DiabetesEarly Phase 1NCT05898750
Antidiabetic Potiential of Moringa and Dom Extract
A Early Phase 1 study testing MorDom in people with Diabetes, run by Deraya University at 1 site in Egypt.
Trial summary
The Antidiabetic potential of Hyphaene thebaica fruits and Moringa oleifera leaves will be investigated in diabetic patients (type 2). The patients will be maintained on tea of both drugs for 6 weeks. The fasting blood glucose levels of patients will be checked on a daily basis. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- MorDom
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Apr 2023to 30 Jun 2023
- Phase
- Early Phase 1
- 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 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- diabetic patients type 2
Who cannot join
- liver failure
- heart failure
- renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antidiabetic Potential of Hyphanea Thebaica Fruits and Moringa Olifera Leaves
The Antidiabetic potential of Hyphaene thebaica fruits and Moringa oleifera leaves will be investigated in diabetic patients (type 2). The patients will be maintained on tea of both drugs for 6 weeks. The fasting blood glucose levels of patients will be checked on a daily basis. Other blood biomarkers will be also reported such as insulin concentration, Lipid profile, liver enzymes, c-peptide and glycated hemoglobin
- Conditions
- Diabetes
- Being tested
- MorDom
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorDomDietary supplement
oral powder in tea bags contains 4gm twice daily (equal concentration of each drugs)
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Dietary Supplement: MorDom |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose level
measured by fast blood test
Measured: 3 months
Secondary outcomes (4)
blood level of lipid profile
Blood samples were drawn to measure levels of LDL, HDL, triglycerides, total cholesterol
Measured: two weeks
Liver enzymes
Blood samples were drawn to measure levels of ALT and AST
Measured: two weeks
C-peptide level
Blood samples were drawn to measure fasting and postprandial levels of c-peptide
Measured: two weeks
Insulin level
Blood samples were drawn to measure fasting and postprandial levels of insulin
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start22 Apr 2023
- Primary completion22 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soad Ali, Deraya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898750
- Sponsor's protocol ID
- MorDom
- Status last verified
- Sep 2023
- First submitted
- 22 May 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antidiabetic Potential of Hyphanea Thebaica Fruits and Moringa Olifera Leaves
- ClinicalTrials.gov ID
- NCT05898750
- Acronym / sponsor ID
- MorDom
- Conditions
- Diabetes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Deraya UniversityUniversity, hospital or other
- Study start
- 22 Apr 2023 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 12 Jun 2023 (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 Antidiabetic potential of Hyphaene thebaica fruits and Moringa oleifera leaves will be investigated in diabetic patients (type 2). The patients will be maintained on tea of both drugs for 6 weeks. The fasting blood glucose levels of patients will be checked on a daily basis. Other blood biomarkers will be also reported such as insulin concentration, Lipid profile, liver enzymes, c-peptide and glycated hemoglobin
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Dietary Supplement: MorDom |
| Control group | No intervention | – |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- diabetic patients type 2
Key exclusion criteria (3 listed)
- liver failure
- heart failure
- renal failure
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 |
|---|---|---|
| MorDomoral powder in tea bags contains 4gm twice daily (equal concentration of each drugs) | Dietary supplement | experimental group |
Primary outcome
Blood glucose level
Time frame: 3 months
measured by fast blood test
4 secondary outcomes
blood level of lipid profile
Time frame: two weeks
Liver enzymes
Time frame: two weeks
C-peptide level
Time frame: two weeks
Insulin level
Time frame: two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
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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 Early Phase 1 study testing MorDom in people with Diabetes, run by Deraya 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 26 Sep 2023. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood glucose level (time frame: 3 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 26 Sep 2023.