Effect of Moringa Leaf Capsules on Glycemic Control of Type 2 Diabetic Patients- an Interventional Study
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2
Sponsor: Islamabad Medical and Dental College

Cover Page for Protocol  
Sponsor name: Islamabad Medical and Dental college 
NCT number Sponsor trial ID: Not yet assigned 
 Official title of study: Effect of Moringa leaf capsules on glycemic control of Type 2 diabetic patients: A 
Randomized Controlled trial. 
Sponsor trial ID: No 99/IMDDC/IRB-2022 
Document date: 9th January 2023 
 
 
 
 
 
 
 
 
 
Effect of Moringa leaf capsules on glycemic control of Type 2 diabetic 
patients: A Randomized Controlled trial. 

 
Introduction:  
Diabetes mellitus (DM) is one of the most common public health concerns around the globe. It is 
a disorder of carbohydrate metabolism in which blood glucose level is chronically high due to 
insulin's impaired secretion or action. Out of 463 million adults worldwide who suffer from 
diabetes, 90% of these people suffer from type 2 diabetes mellitus. According to the International 
Diabetes Federation, in year 2022, 26.7% of adults in Pakistan are a victim of diabetes mellitus, 
making the total number of cases approximately 33,000,000. (1) 
This alarmingly high number not only poses 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 PKR 80,000. 
Medications accounted for the largest share (60.4%) of this cost. Age, locality, high 
socioeconomic status, and prolonged disease duration were significantly associated with the 
direct costs of illness (p < 0.05). Furthermore, 19% of total earnings among very low-income 
patients were spent on diabetes care. (2)  
According to the World Health Organization (WHO), traditional medicine is defined as “health 
practices, approaches, knowledge and beliefs incorporating plant, animal and mineral based 
medicines, spiritual therapies, manual techniques and exercises, applied singularly or in 
combination to treat, diagnose and prevent illnesses and maintain well-being.” The WHO has 
supported the evaluation of medicinal plants and herbs for the management of certain chronic 
conditions (3) 
In the recent years there has been an exponential growth in the field of herbal medicines and the 
demand of these is increasing both in developing and developed countries because of their 
natural origin, less side effects and low cost. (4)  
The effects of some herbal therapies, such as cinnamon, fenugreek, and milk thistle, on hyperglycemia in 
patients with type 2 diabetes have been investigated in clinical trials, with mixed results. Moringa 
Oleifera, a plant also known as the tree of life or miracle tree, belongs to the genus Moringaceae, which 
is native to the tropics and sub-Himalayan areas of India, Pakistan, Bangladesh, and Afghanistan. The 
immature green pods, also known as drumstick, are consumed in different ways, such as cooking the pods 
(as with green beans) or preparing the leaves like spinach. Along with the glycemic control in diabetes, 
M. oleifera has other medicinal purposes: asthma, hyperlipidemia, hypertension, hormone disorders, and 
gastrointestinal disorders. 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 some 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. (5)  
The leaves are also widely used as vegetable, condiment and in salads. M.Oleifera leaves are 
non-toxic. This has been confirmed by laboratory experiments such as: The aqueous extract of 
M.Oleifera 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. The safety of M.Oleifera leaves has 
been confirmed in other studies (6) 
In different studies, different dosage of M. Oliefera leaf powder capsules have been used. Ten 
healthy volunteers were enrolled in this study , after an overnight fast and every two weeks, 
subjects received an oral dose of MO at increasing dosages of 0, 1, 2, and 4 g. Plasma glucose 
(PG) and insulin were collected at baseline and at 0.5, 1, 1.5, 2, 4, and 6 hours after each MO 
dosage administration and it was scientifically proven that the widely claimed use of M. oleifera 
as an ethno-medicine is useful in treating diabetes mellitus. (7)       
A few human studies are reported on the use of Moringa Oliefera, most of trials are reported on 
animals. In Pakistan no such study is available but people in the rural parts do take it as a myth to 
treat different diseases.  
Rationale:  
Since the studies have shown the effect of Moringa leaves on lowering the blood glucose levels in 
animals and diabetic patients, however, the sufficient investigation has not been done on human 
on large scale to check the effect and their use as an alternative treatment option for diabetic 
patients. Thus, this study is being conducted to assess the effect of Moringa leaf on Diabetics’ 
Glycemic Control. 
Objectives:  
• To assess the combined effect of metformin and Moringa leaf capsules on glycemic control 
of Type 2 diabetic patients. 
• To assess the safety of Moringa leaf capsules in Type-2 Diabetic Patients. 
• To study its effects on blood pressure, BMI, and creatinine levels.   
Hypothesis: 
Moringa Leaf capsules shows positive outcome in lowering the blood glucose levels and is safe 
for Type 2 Diabetic patients.  
Null Hypothesis:  
Moringa Leaf capsules does not have any effect on blood glucose levels and is not safe for Type 
2 Diabetic patients 
Operational Definition: 
Type 2 diabetes: It is characterized by increased fasting plasma glucose ≥126 mg/dL (7.0 mmol/L), 
and HbA1C ≥6.5% (48 mmol/mol) for many nonpregnant adults. (8) 
Glycemic Control: HbA1c level of ≥ 7.0% will be considered as ‘poor glycemic control'. (9) 
Type 2 Diabetic Patients will be divided into two groups based on their HbA1c levels: 
Group A: All the patients with HbA1c < 7.0% 

