Brief Summary

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P25-P50 for phase_2 diabetes-mellitus-type-2

Timeline

Completed

Started Mar 2023

Typical duration for phase_2 diabetes-mellitus-type-2

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.4 years study duration

Study Start

First participant enrolled

March 15, 2023

Completed

14 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2023

Completed

8 months until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed

Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

March 29, 2023

Last Update Submit

November 5, 2023

Conditions

Diabetes Mellitus Type 2

Keywords

Diabetes Mellitus Type 2Moringa Leaf powderSide effects

Outcome Measures

Primary Outcomes (2)

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

Secondary Outcomes (3)

Moringa leaf powder effect on Systolic Blood Pressure
3 months
Moringa leaf powder effect on Diastolic Blood Pressure
3 months
Moringa leaf powder effect on body weight of patients
3 months

Study Arms (2)

Metformin

ACTIVE COMPARATOR

Metformin 500mg taken orally twice daily

Drug: Metformin

"Moringa+Metformin"

EXPERIMENTAL

Metformin 500mg taken orally twice daily with Moringa Oliefera (MO) capsule 1g once daily before breakfast

Drug: Metformin

Interventions

MetforminDRUG

Moringa + Metformin - Moringa 1 gm and Metformin 500 mg

Also known as: Metformin is a glucose-lowering drug by inhibiting hepatic gluconeogenesis and opposing the action of glucagon.

"Moringa+Metformin"Metformin

Eligibility Criteria

Age40 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

The patients who willingly consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Islamabad Medical and Dental Collegelead

Study Sites (1)

Islamabad Medical and Dental College

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (8)

American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S15-S33. doi: 10.2337/dc21-S002.
PMID: 33298413BACKGROUND
Azeem S, Khan U, Liaquat A. The increasing rate of diabetes in Pakistan: A silent killer. Ann Med Surg (Lond). 2022 Jun 3;79:103901. doi: 10.1016/j.amsu.2022.103901. eCollection 2022 Jul. No abstract available.
PMID: 35860160RESULT
Gillani AH, Aziz MM, Masood I, Saqib A, Yang C, Chang J, Mohamed Ibrahim MI, Fang Y. Direct and indirect cost of diabetes care among patients with type 2 diabetes in private clinics: a multicenter study in Punjab, Pakistan. Expert Rev Pharmacoecon Outcomes Res. 2018 Dec;18(6):647-653. doi: 10.1080/14737167.2018.1503953. Epub 2018 Aug 1.
PMID: 30052085RESULT
Owens FS 3rd, Dada O, Cyrus JW, Adedoyin OO, Adunlin G. The effects of Moringa oleifera on blood glucose levels: A scoping review of the literature. Complement Ther Med. 2020 May;50:102362. doi: 10.1016/j.ctim.2020.102362. Epub 2020 Feb 28.
PMID: 32444043RESULT
Haber SL, McMahon RP, Barajas J, Hayes AR, Hussein H. Effects of Moringa oleifera in patients with type 2 diabetes. Am J Health Syst Pharm. 2020 Oct 30;77(22):1834-1837. doi: 10.1093/ajhp/zxaa255. No abstract available.
PMID: 32960218RESULT
Anthanont P, Lumlerdkij N, Akarasereenont P, Vannasaeng S, Sriwijitkamol A. Moringa Oleifera Leaf Increases Insulin Secretion after Single Dose Administration: A Preliminary Study in Healthy Subjects. J Med Assoc Thai. 2016 Mar;99(3):308-13.
PMID: 27276742RESULT
Omar SM, Musa IR, Osman OE, Adam I. Assessment of glycemic control in type 2 diabetes in the Eastern Sudan. BMC Res Notes. 2018 Jun 8;11(1):373. doi: 10.1186/s13104-018-3480-9.
PMID: 29884216RESULT
Shahbaz H, Rout P, Gupta M. Creatinine Clearance. 2024 Jul 27. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK544228/
PMID: 31334948RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

Yasiri Niazi, MD
IMDC
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: SUPPORTIVE CARE
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor and Head of Department

Study Record Dates

First Submitted

March 29, 2023

First Posted

November 9, 2023

Study Start

March 15, 2023

Primary Completion

May 1, 2024

Study Completion

August 1, 2024

Last Updated

November 9, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing: Will not share

Locations

PA(1)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (2)

Metformin

"Moringa+Metformin"

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (8)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (2)

Metformin

"Moringa+Metformin"

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (8)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations