Diabetes Mellitus, Type 2Phase 2NCT03959306
Efficacy of Black Seed Oil in Patients With Type 2 Diabetes Mellitus
A Phase 2 study testing Black Seed Oil and Anti-Diabetics in people with Diabetes Mellitus, Type 2, run by Ain Shams University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Black Seed Oil and Anti-Diabetics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Apr 2019to Aug 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Black Seed Oil, Anti-Diabetics
- Keywords
- Type 2 Diabetes Mellitus, Black Seed Oil, Endothelial Dysfunction
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black Seed OilDietary supplement
Also called Nigella sativa oil
Black seed oil soft gelatin capsule
Anti-DiabeticsDrug
standard anti-diabetic treatment prescribed for the patient
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Black Seed Oil; Drug: Anti-Diabetics |
| Group II | Active comparator | this group of patients will receive their standard anti-diabetic treatment only Receives: Drug: Anti-Diabetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: three months
Secondary outcomes (5)
Effect on Glycemic Control (Measurement of fasting blood glucose )
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)
Measured: three months
Effect on Glycemic Control (Measurement of glycated hemoglobin)
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)
Measured: three months
Effect on Lipid Profile ( Measurement of TC,TG, HDL-C,LDL-C)
it will be assessed at baseline and after three months of treatment
Measured: three months
Effect on Inflammatory Status ( Measurement of High sensitive C-Reactive Protein using ELISA kit)
it will be assessed at baseline and after three months of treatment
Measured: three months
Effect on Quality of Life ( Using Diabetes-39 questionnaire )
it will be assessed at baseline and after three months of treatment
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start24 Apr 2019
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Talaat Abdellatif El-Garf, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959306
- Sponsor's protocol ID
- PHCL14
- Status last verified
- May 2019
- First submitted
- 18 May 2019
- Last updated
- 22 May 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Black Seed Oil on Markers of Endothelial Dysfunction in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03959306
- Acronym / sponsor ID
- PHCL14
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 Diabetes Mellitus, Black Seed Oil, Endothelial Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Dietary Supplement: Black Seed Oil, Drug: Anti-Diabeticsthis 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 II | Active comparator | Drug: Anti-Diabeticsthis group of patients will receive their standard anti-diabetic treatment only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Black Seed OilAlso: Nigella sativa oilBlack seed oil soft gelatin capsule | Dietary supplement | Group I |
| Anti-Diabeticsstandard anti-diabetic treatment prescribed for the patient | Drug | Group I, Group II |
Primary outcome
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
5 secondary outcomes
Effect on Glycemic Control (Measurement of fasting blood glucose )
Time frame: three months
Effect on Glycemic Control (Measurement of glycated hemoglobin)
Time frame: three months
Effect on Lipid Profile ( Measurement of TC,TG, HDL-C,LDL-C)
Time frame: three months
Effect on Inflammatory Status ( Measurement of High sensitive C-Reactive Protein using ELISA kit)
Time frame: three months
Effect on Quality of Life ( Using Diabetes-39 questionnaire )
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Black Seed Oil and Anti-Diabetics in people with Diabetes Mellitus, Type 2, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2019; AzTrials last refreshed its copy on 7 Nov 2026.