| CTRI Number |
CTRI/2025/11/097485 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
17/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Meal Sequencing (Based on Rasa) on Blood Sugar Levels in Healthy Adults |
|
Scientific Title of Study
|
A Comparative Study to Assess the Effect of Meal Sequencing Based on rasa Order on Glycemic Response in Healthy Adults: An Exploratory, Single-Arm Interventional Study. |
| Trial Acronym |
YES |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nandini Ray Mohapatra |
| Designation |
PG Scholar |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
6th Floor Room no. 622 Department Of Swasthavritta All India
Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi South DELHI 110076 India
South
DELHI
110076
India
South DELHI 110076 India |
| Phone |
9090562755 |
| Fax |
|
| Email |
nandini14243@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shivakumar S Harti |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
6th Floor Room no. 602 Department Of Swasthavritta All India
Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi South DELHI 110076 India
South
DELHI
110076
India
South DELHI 110076 India |
| Phone |
9611275434 |
| Fax |
|
| Email |
shivakumarsharti@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shivakumar S Harti |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
6th Floor Room no. 602 Department Of Swasthavritta All India
Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi South DELHI 110076 India
South
DELHI
110076
India
DELHI 110076 India |
| Phone |
9611275434 |
| Fax |
|
| Email |
shivakumarsharti@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF AYURVEDA |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Ayurveda |
| Address |
All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi 110076 |
| Type of Sponsor |
Government 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 Shiva kumar S Harti |
All India Institute Of Ayurveda |
6th Floor Room no. 622 Department Of Swasthavritta All India
Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi South DELHI 110076 India
South
DELHI
110076
India South DELHI |
9611275434
shivakumarsharti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee of All India Institute Of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy volunteers with age between 25-30 years, irrespective of sex, caste and religion.
2. BMI, 18.5-24.9 kg/m2
3. Participants who are willing to participate. |
|
| ExclusionCriteria |
| Details |
1. Individuals with diagnosed diabetes or pre-diabetes, cardiovascular disease, and cancer.
2. Diseases of the digestive system or any other severe disease.
3. Pregnant and lactating women.
4. Individuals having food allergy or intolerance (to reduce the risk of adverse reactions after
consuming the test meals), metabolic conditions or use of medications or nutritional
supplements known to affect glucose metabolism, medications that may affect carbohydrate
metabolism.
5. Subjects would be excluded if they reported a history of gastrointestinal disorders, suffered
from diabetes, taking medication for any chronic disease conditions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Postprandial Glycemic Response (PPGR)
• Parameter: Capillary blood glucose (CBG)
• Time Intervals:
• 0 min (fasting), 30 min, 60 min, 90 min and 120 min post-meal
• Method:
20
• Glucometer-based capillary glucose monitoring |
• Time Intervals:
• 0 min (fasting), 30 min, 60 min, 90 min and 120 min post-meal
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Jeerna ahara lakshana
udgara shuddhi, laghuta , kshudha |
any one of the above lakshana , which appears first post meal. |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 assess the effect of meal sequencing based on rasa on post prandial glycemic response in healthy adults.
In this study, healthy adult volunteers will be provided with a designed meal, based on rasa.
Capillary blood glucose will be measured at defined intervals to assess the glycemic response.
This study is going pave ways for further research in the same arena. |