| CTRI Number |
CTRI/2024/01/061527 [Registered on: 16/01/2024] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Other (Specify) [Natural leaf juice ] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of moringa leaves on type 2 Diabetes mellitus |
|
Scientific Title of Study
|
Effect of Moringa Oleifera leaves juice on random blood glucose level among patients with type 2 Diabetes mellitus - A Prospective Randomised Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gaurav Pathak |
| Designation |
Post graduate scholar |
| Affiliation |
Maharishi Aurobindo Subharti College & Hospital of Naturopathy & Yogic Sciences |
| Address |
Postgraduate Scholar Room, Maharishi Aurobindo Subharti College & Hospital of Naturopathy & Yogic Sciences
Swami Vivekanand Subharti University Subhartipuram,NH-58,Delhi-Haridwar Bypass Road, Meerut
Subhartipuram, NH-58, Delhi- Haridwar highway, Meerut-250005
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7376895100 |
| Fax |
|
| Email |
gaurav.pathak5100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nair Dhiren Ajit |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Aurobindo Subharti College & Hospital of Naturopathy & Yogic Sciences |
| Address |
Department of Postgraduate Studies, Maharishi Aurobindo Subharti College & Hospital of Naturopathy & Yogic Sciences
Swami Vivekanand Subharti University Subhartipuram,NH-58,Delhi-Haridwar Bypass Road, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7899143619 |
| Fax |
|
| Email |
danny.a.nair@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay M. Shankaregowda |
| Designation |
Principal |
| Affiliation |
Maharishi Aurobindo Subharti College & Hospital of Naturopathy & Yogic Sciences |
| Address |
Principal Office, Maharishi Aurobindo Subharti College & Hospital of Naturopathy & Yogic Sciences
Swami Vivekanand Subharti University Subhartipuram,NH-58,Delhi-Haridwar Bypass Road, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9448300347 |
| Fax |
|
| Email |
naturopathy@subharti.org |
|
|
Source of Monetary or Material Support
|
| Dr. Gaurav
Self-Financed, Swami Vivekanand Subharti University & Chhatrapati Shivaji Subharti Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Gaurav Pathak |
| Address |
Swami Vivekanand Subharti University Subhartipuram,NH-58,Delhi-Haridwar Bypass Road, Meerut |
| Type of Sponsor |
Other [Self sponsored ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gaurav Pathak |
Department of General Medicine Chhatrapati Shivaji Subharti Hospital |
Subhartipuram, NH-58 Delhi- Haridwar Highway, Meerut - 250005, Uttar Pradesh
Meerut
UTTAR PRADESH |
7376895100
gaurav.pathak5100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UECM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MORINGA OLEIFERA LEAVE JUICE |
Fresh moringa juice prepared from 50gm fresh moringa leaves with 100ml of drinking water was administered to recruited patients with type 2 diabetes of random serum glucose 200 mg/dL or 11.1 mmol/L. Blood samples were collected in plain tubes before (-5 minutes) and at 30 and 60 minutes after drinking moringa juice. Blood samples were centrifuged and serum was collected and stored for glucose analysis. Moringa leaves were separated by hand, and fresh moringa juice was prepared by mixing the leaves with 100ml water using a juicer.
The overall Duration required for the intervention and sample collection is 1 hour. |
| Comparator Agent |
Standard Care
|
Standard hypoglycaemic drug which was referred to patient.
The overall Duration required for the intervention and sample collection is 1 hour. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
PATIENT WILLING TO PARTICIPATE
KNOWN CASE OF DIABETES FOR MORE THAN 1 YEAR |
|
| ExclusionCriteria |
| Details |
On insulin injections
Known case of diabetes for less than one year
Pregnant
Lactating
Menstruating
Chronic renal disease
Autoimmune diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Random Blood Sugar(RBS) |
Baseline and after 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Systolic Blood Pressure & Diastolic Blood Pressure |
Baseline & at 30 minutes |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/02/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to conduct a prospective randomized controlled trial on individuals diagnosed with type II diabetes mellitus. The objective is to assess the impact of consuming fresh moringa leaves (50gm) juice on random blood glucose levels. These leaves have been recognized as effective hypoglycemic agents; however, no randomized controlled trial has been conducted among the Indian population to date, specifically utilizing random blood glucose levels, as well as systolic and diastolic blood pressure as secondary outcomes of the study. The null hypothesis states that there is no correlation between the consumption of moringa leaf juice and random blood glucose levels among individuals with type II diabetes. Conversely, the alternative hypothesis suggests that there is indeed a relationship between the consumption of moringa leaf juice and random blood glucose levels among individuals with type II diabetes. |