| CTRI Number |
CTRI/2024/07/070127 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Study the Glycaemic Index of New rice and New Roasted rice |
|
Scientific Title of Study
|
Study the Glycaemic Index of Different Types of Shalee (Navanna and Navanna Bharjeet) in Healthy Individuals : A Clinical Study |
| 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 Anjali Dadaji Turale |
| Designation |
PhD Scholar |
| Affiliation |
Yashwant Ayurvedic College P.G. Training and Research centre kodoli, Kolhapur |
| Address |
Swasthavritta Dept.,Yashwant Ayurvedic College P.G. Training and Research centre kodoli,Tal. Panhala. Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9623444069 |
| Fax |
|
| Email |
dr.anjaliturale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Milind M. Godbole |
| Designation |
Professor and Head |
| Affiliation |
Yashwant Ayurvedic College P.G. Training and Research centre kodoli, Kolhapur |
| Address |
Swasthavritta Dept.,Yashwant Ayurvedic College P.G. Training and Research centre kodoli,Tal. Panhala. Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9850119900 |
| Fax |
|
| Email |
drmilindgodbole@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Milind M. Godbole |
| Designation |
Professor and Head |
| Affiliation |
Yashwant Ayurvedic College P.G. Training and Research centre kodoli, Kolhapur |
| Address |
Swasthavritta Dept.,Yashwant Ayurvedic College P.G. Training and Research centre kodoli,Tal. Panhala. Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9850119900 |
| Fax |
|
| Email |
drmilindgodbole@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College, Post Graduate Training and Research centre,Kodoli, Kolhapur. |
|
|
Primary Sponsor
|
| Name |
Dr Anjali Turale |
| Address |
Swasthavritta Dept., Yashwant Ayurvedic College, P. G. Training and Research Centre,Kodoli,Kolhapur-416114 |
| 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 Anjali Turale |
Yashwat Ayurvedic College, Kodoli |
Swasthavritta Dept.,Yashwant Ayurvedic College P.G. Training and Research centre kodoli,Tal. Panhala. Dist Kolhapur
Kolhapur
MAHARASHTRA |
9623444069
dr.anjaliturale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yashwant Ayurvedic college,Kodoli,Kolhapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Age group between 30 to 60 years |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Cooked new rice and new roasted rice, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Healthy individuals of age group between 30 to 60 years of both sex with no other any systemic disorder will be taken |
|
| ExclusionCriteria |
| Details |
Healthy individuals of age group less than 30 and more than 60 years of both sex with any systemic disorder will not be taken |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to know the difference of glycaemic index of new rice and new roasted rice |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevention of Lifestyle disorder by knowing the GI of Rice, as it the staple food of India |
3 months |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 |
|
Date of First Enrollment (India)
|
22/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The incidence of diabetes, a chronic metabolic
disorder with multiple etiologies, obesity, CVS diseases is characterized by sustained high levels of
blood sugar. About 422 million people are affected with this disease world-wide
(WHO, 2016) India is among the worst affected countries with 69.2 million diabetic people
accounting for 8.7% of total diabetic population worldwide India is the second largest producer of rice in
the world and it is main staple food of Indian diet. High consumption of rice which is considered to
be food with high glycemic potential was found to be associated with increased
risk of type II diabetes . In present study researcher trying to know about the difference between Glycemic index of new rice and new roasted rice as as high GI food causes diabetes , obesity and CVS. Study duration for this study is 3 months, Sample size is 48. Statistical test will be applied and result will be analyzed accordingly. |