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

Ain Shams University50 enrolled

Overview

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 .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

Black Seed OilDIETARY_SUPPLEMENT

Black seed oil soft gelatin capsule

Anti-DiabeticsDRUG

standard anti-diabetic treatment prescribed for the patient

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ain Shams University Hospitals

Cairo, Egypt

Outcomes

Primary Outcomes

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

Time frame: three months

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: three months

Effect on Quality of Life ( Using Diabetes-39 questionnaire )

it will be assessed at baseline and after three months of treatment

Time frame: three months

Data from ClinicalTrials.gov

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