| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
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. |