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

Ain Shams University

Status and phase: Unknown; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Anti-Diabetics; Dietary Supplement: Black Seed Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT03959306

PHCL14

Details and patient eligibility

About

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 .

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Group I

Experimental group

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

Treatment:

Dietary Supplement: Black Seed Oil

Drug: Anti-Diabetics

Group II

Active Comparator group

Description:

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

Treatment:

Drug: Anti-Diabetics