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

NCT03959306 | Unknown Phase 2 FDA Drug

• 1 other identifier: PHCL14
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 .

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 Diabetes Mellitus; Black Seed Oil; Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

  three months

Secondary Outcomes (5)

• Effect on Glycemic Control (Measurement of fasting blood glucose )

  three months

• Effect on Glycemic Control (Measurement of glycated hemoglobin)

  three months

• Effect on Lipid Profile ( Measurement of TC,TG, HDL-C,LDL-C)

  three months

• Effect on Inflammatory Status ( Measurement of High sensitive C-Reactive Protein using ELISA kit)

  three months

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

  three months

Study Arms (2)

Group I

EXPERIMENTAL

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; Drug: Anti-Diabetics

Group II

ACTIVE COMPARATOR

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

Drug: Anti-Diabetics

Interventions

Black Seed Oil DIETARY_SUPPLEMENT

Black seed oil soft gelatin capsule

Also known as: Nigella sativa oil

Group I

Anti-Diabetics DRUG

standard anti-diabetic treatment prescribed for the patient

Group I; Group II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: adult patients with more than or equal 18 years old.
• Previous diagnosis of Diabetes mellitus type 2 according to American Diabetes Association Criteria (ADA).
• Approval to participate and give informed consent.

You may not qualify if:

• Unstable coronary artery disease, cardiac arrhythmia or congestive heart failure.
• Uncontrolled hypertension or recent stroke.
• Chronic kidney disease or chronic liver disease.
• Intake of black seed oil during the previous two months or any other antioxidant.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Nigella sativa oil; Hypoglycemic Agents

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Clinical Pharmacy, Faculty of Pharmacy

Study Record Dates

• First Submitted: May 18, 2019
• First Posted: May 22, 2019
• Study Start: April 24, 2019
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: May 22, 2019

Record last verified: 2019-05

Locations

EG (1)