Effect of Moringa Leaf Capsules on Glycemic Control of Type 2 Diabetic Patients
NCT ID: NCT06125873
Last Updated: 2023-11-09
Study Results
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Basic Information
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ENROLLING_BY_INVITATION
PHASE2
50 participants
INTERVENTIONAL
2023-03-15
2024-08-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Metformin
Metformin 500mg taken orally twice daily
Metformin
Moringa + Metformin - Moringa 1 gm and Metformin 500 mg
"Moringa+Metformin"
Metformin 500mg taken orally twice daily with Moringa Oliefera (MO) capsule 1g once daily before breakfast
Metformin
Moringa + Metformin - Moringa 1 gm and Metformin 500 mg
Interventions
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Metformin
Moringa + Metformin - Moringa 1 gm and Metformin 500 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
40 Years
70 Years
ALL
No
Sponsors
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Islamabad Medical and Dental College
OTHER
Responsible Party
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Professor Dr. Asma Irfan
Professor and Head of Department
Principal Investigators
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Yasiri Niazi, MD
Role: STUDY_DIRECTOR
IMDC
Locations
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Islamabad Medical and Dental College
Islamabad, Federal, Pakistan
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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/
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Related Links
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Type2 diabetes and moringa
Other Identifiers
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No 99/IMDDC/IRB-2022
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
imdc123
Identifier Type: -
Identifier Source: org_study_id
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