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

May 20, 2019 updated by: Amany Talaat Abdellatif El-Garf, Ain Shams University

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain shams university hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Dietary supplement: Black Seed Oil
Black seed oil soft gelatin capsule
Other Names:
  • Nigella sativa oil
Drug: Anti-Diabetics
standard anti-diabetic treatment prescribed for the patient
Active Comparator: Group II
this group of patients will receive their standard anti-diabetic treatment only
Drug: Anti-Diabetics
standard anti-diabetic treatment prescribed for the patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on Markers of Endothelial Dysfunction(The change in the level of soluble intercellular adhesion molecule ( ICAM) in serum using ELISA kit)
Time Frame: 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
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on Glycemic Control (Measurement of fasting blood glucose )
Time Frame: 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)
three months
Effect on Glycemic Control (Measurement of glycated hemoglobin)
Time Frame: 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)
three months
Effect on Lipid Profile ( Measurement of TC,TG, HDL-C,LDL-C)
Time Frame: three months
it will be assessed at baseline and after three months of treatment
three months
Effect on Inflammatory Status ( Measurement of High sensitive C-Reactive Protein using ELISA kit)
Time Frame: three months
it will be assessed at baseline and after three months of treatment
three months
Effect on Quality of Life ( Using Diabetes-39 questionnaire )
Time Frame: three months
it will be assessed at baseline and after three months of treatment
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2019

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

May 18, 2019

First Submitted That Met QC Criteria

May 20, 2019

First Posted (Actual)

May 22, 2019

Study Record Updates

Last Update Posted (Actual)

May 22, 2019

Last Update Submitted That Met QC Criteria

May 20, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHCL14

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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