Efficacy of Black Seed Oil in Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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 .

Official Title
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Effect of Black Seed Oil on Markers of Endothelial Dysfunction in Patients With Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Dietary Supplement: Black Seed Oil
* Drug: Anti-Diabetics


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>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 | Dietary Supplement: Black Seed Oil<br>* Black seed oil soft gelatin capsule<br>* Other names: Nigella sativa oil;Drug: Anti-Diabetics<br>* standard anti-diabetic treatment prescribed for the patient<br>|
| Active Comparator: Group II<br>this group of patients will receive their standard anti-diabetic treatment only | Drug: Anti-Diabetics<br>* standard anti-diabetic treatment prescribed for the patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Black Seed Oil, Endothelial Dysfunction