Effects of Moringa Oleifera on hsCRP and Hgba1c Level of Patients in Ospital ng Maynila Medical Center Diabetic Clinic

December 3, 2014 updated by: Rainier N. Mozo, Ospital ng Maynila Medical Center

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female participants aged between 19 and 65 years of age.
  2. 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)
  3. Participants should be willing to have their blood extracted for hsCRP and Hgba1c measurement before and after 12 weeks supplementation of M. oleifera.
  4. Participants have available treatment partner.
  5. 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.

Exclusion Criteria:

  1. Subjects who are suspected to have psychiatric disorders, mentally challenged, or confirmed to be pregnant

  2. 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,
    • 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
  3. Subjects with anemia (hemoglobin value of less than 13.0 g/dl in males; 12.0 g/dl in females)
  4. Subjects with undergoing Moringa oleifera, fish oil or any vitamins or multivitamins supplementation within the past 8 weeks are excluded in the study.
  5. 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.
  6. Subjects who are pregnant or plan to be pregnant.
  7. Subjects with known or suspected allergy to M. oleifera or any other component to the drug preparation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: hsCRP, Hgba1c
Pre treatment hsCRP and hgba1c will be initially measured After 12 weeks supplementation of Moringa oleifera, post treatment hsCRP and Hgba1c will be measured
Dietary supplement: Moringa oleifera
12 weeks supplementation
Other Names:
  • Malungay

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Post treatment mean HsCRP
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Post treatment mean hgba1c
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ospital ng Maynila Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rainier Mozo, Dr, Ospital ng Maynila Medical Center Department of Internal Medicine and ICU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Moringa oleifera

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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