Group B: All the patients with HBA1c > 7.0%. 
Methodology:  
A randomized controlled trial will be conducted in Akber Niazi Teaching Hospital ANTH. 
Study Duration: 
01 year 
Sample size: 
Confidence interval: 95%  
Ratio of sample size: 1 
Power: 80% 
Mean and Standard Deviation of group 1:  10.07±2.07 
Mean and Standard Deviation of group 2: 8.79±0.10 
Sample size: 42 
As this study is expected for 3 months and the dropout of 20% IS being expected; Therefore, Total sample 
size has been increased to 50. 
Total Sample Size: 50  
Exclusion criteria:  
• Patients having Type I diabetes 
• Pregnant women  
• The patients with deranged LFTs and RFTs. 
• Patients having Creatinine levels more than 1.2 mg/dl in man and >1.1mg/dl in female.(10)  
• Patients of Type II diabetes on insulin therapy 
Inclusion criteria: 
• 
The patients having type 2 diabetes. 
• 
The patients who willingly consent.  
Sampling Technique: 
• 
Random sampling technique will be used to collect the data from type 2 diabetic patients. 
• 
Written informed consent will be taken before any examination. 
• 
Only the researchers will have the excess to the patients’, and it will be kept confidential. 
• 
Pilot testing will be done on 5% of the sample before conducting the whole study. 
Procedure: 

1.A questionnaire consists of diabetic history, demographics, and Anthropometric measure will be 
used for the study.  
2.The questions regarding any side effects will be included in the questionnaire. 
3.Glycated hemoglobin (HbA1c) will be determined by high-performance liquid chromatography. 
4.The patients will be divided into two groups: 
Group A: Having HbA1c <7.0% 
Group B: Patients Having HbA1c >7.0% 
Group A will be further divided into two subgroups, one group will be given metformin and the 
other one will be given Metformin plus Moringa leaf Capsules. 
Similarly, Group B will also be further divided into Two groups, half of the patients will be given 
metformin and the other half will be given metformin plus Moringa leaf Capsules. 
 
 
 
 
 
 
 
 
5. 1g Capsules will be used for the study for 3-month duration in type 2 Diabetic patients. (11) 
6. Fasting Blood glucose levels and HbA1c levels, LFTs, RFTs and lipid profile will be checked 
thrice, before starting the treatment, after ½ month, and at the end of treatment. 
7.To assess the safety of capsules the Lipid function test(LFTs), renal function test(RFTs), and 
lipid profile will be performe. If any value is deranged, the patients will be included in the study. 
Statistical Analysis: 
SPSS version 26 will be used for the analysis. The Continuous variables will be expressed in the 
mean ± SD or median (min, max). Frequencies and percentage will be used for the categorical 
Group A: HbA1c <7.0% 
Group B: HbA1c >7.0% 
Group A1: Metformin  
Group A2: Metformin 
+ Moringa Capsules  
Group B1: Metformin  
Group B2: Metformin 
+ Moringa Capsules  

variables. Finally, Paired T test and One way Anova will be applied to compare before and after 
treatment effects. For analysis, P value < 0.05 will be considered significant.  
Ethical consideration: 
• 
The response forms will be accessible to the study participants only. Thus, their 
information will be kept strictly confidential. 
• 
Sample of informed consent provided in Annexure B. 
• 
No mentionable risks are involved in this study. 
 
Significance:  
• Diabetes is a lifelong disease and researchers are striving to come up with affordable 
options to control diabetes. Thus, this study will help us find an economical way of 
controlling the Type 2 Diabetes. 
• No Side effects of Moringa has been reported to date in any study conducted on animals 
and humans. 
Conflict of interest: There is no conflict of interest to report. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
References:  
 
(1) Azeem S, Khan U, Liaquat A. The increasing rate of diabetes in Pakistan: A silent killer. Annals 
of Medicine and Surgery. 2022 Jul;79. 
(2) 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 review of pharmacoeconomics & outcomes 
research. 2018 Nov 2;18(6):647-53. 

