DiabetesPhase 1NCT02308683
Effects of Moringa Oleifera on hsCRP and Hgba1c Level of Patients in Ospital ng Maynila Medical Center Diabetic Clinic
A Phase 1 study testing Moringa oleifera in people with Diabetes, run by Ospital ng Maynila Medical Center.
Trial summary
Current evidence supports a central role of inflammation in the pathogenesis of atherosclerosis and diabetes [57-60]. Diabetes Mellitus type 2 is an inflammatory atherothrombotic condition associated with high prevalence of thrombotic cardiovascular disease. Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Moringa oleifera
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Nov 2014
- Phase
- 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 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female participants aged between 19 and 65 years of age.
- They were diagnosed by the Internal Medicine resident or other physician as having Diabetes Mellitus using the following criteria stated by American Diabetes Association (ADA)
- Participants should be willing to have their blood extracted for hsCRP and Hgba1c measurement before and after 12 weeks supplementation of M. oleifera.
- Participants have available treatment partner.
- Subjects who have been diagnosed with other diseases such as asthma, stroke, or hypertension was included in the trial provided since they are already medically stable and that these diseases are not listed as part of the exclusion criteria.
Who cannot join
- Subjects who are suspected to have psychiatric disorders, mentally challenged, or confirmed to be pregnant
- Subjects who are not medically stable or those confirmed to be afflicted with communicable or life threatening diseases such as but not limited to the following:
- ongoing infection (Pulmonary Tuberculosis, DM foot infection, cellulitis, pneumonia, Urinary Tract Infections, ear infections or dental/gum Infections)
- decompensated heart failure ( CHF III-IV)
- chronic liver disease in decompensated state
- stroke in evolution,
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- acute coronary syndrome within 6 months,
- systemic or pulmonary inflammatory condition (including rheumatoid arthritis, systemic lupus erythematosus,
- chronic obstructive pulmonary disease in exacerbation,
- bronchial asthma in exacerbation, history of renal or other organ transplant and/or
- immunocompromised state
- Subjects with anemia (hemoglobin value of less than 13.0 g/dl in males; 12.0 g/dl in females)
- Subjects with undergoing Moringa oleifera, fish oil or any vitamins or multivitamins supplementation within the past 8 weeks are excluded in the study.
- Subjects with the use of estrogen/progesterone hormone. Subjects with plan or anticipated by their physicians to be initiated with renal replacement therapy (dialysis) during the study.
- Subjects who are pregnant or plan to be pregnant.
- Subjects with known or suspected allergy to M. oleifera or any other component to the drug preparation.
About this study
Official title: The Effects of Moringa Oleifera Supplements on hsCRP and HgbA1c Levels of Patients in Ospital ng Maynila Medical Center Diabetic Clinic: A Prospective Cohort Study
Current evidence supports a central role of inflammation in the pathogenesis of atherosclerosis and diabetes [57-60]. Diabetes Mellitus type 2 is an inflammatory atherothrombotic condition associated with high prevalence of thrombotic cardiovascular disease. In patient with DM type 2, this inflammation is reflected by elevated plasma levels of several biomarkers of inflammation such as C-reactive protein (CRP) [51-55]. HsCRP is considered as a strong predictive of cardiovascular risks and death [53, 61-72]. Besides its predictive role in determining cardiovascular risk, there is some evidence that CRP may represent an active participant in atherogenesis [54]. CRP is expressed in human atherosclerotic plaques and both vascular cells and monocytes/macrophages appear to represent a significant source of CRP in the inflammatory vessel wall [54].
Among the DM risk factors (like hypertension, atherogenic dyslipidemia, insulin resistance, impaired fibrinolysis, inflammatory profile), definitely, inflammation is the neglected one.
Read more
Moringa oleifera has been suggested to exert anti-inflammatory effects [42][43][45] and hypoglycemic property [80]. As with many reports of the nutritional or medicinal value of a natural product, there are an alarming number of purveyors of "healthful" food who are now promoting M. oleifera as a panacea. While much of this recent enthusiasm indeed appears to be justified, it is critical to separate scientific evidence from anecdote.
Herein, the investigators will investigate the effects of Moringa oleifera leaves supplementation on levels of inflammatory marker specifically hsCRP, hgbA1c level and clinical outocome in diabetic patients through a cohort study.
Read the detailed description
We performed a prospective cohort study of adult diabetics who were given 12-weeks supplementation of Moringa oleifera. Plasma hsCRP and serum HgbA1c were compared before and after treatment with M. oleifera.
