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

Phase 2

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Dietary Supplement: Black Seed Oil; Drug: Anti-Diabetics

• Registration Number: NCT03959306
• Lead Sponsor: Ain Shams University

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 .

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-04-24
• Status Verified: 2019-05
• Study First Submitted: 2019-05-18
• Study First Submitted QC: 2019-05-20
• Last Update Submitted: 2019-05-20
• Study First Posted: 2019-05-22
• Last Update Posted: 2019-05-22
• Primary Completion: 2019-08
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Age: adult patients with more than or equal 18 years old.
2. Previous diagnosis of Diabetes mellitus type 2 according to American Diabetes Association Criteria (ADA).
3. Approval to participate and give informed consent.

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Exclusion Criteria

1. Unstable coronary artery disease, cardiac arrhythmia or congestive heart failure.
2. Uncontrolled hypertension or recent stroke.
3. Chronic kidney disease or chronic liver disease.
4. Intake of black seed oil during the previous two months or any other antioxidant.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	Anti-Diabetics	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 I	Black Seed Oil	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	Anti-Diabetics	this group of patients will receive their standard anti-diabetic treatment only

Primary Outcome Measures

Name	Time	Method
Effect on Markers of Endothelial Dysfunction(The change in the level of soluble intercellular adhesion molecule ( ICAM) in serum using ELISA kit)	three months	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

Name	Time	Method
Effect on Glycemic Control (Measurement of fasting blood glucose )	three months	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)	three months	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)	three months	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)	three months	it will be assessed at baseline and after three months of treatment
Effect on Quality of Life ( Using Diabetes-39 questionnaire )	three months	it will be assessed at baseline and after three months of treatment

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Egypt