| CTRI Number |
CTRI/2025/10/096727 [Registered on: 31/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Preparing and testing a convenient ready-to-cook Ayurvedic meal for type 2 diabetes mellitus |
|
Scientific Title of Study
|
Development and comparative clinical study of a convenient ready to cook antidiabetic meal using Pramehahara Dravyas in the management of type 2 diabetes mellitus |
| 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 K Shreeraksha |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre, Udupi |
| Address |
Department of Swasthavritta,
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital & Research Centre, Kuthpady, Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9482938525 |
| Fax |
|
| Email |
kshreeraksha99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandesh Kumar |
| Designation |
Associate Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre, Udupi |
| Address |
Department of PG Studies in Swasthavritta and Yoga,
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital & Research Centre, Kuthpady, Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9844884424 |
| Fax |
|
| Email |
deshushetty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Shreeraksha |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre, Udupi |
| Address |
Department of Swasthavritta,
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital & Research Centre, Kuthpady, Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9482938525 |
| Fax |
|
| Email |
kshreeraksha99@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr K Shreeraksha |
| Address |
Department of Swasthavritta,
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital & Research Centre, Kuthpady, Udupi, 574118 |
| Type of Sponsor |
Other [Self] |
|
|
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 K Shreeraksha |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi |
OPD-8
Departmet of Kayachikitsa
OPD-13
Department of Swasthavritta and Yoga
Udupi
KARNATAKA |
9482938525
kshreeraksha99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Dharmasthala Manjunatheshwara College of Ayurveda Udupi Institutional Ethical Clearance Committee- humans |
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. Ayurveda Condition: PRAMEHAH, (2) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: Regular exercise, active lifestyle, avoidance of day-sleep, Ritucarya: Nothing specific, Acara Rasayana:Nothing specific, Other:Newly developed ready-to-cook meal will be advised for lunch and dinner for at least 4 days a week for 8 weeks , Pathya/Apathya:yes, Pathya:Freshly prepared light-to-digest foods, fenugreek seeds, use of whole grains, bitter gourd, buttermilk, , Apathya:Sweets, bakery products, fried foods, fast foods, carbonated drinks, potatoes, banana, chikkoo | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nishamalaki vati, Reference: Ashtanga Hridayam, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of age group of 18 to 45 newly diagnosed cases of type 2 diabetes mellitus with HbA1c between 5.7 and 7.5 per cent |
|
| ExclusionCriteria |
| Details |
1. Any systemic illness which hampers the outcome of the study
2. Pregnant women and lactating mothers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. A ready to cook Ayurvedic meal for diabetes mellitus will be developed.
2. The effect of the ready to cook Ayurvedic anti diabetic meal in the management of type 2 Diabetes mellitus will be identified.
3. The nutritive value of the developed ready to cook Ayurvedic anti diabetic meal will be assessed.
|
Subjective and objective criteria will be assessed at baseline, 4 weeks & 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
02/12/2025 |
| 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="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kshreeraksha99@gmail.com].
- For how long will this data be available start date provided 15-11-2025 and end date provided 15-11-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Diabetes is an iceberg disease. Although increase in both the prevalence and incidence of type 2 diabetes have occurred globally they have been especially dramatic in societies in economic transition in newly industrialized countries and in developing countries. In the fast evolving urban lifestyle where people do not have enough time to prepare healthy foods every day the demand for ready to cook foods is rising. Most of the people with diabetes come under this category. Thus in the era of fast food and preserved food items it is the need of the hour to come up with Ready to Cook Rice Meal for Diabetes incorporating the Ayurvedic principles told for diabetes. A ready to cook meal free from all kinds of preservatives freshly prepared in a short duration of time can become a very convenient go to meal. This rice meal is incorporated with Pramehahara ingredients told in Ayurveda and is enriched with the required nutrients for a diabetes patient. The present study is a single blind controlled comparative study with pre test and post test design which aims at developing a ready to cook ayurvedic antidiabetic meal and comparing its efficacy with already existing medicine for diabetes which is Nishamalaki Vati. A total of 30 patients diagnosed with type 2 diabetes mellitus will be selected fulfilling inclusion criteria for the study after subjecting them to thorough clinical examination as per the proforma prepared for the study irrespective of gender religion and socioeconomic status. 30 newly diagnosed patients of type 2 diabetes mellitus selected as per the inclusion criteria will be randomly allocated in Group A and Group B. Group A will receive the ready to cook Ayurvedic anti diabetic meal twice daily for a period of 8 weeks and Group B will receive Nishamalaki Vati 500mg twice daily for a period of 8 weeks. Duration of the study will be 8 weeks for both groups. Follow up on 4th week during the study. Objectives of the study include 1. Development of ready to cook Ayurvedic meal for diabetes mellitus. 2. To study the effect of the ready to cook Ayurvedic anti-diabetic meal in the management of type 2 Diabetes mellitus. 3. To study the nutritive value of the developed ready to cook Ayurvedic anti diabetic meal. |