thiazide drugs; pregnant and breast-feeding women; alcohol consuming and cigarette smoking patients.
Age
From 34 years old to 63 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 Ethics Committee
Street address
Vanak square, Molasadra Ave
City
Tehran
Postal code
Approval date
2011-12-03, 1390/09/12
Ethics committee reference number
340/22/س
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E10, E14,
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Fasting blood glucose
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood glucose level was determined in laboratory by commercially available kit
2
Description
Glycosylated hemoglobin (HbA1C)
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood HbA1c level was determined in laboratory by commercially available kit
3
Description
2 hours postprandial blood glucose
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood glucose level was determined in laboratory by commercially available kit
Secondary outcomes
1
Description
BMI (Body mass index)
Timepoint
At starting of the study and after 3 months
Method of measurement
Height and weight using measure tape and weight scales
2
Description
Triglyceride
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood triglyceride level was determined in laboratory by commercially available kit
3
Description
Cholesterol
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood cholesterol level was determined in laboratory by commercially available kit
4
Description
low-density lipoprotein (LDL)
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood LDL level was determined in laboratory by commercially available kit
5
Description
High-density lipoprotein (HDL)
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood HDL level was determined in laboratory by commercially available kit
6
Description
Serum glutamic oxaloacetic transaminase (SGOT)
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood SGOT level was determined in laboratory by commercially available kit
7
Description
Serum glutamic pyruvic transaminase (SGPT)
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood SGPT level was determined in laboratory by commercially available kit
8
Description
Creatinine
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood creatinine level was determined in laboratory by commercially available kit
9
Description
Alkaline phosphatase (ALP)
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood ALP level was determined in laboratory by commercially available kit
Intervention groups
1
Description
Intervention group: Received 2.5 ml N. sativa oil two times a day orally for three months
Category
Treatment - Drugs
2
Description
Placebo group: Received 2.5 ml mineral oil orally two times a day for three months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah University of Medical Sciences
Full name of responsible person
Mahbobah Sadat Hosseini
Street address
Vanak square, Molasadra Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Institute of Medicinal Plants
Full name of responsible person
Reza Hajiaghaee
Street address
Research Complex of Jahad Daneshgahi, ACECR, Kavosh Boulevard, Supa Boulevard, Karaj-Qazvin Highway
City
Karaj
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
Vice chancellor for research, Institute of Medicinal Plants
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
Vice chancellor for research, Religion and Medicine Research Center, Baqiyatallah University of Medi
Full name of responsible person
Mahbobeh Sadat Hosseini
Street address
Vanak square, Molasadra Ave
City
Tehran
Grant name
روغن سياه دانه 1/1389/456
Grant code / Reference number
111-306
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Religion and Medicine Research Center, Baqiyatallah University of Medi
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
Hasan Fallah Huseini
Position
Ph.D.
Other areas of specialty/work
Street address
Research Complex of Jahad Daneshgahi, ACECR, Kavosh Boulevard, Supa Boulevard, Karaj-Qazvin Highway
City
Karaj
Postal code
13601360
Phone
+98 26 3476 4010
Fax
+98 26 3476 4021
Email
huseini_fallah@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Mahbobah Sadat Hosseini
Position
M.D. Endocrinologist
Other areas of specialty/work
Street address
Vanak square, Molasadra Ave
City
Tehran
Postal code
1484958693
Phone
+98 21 8806 8923
Fax
+98 21 8806 8923
Email
m_hosseini440@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Institute of Medicinal Plants
Full name of responsible person
Hasan Fallah Huseini
Position
Ph.D.
Other areas of specialty/work
Street address
Research Complex of Jahad Daneshgahi, ACECR, Kavosh Boulevard, Supa Boulevard, Karaj-Qazvin Highway
City
Karaj
Postal code
13601360
Phone
+98 26 3476 4010
Fax
+98 26 3476 4021
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)