| CTRI Number |
CTRI/2025/10/096545 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing kodo millet diet with regular diabetic diet to manage type 2 diabetes in patients. |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of modified diabetic diet kodo millet diet versus conventional diabetic diet for management oof type 2 diabetic patients Randomized control 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 |
Raghvendra NS |
| Designation |
PhD Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept. of Community Health Nursing, Ground Floor, SRMMCON Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
8073665281 |
| Fax |
|
| Email |
raghavendrasangshetty@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deeplata Mendhe |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept. of Community Health Nursing, Ground Floor, SRMMCON Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9527538397 |
| Fax |
|
| Email |
mendhedeeplata@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deeplata Mendhe |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept. of Community Health Nursing, Ground Floor, SRMMCON Building, Sawangi Meghe
MAHARASHTRA
442001
India |
| Phone |
9527538397 |
| Fax |
|
| Email |
mendhedeeplata@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe, Wardha, India 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Deeplata Mendhe |
Smt Radhikabai Meghe Memorial College of Nursing |
Dept of Community Health Nursing, Ground Floor, SRMMCON Building, Sawangi Meghe
Wardha
MAHARASHTRA |
9527538397
mendhedeeplata@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research Wardha |
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 |
| Comparator Agent |
Conventional diabetic diet |
Conventional diabetic diet will be provided to type 2 diabetic patients for 3 months. |
| Intervention |
Kodo Millet diet |
Kodo millet diet will be provided to Type 2 diabetes patients for 3 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with Type 2 diabetes mellitus
2. Patients coinsenting to participate in study |
|
| ExclusionCriteria |
| Details |
1. Patients below 30 years of age
2. Cases with pregnancy, lactation, liver or kidney diseases |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Better efficacy of Kodo millet diet compared to conventional diet in diabetes control |
Assessment will be done at 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="214"
Sample Size from India="214"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Type 2 diabetes is a modern epidemic in India, and dietary habits affect the mechanism of blood sugar control to a great extent. This study will be a randomized control trial conducted in SRMMCON, Wardha. 214 cases of type 2 diabetes will be randomized into intervention and control arms of 107 each. The intervention group will receive the Kodo Millet diet, whereas the control group will continue the conventional diabetic diet for 3 months. Effecacy of both diets on the management of diabetes control will be compared using appropriate statistical tests. |