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

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ClinicalTrials.gov Identifier: NCT03959306
Recruitment Status : Active, not recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Amany Talaat Abdellatif El-Garf, 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 .

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Dietary Supplement: Black Seed Oil Drug: Anti-Diabetics Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Black Seed Oil on Markers of Endothelial Dysfunction in Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : April 24, 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959306


Locations
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Egypt
Ain Shams University Hospitals
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University

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Responsible Party: Amany Talaat Abdellatif El-Garf, Assistant Lecturer of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University
ClinicalTrials.gov Identifier: NCT03959306     History of Changes
Other Study ID Numbers: PHCL14
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019

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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
Keywords provided by Amany Talaat Abdellatif El-Garf, Ain Shams University:
Type 2 Diabetes Mellitus
Black Seed Oil
Endothelial Dysfunction
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs