Effect of Moringa Leaf Capsules on Glycemic Control of Type 2 Diabetic Patients

November 5, 2023 updated by: Professor Dr. Asma Irfan, Islamabad Medical and Dental College

Effect of Moringa Leaf Capsules on Glycemic Control of Type 2 Diabetic Patients- an Interventional Study

A randomized clinical trial will be done on 50 patients , randomly divided into two groups by lottery method to compare the glycemic control in patients of Type 2 Diabetes Mellitus by the use of Moringa Oleifera (MO) capsules. Patients will be given Moringa Oleifera (MO) capsules for 3 months and follow up will be conducted after 3 months to assess glycemic control.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Few human studies are reported on Moringa Oleifera (MO), with most trials reported on animals. Based on human studies, the plant has been proposed to decrease glucose levels by increasing insulin secretion and sensitivity and by inhibiting amylase and glucosidase activities proven by animal studies, additional proposed mechanisms of action include increased glucose uptake in the muscle and liver, inhibition of glucose uptake in the intestine, and decreased gluconeogenesis in the liver.

Rationale of this study is to observe the effects of Moringa Oleifera (MO) capsules, a herbal medicine, on lowering Hba1c levels and compare it with the first line drug so that it can be recommended in the guidelines as a supportive treatment option.

A few human studies are reported on the use of Moringa Oleifera (MO), most of trials are reported on animals. In Pakistan no such study is available but people in rural areas take it as a myth to treat different diseases.

Moringa Oleifera (MO) leaves are non-toxic. This has been confirmed by laboratory experiments such as The aqueous extract of leaves was administered orally to 30 male Wistar rats and even in doses of 2000 mg/kg no mortality ensued. Sub-acute toxicity was assessed by administering daily doses of up to 1600 mg kg to male rats, and no signs of serious toxicity were observed on biochemical or haematological tests, or on histopathology of the organs.

According to the International Diabetes Federation, in the year 2022, 26.7% of adults in Pakistan are a victim of diabetes mellitus, making the total number of cases approximately 33,000,000. This alarmingly high number poses not only an enormous risk of health complications but also a huge financial load on patients. A substantial proportion of patients' income is spent on diabetes care. The mean annual direct cost per patient with diabetes was estimated to be 80,000 Rupees. Medications accounted for the largest share (60.4%) of this cost. The WHO has supported the evaluation of medicinal plants and herbs for the management of certain chronic conditions. In recent years there has been exponential growth in the field of herbal medicines and the demand for these is increasing both in developing and developed countries because of their natural origin, fewer side effects and low cost.

The objective of this study is to assess the combined effect of metformin and Moringa Oleifera (MO) capsules on the participants of glycaemic control (Type 2 diabetics), the safety of Moringa Oleifera (MO) capsules by measuring the partcipant's Liver function tests(LFTs) and Renal function tests(RFTs). HbA1c level of ≥ 7.0% will be considered as 'poor glycemic control'.

Pilot testing will be done on 5% of the sample before conducting the whole study.Informed written consent will be taken from the enrolled patients and confidentiality will be maintained throughout the study. A detailed history will be taken focusing on duration and onset, family history, lifestyle and daily activities. Liver Function Tests and Renal Function Tests will be assessed. A questionnaire attached will be used by the investigators for taking participant's history, anthropometric measures, and demographic details. Data will be collected under the supervision of a diabetic specialist. Particpants will be requested to visit ANTH hospital every month to get their lab investigations done and to report side effects if any. Glycated haemoglobin (HbA1c) will be determined by high-performance liquid chromatography before and at the end of the study by a skilled Lab technician in (ANTH). Fasting blood glucose levels will be measured by a glucometer and participants will also be instructed and guided on the first visit to use a glucometer to check and note daily fasting glucose levels. The questions regarding any side effects are included in the questionnaire. There will be no potential risk to the patient, as monitoring of RFTs, LFTs, and Lipid profiles will be done every month. If lab reports are deranged on participant's first visit to the hospital, participant will be excluded from the study. Random distribution of patients will be done through lottery method. Group A will be treated with Tablet Metformin 500mg twice a day and group B with Moringa Oleifera (MO) capsules along with patients usual dose of Tablet Metformin. All the patients will be advised to have proper diet control and lifestyle modifications.

The data will be analyzed with the help of Statistical Package for Social Sciences (SPSS) version 25. Chi-square test will be applied to compare the clinical efficacy, and safety in terms of any side effect between both groups throughout the study period. P-value of <0.05 will be considered significant.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Federal
      • Islamabad, Federal, Pakistan, 44000
        • Islamabad Medical and Dental College

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:• The patients of over age 40 with type 2 diabetes

  • The patients who willingly consent

Exclusion Criteria:• Patients having Type I diabetes

  • Pregnant women
  • The patients with deranged LFTs and RFTs.
  • Patients having Creatinine levels more than 1.3 mg/dl in man and >1.1mg/dl in female.
  • Patients of Type II diabetes on insulin therapy

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Metformin
Metformin 500mg taken orally twice daily
Drug: Metformin
Moringa + Metformin - Moringa 1 gm and Metformin 500 mg
Other Names:
  • Metformin is a glucose-lowering drug by inhibiting hepatic gluconeogenesis and opposing the action of glucagon.
Experimental: "Moringa+Metformin"
Metformin 500mg taken orally twice daily with Moringa Oliefera (MO) capsule 1g once daily before breakfast
Drug: Metformin
Moringa + Metformin - Moringa 1 gm and Metformin 500 mg
Other Names:
  • Metformin is a glucose-lowering drug by inhibiting hepatic gluconeogenesis and opposing the action of glucagon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Moringa leaf powder decreases blood sugar level in type 2 diabetic patients.
Time Frame: 3 months
Fasting blood glucose tested after 15 days regularly.
3 months
It controls blood Glycated hemoglobin level in type 2 diabetic patients.
Time Frame: 3 months
Glycated Hemoglobin(Hb A1c) tested after 3 months.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Moringa leaf powder effect on Systolic Blood Pressure
Time Frame: 3 months
Systolic BP will be measured in mm Hg at the start of study and then after every 3 months
3 months
Moringa leaf powder effect on Diastolic Blood Pressure
Time Frame: 3 months
Diastolic BP will be measured in mm Hg at the start of study and then after every 3 months
3 months
Moringa leaf powder effect on body weight of patients
Time Frame: 3 months
The weight in kg at the start of study and then after every 3 months
3 months

Collaborators and Investigators

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

Sponsor

Islamabad Medical and Dental College

Investigators

  • Study Director: Yasiri Niazi, MD, IMDC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

March 15, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria

November 5, 2023

First Posted (Estimated)

November 9, 2023

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 5, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • imdc123
  • No 99/IMDDC/IRB-2022 (Other Grant/Funding Number: IMDC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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