FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/077069 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 01/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   QUESTIONNAIRE INSTRUMENT DEVELOPMENT STUDY 
Study Design  Other 
Public Title of Study   Development and Validation of Ojas analysis tool:A study on creating and verifying a questionnaire for health assessment 
Scientific Title of Study   Development validation and verification of Ojas analysis tool: A questionnaire instrument development 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  DrSukanya Nagesh Bhat 
Designation  PG Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara college of Ayurveda, Hospital and Research centre,Kuthpady, Udupi 
Address  Shri Dharmasthala Manjunathehwara College of Ayurveda,Hospital and Research centre Kuthpady Udupi, 574118, karnataka

Udupi
KARNATAKA
574118
India 
Phone  9686909304  
Fax    
Email  sukanyabhat70@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,Kuthpady, Udupi 
Address  Sri Dharmasthala Manjunatheshwara college of Ayurveda, Hospital and Research centre,Kuthpady, Udupi

Udupi
KARNATAKA
574118
India 
Phone  9686909304  
Fax    
Email  deshushetty@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrSukanya Nagesh Bhat 
Designation  PG Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara college of Ayurveda, Hospital and Research centre,Kuthpady, Udupi 
Address  Shri Dharmasthala Manjunatheshwara College of Ayurveda,Hospital and Research Centre Kuthpady Udupi, 574118, karnataka

Udupi
KARNATAKA
574118
India 
Phone  9686909304  
Fax    
Email  sukanyabhat70@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara college of Ayurveda, Hospital and research centre, Kuthpady, Udupi 
 
Primary Sponsor  
Name  DrSukanya Nagesh Bhat 
Address  Sri Dharmasthala Manjunatheshwara college of Ayurveda, Hospital and research centre, Kuthpady, Udupi 
Type of Sponsor  Other [Other [self]] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSukanya Bhat  Sri Dharmasthala Manjunatheshwara college of Ayurveda,Hospital,Research centre  Department of PG Studies in Swasthavritta Sri Dharmasthala Manjunatheshwara college of Ayurveda,Hospital,Research centre, Kuthpady Udupi, 574118, karnataka
Udupi
KARNATAKA 
9686909304

sukanyabhat70@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL CLEARANCE COMMITTEE-HUMAN  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy human volunteers 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Literate subjects
2.both gender
3.Subjects with varying spectrum of health status 
 
ExclusionCriteria 
Details  1.Subjects who are unable to respond to questionnaire
2.Non-cooperative
3.With psychiatric illness 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The lacuna of tool to assess status of Ojas is filled by this questionnaire  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Developed and validated questionnaire can be used to assess the status of individuals and for further research studies  6 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/12/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
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
Modification(s)  
This study aims to develop and validate a questionnaire to assess the status of Ojas, a concept in Ayurveda. The research begins with an exploration of Ojas through Ayurvedic literature. A preliminary questionnaire will be created based on this exploration and will be tested among four focus groups: Ayurvedic academicians, practitioners, individuals who have undergone Ayurvedic treatment, and healthy individuals without Ayurvedic knowledge. The feedback will be analyzed to refine the questionnaire, which will then be administered to a larger sample of 500 respondents.

The study will use stratified cluster sampling, including literate participants of any gender with varying health statuses. Exclusions will include those unable to respond, non-cooperative individuals, and those with psychiatric illnesses. The questionnaire will contain both multiple-choice and open-ended questions, allowing respondents to explain their answers, and will also collect demographic information. 

The content validity of the questionnaire will be ensured by review from Ayurvedic experts, while face validity will be tested with the general public for clarity. Construct validity will be assessed using factor analysis, with a KMO coefficient above 0.7 considered acceptable. The reliability of the questionnaire will be tested using Cronbach’s Alpha, and items with low correlation may be removed. The final questionnaire will be distributed to 500 subjects, and data will be analyzed using statistical methods to compare responses between healthy and unhealthy individuals. The study aims to create a reliable tool for assessing Ojas, enhancing the understanding and application of Ayurvedic health concepts.
 
Close