- Conditions
- Diabetes
- Being tested
- Moringa oleifera
- Keywords
- hscrp, hgba1c, diabetes mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moringa oleiferaDietary supplement
Also called Malungay
12 weeks supplementation
| Study group | Role | What they receive |
|---|---|---|
| hsCRP, Hgba1c | Experimental | Pre treatment hsCRP and hgba1c will be initially measured After 12 weeks supplementation of Moringa oleifera, post treatment hsCRP and Hgba1c will be measured Receives: Dietary Supplement: Moringa oleifera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post treatment mean HsCRP
Measured: 12 weeks
Secondary outcomes (1)
Post treatment mean hgba1c
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionNov 2014
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
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospital ng Maynila Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rainier N. Mozo, Ospital ng Maynila Medical Center
- Investigators
- Rainier Mozo, Dr, Principal investigator, Ospital ng Maynila Medical Center Department of Internal Medicine and ICU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308683
- Sponsor's protocol ID
- Moringa oleifera
- Status last verified
- Dec 2014
- First submitted
- 2 Dec 2014
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Moringa Oleifera Supplements on hsCRP and HgbA1c Levels of Patients in Ospital ng Maynila Medical Center Diabetic Clinic: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02308683
- Acronym / sponsor ID
- Moringa oleifera
- Conditions
- Diabetes
- Keywords
- hscrp, hgba1c, diabetes mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ospital ng Maynila Medical CenterUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 4 Dec 2014 (estimated)
- 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.
Current evidence supports a central role of inflammation in the pathogenesis of atherosclerosis and diabetes [57-60]. Diabetes Mellitus type 2 is an inflammatory atherothrombotic condition associated with high prevalence of thrombotic cardiovascular disease. In patient with DM type 2, this inflammation is reflected by elevated plasma levels of several biomarkers of inflammation such as C-reactive protein (CRP) [51-55]. HsCRP is considered as a strong predictive of cardiovascular risks and death [53, 61-72]. Besides its predictive role in determining cardiovascular risk, there is some evidence that CRP may represent an active participant in atherogenesis [54]. CRP is expressed in human atherosclerotic plaques and both vascular cells and monocytes/macrophages appear to represent a significant source of CRP in the inflammatory vessel wall [54].
Among the DM risk factors (like hypertension, atherogenic dyslipidemia, insulin resistance, impaired fibrinolysis, inflammatory profile), definitely, inflammation is the neglected one.
Moringa oleifera has been suggested to exert anti-inflammatory effects [42][43][45] and hypoglycemic property [80]. As with many reports of the nutritional or medicinal value of a natural product, there are an alarming number of purveyors of "healthful" food who are now promoting M. oleifera as a panacea. While much of this recent enthusiasm indeed appears to be justified, it is critical to separate scientific evidence from anecdote.
Herein, the investigators will investigate the effects of Moringa oleifera leaves supplementation on levels of inflammatory marker specifically hsCRP, hgbA1c level and clinical outocome in diabetic patients through a cohort study.
Detailed description
We performed a prospective cohort study of adult diabetics who were given 12-weeks supplementation of Moringa oleifera. Plasma hsCRP and serum HgbA1c were compared before and after treatment with M. oleifera.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hsCRP, Hgba1c | Experimental | Dietary Supplement: Moringa oleiferaPre treatment hsCRP and hgba1c will be initially measured After 12 weeks supplementation of Moringa oleifera, post treatment hsCRP and Hgba1c will be measured |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female participants aged between 19 and 65 years of age.
- They were diagnosed by the Internal Medicine resident or other physician as having Diabetes Mellitus using the following criteria stated by American Diabetes Association (ADA)
- Participants should be willing to have their blood extracted for hsCRP and Hgba1c measurement before and after 12 weeks supplementation of M. oleifera.
- Participants have available treatment partner.
- Subjects who have been diagnosed with other diseases such as asthma, stroke, or hypertension was included in the trial provided since they are already medically stable and that these diseases are not listed as part of the exclusion criteria.
Key exclusion criteria (16 listed)
- Subjects who are suspected to have psychiatric disorders, mentally challenged, or confirmed to be pregnant
- Subjects who are not medically stable or those confirmed to be afflicted with communicable or life threatening diseases such as but not limited to the following:
- Subjects with anemia (hemoglobin value of less than 13.0 g/dl in males; 12.0 g/dl in females)
- Subjects with undergoing Moringa oleifera, fish oil or any vitamins or multivitamins supplementation within the past 8 weeks are excluded in the study.
- Subjects with the use of estrogen/progesterone hormone. Subjects with plan or anticipated by their physicians to be initiated with renal replacement therapy (dialysis) during the study.
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 |
|---|---|---|
| Moringa oleiferaAlso: Malungay12 weeks supplementation | Dietary supplement | hsCRP, Hgba1c |
Primary outcome
Post treatment mean HsCRP
Time frame: 12 weeks
1 secondary outcome
Post treatment mean hgba1c
Time frame: 12 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 4 Dec 2014.
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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.
Rainier Mozo, Dr principal investigator
Ospital ng Maynila Medical Center Department of Internal Medicine and ICU
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Moringa oleifera in people with Diabetes, run by Ospital ng Maynila Medical Center.
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 5 inclusion and 16 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 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Post treatment mean HsCRP (time frame: 12 weeks). 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 4 Dec 2014.