(3) Owens III FS, Dada O, Cyrus JW, Adedoyin OO, Adunlin G. The effects of Moringa oleifera on 
blood glucose levels: a scoping review of the literature. Complementary Therapies in Medicine. 
2020 May 1;50:102362. 
(4) Kumar PK, Mandapaka RT. Effect of moringa oleifera on blood glucose, ldl levels in types ii 
diabetic obese people. Innov. J. Med. Health Sci. 2013;3:23-5. 
(5) Haber SL, McMahon RP, Barajas J, Hayes AR, Hussein H. Effects of Moringa oleifera in patients 
with type 2 diabetes. American Journal of Health-System Pharmacy. 2020 Oct 30;77(22):1834-7. 
(6) Sissoko L, Diarra N, Nientao I, Stuart B, Togola A, Diallo D, Willcox M. Moringa oleifera leaf 
powder for type 2 diabetes: a pilot clinical trial. African Journal of Traditional, Complementary 
and Alternative Medicines. 2020 Nov 18;17(2):29-36. 
(7) 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. Thail. 2016 Mar 1;99:308-13. 
(8) American Diabetes Association. 2. Classification and diagnosis of diabetes: standards of medical 
care in diabetes—2021. Diabetes care. 2021 Jan 1;44(Supplement 1):S15-33. 
(9)  Omar SM, Musa IR, Osman OE, Adam IJBrn. Assessment of glycemic control in type 2 diabetes 
in the Eastern Sudan. 2018;11(1):1-5. 
(10) Shahbaz H, Gupta M. Creatinine clearance. 
(11) Sissoko L, Diarra N, Nientao I, Stuart B, Togola A, Diallo D, Willcox M. Moringa oleifera leaf 
powder for type 2 diabetes: a pilot clinical trial. African Journal of Traditional, Complementary 
and Alternative Medicines. 2020 Nov 18;17(2):29-36. 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANEXURE A: 

Effect of Moringa leaf capsules on glycemic control of Type 2 diabetic 
patients: A Randomized Controlled trial. 
 
General Information 
Name: _______________                                                                                          MR No__________________ 
Age:  _________________ 
Sex:   □    Male                  □    Female                 □    Other 
Date of birth: _____________     
 
 
             Phone number: ____________________ 
Address: 
_____________________________________________________________________________________
_____________________________________________________________________________________ 
City:     ______________                                                                Ethnicity: __________________                     
Marital status:    □ Married     □ Unmarried    □ other               Diabetic:       □ Type 1 □ Type 2 
Height: ___________           
    Weight: _____________                        HbA1c levels: ______________ 
When were you first diagnosed with Diabetes?  
Year: _____________ 
 
                   Age: _____________ 
Medication 
 1. Do you take any medications/pills for your Diabetes?   □ Yes           □ No 
 If yes, please specify the amount and frequency: _____________________________________________ 
2. Are you allergic to any homeopathic medicine?  □ Yes           □ No 
3.Have you ever used the Moringa leafs to control diabetes? □ Yes           □ No 
Before supplementation:  
HbA1c: ___________________                                        Fasting Blood Glucose levels: _________________ 
Systolic Blood Pressure: ______________                     Diastolic Blood Pressure: _____________________ 
Creatinine levels: ___________________                       LFTs: _________________________ 
RFTS: ________________ 
After ½ month:  

HbA1c: ___________________                                         Fasting Blood Glucose levels: _________________ 
Systolic Blood Pressure: ______________                      Diastolic Blood Pressure: _____________________ 
Creatinine levels: ___________________                       LFTs: _________________________ 
RFTS: ________________ 
At the End of Study:  
HbA1c: ___________________                                         Fasting Blood Glucose levels: _________________ 
Systolic Blood Pressure: ______________                      Diastolic Blood Pressure: _____________________ 
Creatinine levels: ___________________                       LFTs: _________________________ 
RFTS: ________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEXURE B: 
Informed Consent form for participation in research ‘Effect of Moringa leaf capsules on glycemic 
control of Type 2 diabetic patients: A Randomized Controlled trial’ 

 
I _______________ confirm that I have read and understood the information shared with me regarding 
the aforementioned topic. 
I understand that my participation is voluntary and I am free to withdraw at any time without giving any 
reason, without my medical and legal rights being affected.                                                                                     
I am aware that my information will be kept confidential. 
I agree to take part in the project which will include being interviewed and recorded.                                       
I have been informed regarding the potential risks that could happen during the study.                                   
 
Patient’s name: ________________                                                    Patient’s signature______________ 
Researcher’s name ______________                                                  Researcher’s signature________