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

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

Sponsors

Lead sponsor: Ain Shams University

Source 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 .

Overall Status Active, not recruiting
Start Date April 24, 2019
Completion Date August 2019
Primary Completion Date August 2019
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Effect on Markers of Endothelial Dysfunction(The change in the level of soluble intercellular adhesion molecule ( ICAM) in serum using ELISA kit) three months
Secondary Outcome
Measure Time Frame
Effect on Glycemic Control (Measurement of fasting blood glucose ) three months
Effect on Glycemic Control (Measurement of glycated hemoglobin) three months
Effect on Lipid Profile ( Measurement of TC,TG, HDL-C,LDL-C) three months
Effect on Inflammatory Status ( Measurement of High sensitive C-Reactive Protein using ELISA kit) three months
Effect on Quality of Life ( Using Diabetes-39 questionnaire ) three months
Enrollment 50
Condition
Intervention

Intervention type: Dietary Supplement

Intervention name: Black Seed Oil

Description: Black seed oil soft gelatin capsule

Arm group label: Group I

Other name: Nigella sativa oil

Intervention type: Drug

Intervention name: Anti-Diabetics

Description: standard anti-diabetic treatment prescribed for the patient

Eligibility

Criteria:

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.

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility Ain Shams University Hospitals
Location Countries

Egypt

Verification Date

May 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Ain Shams University

Investigator full name: Amany Talaat Abdellatif El-Garf

Investigator title: Assistant Lecturer of Clinical Pharmacy, Faculty of Pharmacy

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Group I

Arm group type: Experimental

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 group label: Group II

Arm group type: Active Comparator

Description: this group of patients will receive their standard anti-diabetic treatment only

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov