FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/093883 [Registered on: 29/08/2025] Trial Registered Prospectively
Last Modified On: 29/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Observational 
Study Design  Other 
Public Title of Study   Making and testing a questionnaire to evaluate immunity power (Ojas) of an individual 
Scientific Title of Study   Development of a standardized assessment tool for evaluating ojas karma: A validation 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 Amit Jangra 
Designation  MD Scholar Department of Kriya Sharir 
Affiliation  Institute for Ayurved Studies and Research, Shri Krishna Ayush University  
Address  OPD no 55A Department of Kriya Sharir Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana 136118 Kurukshetra Haryana 136118 India

Bhiwani
HARYANA
136118
India 
Phone  8168469741  
Fax    
Email  amitjangra0408@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manisha Khatri 
Designation  Associate Professor Department of Kriya Sharir 
Affiliation  Institute for Ayurved Studies and Research, Shri Krishna Ayush University  
Address  Room no 10 Department of Kriya Sharir Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana 136118 Kurukshetra Haryana 136118 India

Kurukshetra
HARYANA
136118
India 
Phone  9416482897  
Fax    
Email  manikhatri79@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manisha Khatri 
Designation  Associate Professor Department of Kriya Sharir 
Affiliation  Institute for Ayurved Studies and Research, Shri Krishna Ayush University  
Address  Room no 10 Department of Kriya Sharir Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana 136118 Kurukshetra Haryana 136118 India

Kurukshetra
HARYANA
136118
India 
Phone  9416482897  
Fax    
Email  manikhatri79@gmail.com  
 
Source of Monetary or Material Support  
Institute for Ayurved Studies and Research, Shri Krishna Ayush University, Umriroad, Sector 8, Kurukshetra, Haryana, India, 136118 
 
Primary Sponsor  
Name  Dr Amit Jangra 
Address  Institute for Ayurved Studies and Research, Shri Krishna Ayush University, Umriroad, Sector 8, Kurukshetra, Haryana, India, 136118  
Type of Sponsor  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 
Dr Amit Jangra  Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana 136118  Opd No 55A Department of Kriya Sharir Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana 136118 Kurukshetra HARYANA
Kurukshetra
HARYANA 		 8168469741

amitjangra0408@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy individuals 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Participants between the age group of 18 and 40 years.
The study population will consist of healthy participants.
Willing to participate in study with consent.  
 
ExclusionCriteria 
Details  Individuals below the age of 18 years and above the age of 40 years.
Patient not willing to participate in the trial.
K/C/O Diabetes mellitus, hypertension, hyper or hypothyroidism, hemiplegia, epilepsy,
Autoimmune disorders and any other chronic illness.
Pregnant women and Lactating mothers.
History of any Major surgery in the recent past.
History of Prolonged steroid medicine intake.
History of Alcohol intake & Smoking.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Development of a Structured Ojas karma Assessment Questionnaire
representing physical, psychological, and lifestyle indicators of Ojas, systematically derived from
classical Ayurvedic texts and expert clinical experience.
Content Validity of the Tool assessed by Degree to which the items are relevant and representative
of the concept of Ojas karma, as judged by expert consensus.
Face Validity of the Tool assessed by the Degree to which the tool appears appropriate and
comprehensive for assessing Ojas karma from the perspective of domain experts.
[Qualitative consensus and percentage agreement among experts regarding clarity, coverage,
and representativeness.] 		 Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Internal Consistency (Reliability) assessed through obtaining Consistency of responses
Test-Retest Reliability by demonstrating Stability of the tool over time in a stable population. 		 Baseline 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   14/09/2025 
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="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   The tool development process involves several structured stages to ensure accuracy and reliability. First, item generation is carried out through an extensive literature review, followed by thematic categorization and drafting of initial items. Next, content and face validity are established by forming an expert panel to evaluate clarity, relevance, and comprehensiveness, including calculation of the Content Validity Index (CVI). A pilot test is then conducted with an appropriate sample to assess comprehension, usability, and refine items as needed. Reliability is examined through internal consistency and test–retest methods. Finally, a scoring scheme and cut-off points are determined for categorization, and the finalized tool is documented for use. 
Close