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

NCT ID: NCT03959306

Last Updated: 2019-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-24

Study Completion Date

2019-08-31

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 .

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group I

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 Type EXPERIMENTAL

Black Seed Oil

Intervention Type DIETARY_SUPPLEMENT

Black seed oil soft gelatin capsule

Anti-Diabetics

Intervention Type DRUG

standard anti-diabetic treatment prescribed for the patient

Group II

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

Group Type ACTIVE_COMPARATOR

Anti-Diabetics

Intervention Type DRUG

standard anti-diabetic treatment prescribed for the patient

Interventions

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Black Seed Oil

Black seed oil soft gelatin capsule

Intervention Type DIETARY_SUPPLEMENT

Anti-Diabetics

standard anti-diabetic treatment prescribed for the patient

Intervention Type DRUG

Other Intervention Names

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Nigella sativa oil

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Amany Talaat Abdellatif El-Garf

Assistant Lecturer of Clinical Pharmacy, Faculty of Pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University Hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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PHCL14

Identifier Type: -

Identifier Source: org_study_id

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