Back to resultsEfficacy of Black Seed Oil in Patients With Type 2 Diabetes Mellitus
Primary Purpose
Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Black Seed Oil
Anti-Diabetics
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 Diabetes Mellitus, Black Seed Oil, Endothelial Dysfunction
Eligibility Criteria
Inclusion Criteria:
- Age: adult patients with more than or equal 18 years old.
- Previous diagnosis of Diabetes mellitus type 2 according to American Diabetes Association Criteria (ADA).
- Approval to participate and give informed consent.
Exclusion Criteria:
- Unstable coronary artery disease, cardiac arrhythmia or congestive heart failure.
- Uncontrolled hypertension or recent stroke.
- Chronic kidney disease or chronic liver disease.
- Intake of black seed oil during the previous two months or any other antioxidant.
Sites / Locations
- Ain Shams University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group I
Group II
Arm Description
this group of patients will receive their standard anti-diabetic treatment in addition to 1800 mg of black seed oil soft gelatin capsule (900 mg twice daily) for three months
this group of patients will receive their standard anti-diabetic treatment only
Outcomes
Primary Outcome Measures
Effect on Markers of Endothelial Dysfunction(The change in the level of soluble intercellular adhesion molecule ( ICAM) in serum using ELISA kit)
it will be assessed at baseline and after three months of treatment ( to determine the change from baseline at three months ) to determine whether it is effective in reducing marker of endothelial dysfunction (ICAM) in patients with type 2 diabetes mellitus
Secondary Outcome Measures
Effect on Glycemic Control (Measurement of fasting blood glucose )
it will be assessed at baseline and after three months of treatment to determine the anti-diabetic effect of black seed oil ( if it is effective in reducing fasting blood glucose from baseline)
Effect on Glycemic Control (Measurement of glycated hemoglobin)
it will be assessed at baseline and after three months of treatment to determine the anti-diabetic effect of black seed oil ( if it is effective in reducing glycated hemoglobin from baseline)
Effect on Lipid Profile ( Measurement of TC,TG, HDL-C,LDL-C)
it will be assessed at baseline and after three months of treatment
Effect on Inflammatory Status ( Measurement of High sensitive C-Reactive Protein using ELISA kit)
it will be assessed at baseline and after three months of treatment
Effect on Quality of Life ( Using Diabetes-39 questionnaire )
it will be assessed at baseline and after three months of treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03959306
Brief Title
Efficacy of Black Seed Oil in Patients With Type 2 Diabetes Mellitus
Official Title
Effect of Black Seed Oil on Markers of Endothelial Dysfunction in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 24, 2019 (Actual)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the effect of black seed oil on markers of endothelial dysfunction in patients with type 2 diabetes mellitus .Also, to investigate its effect on glycemic control ,lipid profile and quality of life of those patients .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Type 2 Diabetes Mellitus, Black Seed Oil, Endothelial Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Experimental
Arm Description
this group of patients will receive their standard anti-diabetic treatment in addition to 1800 mg of black seed oil soft gelatin capsule (900 mg twice daily) for three months
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
this group of patients will receive their standard anti-diabetic treatment only
Intervention Type
Dietary Supplement
Intervention Name(s)
Black Seed Oil
Other Intervention Name(s)
Nigella sativa oil
Intervention Description
Black seed oil soft gelatin capsule
Intervention Type
Drug
Intervention Name(s)
Anti-Diabetics
Intervention Description
standard anti-diabetic treatment prescribed for the patient
Primary Outcome Measure Information:
Title
Effect on Markers of Endothelial Dysfunction(The change in the level of soluble intercellular adhesion molecule ( ICAM) in serum using ELISA kit)
Description
it will be assessed at baseline and after three months of treatment ( to determine the change from baseline at three months ) to determine whether it is effective in reducing marker of endothelial dysfunction (ICAM) in patients with type 2 diabetes mellitus
Time Frame
three months
Secondary Outcome Measure Information:
Title
Effect on Glycemic Control (Measurement of fasting blood glucose )
Description
it will be assessed at baseline and after three months of treatment to determine the anti-diabetic effect of black seed oil ( if it is effective in reducing fasting blood glucose from baseline)
Time Frame
three months
Title
Effect on Glycemic Control (Measurement of glycated hemoglobin)
Description
it will be assessed at baseline and after three months of treatment to determine the anti-diabetic effect of black seed oil ( if it is effective in reducing glycated hemoglobin from baseline)
Time Frame
three months
Title
Effect on Lipid Profile ( Measurement of TC,TG, HDL-C,LDL-C)
Description
it will be assessed at baseline and after three months of treatment
Time Frame
three months
Title
Effect on Inflammatory Status ( Measurement of High sensitive C-Reactive Protein using ELISA kit)
Description
it will be assessed at baseline and after three months of treatment
Time Frame
three months
Title
Effect on Quality of Life ( Using Diabetes-39 questionnaire )
Description
it will be assessed at baseline and after three months of treatment
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: adult patients with more than or equal 18 years old.
Previous diagnosis of Diabetes mellitus type 2 according to American Diabetes Association Criteria (ADA).
Approval to participate and give informed consent.
Exclusion Criteria:
Unstable coronary artery disease, cardiac arrhythmia or congestive heart failure.
Uncontrolled hypertension or recent stroke.
Chronic kidney disease or chronic liver disease.
Intake of black seed oil during the previous two months or any other antioxidant.
Facility Information:
Facility Name
Ain Shams University Hospitals
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Black Seed Oil in Patients With Type 2 Diabetes Mellitus
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