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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental | 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 |
|
| Group II | Active Comparator | this group of patients will receive their standard anti-diabetic treatment only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Black Seed Oil | Dietary Supplement | Black seed oil soft gelatin capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | three months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | three months |
| Effect on Glycemic Control (Measurement of glycated hemoglobin) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospitals | Cairo | Egypt |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000723271 | Nigella sativa oil |
| D007004 | Hypoglycemic Agents |
| ID | Term |
|---|---|
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Anti-Diabetics | Drug | standard anti-diabetic treatment prescribed for the patient |
|
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) |
| three months |
| Effect on Lipid Profile ( Measurement of TC,TG, HDL-C,LDL-C) | it will be assessed at baseline and after three months of treatment | three months |
| 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 | three months |
| Effect on Quality of Life ( Using Diabetes-39 questionnaire ) | it will be assessed at baseline and after three months of treatment | three months |
| D004700 | Endocrine System Diseases |