| CTRI Number |
CTRI/2018/10/015903 [Registered on: 05/10/2018] Trial Registered Prospectively |
| Last Modified On: |
04/10/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Ph D study |
| Study Design |
Other |
|
Public Title of Study
|
Develop new formula for functional biscuits based on perceptions of students from technical colleges in Mangalore |
|
Scientific Title of Study
|
Evaluate attitudes and behaviours concerning Functional biscuits available in Indian Market as preferred nourishment option and develop new formula for functional biscuits based on perceptions of students from Technical colleges in Mangalore |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kshama Vishwakarma |
| Designation |
Associate Professor |
| Affiliation |
WGSHA Manipal |
| Address |
WGSHA, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
kshama.v@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Asha Kamath |
| Designation |
Professor |
| Affiliation |
MAHE, Manipal |
| Address |
PSPH,MAHE Manipal
MAHE,Manipal
Udupi
KARNATAKA
Kshama Vishwakarma
India |
| Phone |
9611203145 |
| Fax |
|
| Email |
asha.kamath@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Kshama Vishwakarma |
| Designation |
Associate Professor |
| Affiliation |
WGSHA, MAHE, Manipal |
| Address |
WGSHA,MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
kshama.v@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kshama Vishwakarma |
| Address |
MAHE, Manipal |
| 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 |
| Kshama Vishwakarma |
MAHE Manipal |
WGSHA , Madhav nagar,Manipal
Udupi
KARNATAKA |
9611203145
kshama.v@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KHIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Under graduate and post graduate students |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perceptions about branded functional biscuits available in Indian Market |
Two year after registration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="986"
Sample Size from India="986"
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)
|
12/11/2018 |
| 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="4"
Months="0"
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)?
|
|
Brief Summary
|
Seek perceptions about Functional biscuits available in Indian Market To find awareness and acceptability of functional biscuits available presently in Indian Market |