| CTRI Number |
CTRI/2024/03/064588 [Registered on: 21/03/2024] Trial Registered Prospectively |
| Last Modified On: |
20/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Tool Development |
| Study Design |
Other |
|
Public Title of Study
|
Unveiling a Novel Tool for Assessing Deha Prakriti(body constitution)in Children and Adolescents - Development and Validation Journey |
|
Scientific Title of Study
|
Development and Validation of tool for assessment of deha prakriti(Body constitution) in children and Adolescents. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meera K Bhojani |
| Designation |
Associate Professor |
| Affiliation |
All India institute of Ayurveda |
| Address |
All India institute of Ayurveda
Department of Kriya Sharira
Gautampuri Awas Badarpur
New Delhi 110044
South
DELHI
110044
India |
| Phone |
09971646889 |
| Fax |
|
| Email |
meera.samhita@aiia.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Muskan Parveen |
| Designation |
MD Scholar |
| Affiliation |
All India institute of Ayurveda |
| Address |
All India institute of Ayurveda
Department of Kriya Sharira
Gautampuri Awas Badarpur
New Delhi 110044
DELHI
110019
India |
| Phone |
09971646889 |
| Fax |
|
| Email |
muskanalvishah6262@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Muskan Parveen |
| Designation |
MD Scholar |
| Affiliation |
All India institute of Ayurveda |
| Address |
All India institute of Ayurveda
Department of Kriya Sharira
Gautampuri Awas Badarpur
New Delhi 110044
DELHI
110044
India |
| Phone |
09971646889 |
| Fax |
|
| Email |
muskanalvishah6262@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India institute of Ayurveda |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
NH 19 GAUTAMPURI AWAS SARITA VIHAR NEW DELHI 110076 |
| Type of Sponsor |
Government medical college |
|
|
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 Muskan Parveen |
All India institute of Ayurveda |
All India institute of Ayurveda
Department of Kriya Sharira
Gautampuri Awas Badarpur
New Delhi 110044
South
DELHI |
09971646889
muskanalvishah6262@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Division of Translation Research And Biostatistics |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
age group 1-18 years of both sexes who are willing to consent ad are apparently healthy. |
|
| ExclusionCriteria |
| Details |
Individuals having a history of some physical disorders, personality
disorder or medically ill in any way or unwilling to participate. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of deha prakriti(Body constitution)of children and Adolescents by the development of Tool. |
18 months required for Assessment of deha prakriti(Body constitution)of children and Adolescents by the Tool. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
01/04/2024 |
| 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)
|
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
|
METHODOLOGY Tool Development Process :- Conceptual & Fundamental Study Nature of measure :- Qualitative Type of instrument :- Structured, disguised closed ended questionnaire Phase - I : Preliminary Phase Defining deha Prakriti and characters to be considered for its assessment, especially looking into its feasibility in children of different age groups ➢ Literature review ➢Consensus method with experts, academicians – via Delphi survey and nominal group technique. Phase – II: Tool Development and Validation Item generation and response scales: - Using same methods as in preliminary phase. Generating the domains pertaining to assessment of deha Prakriti in children of different age groups Framing questions and sub questions for the assessment of each domain. Selection of Type of response, response scales and formats: Response for each item will be decided through the same methods. Dichotomous response Continuous – Likert’s scale Pre-testing questionnaire: Face validity - Expert evaluation Content validity - Small sample study (10-30 respondents) Cognitive interview - Small sample study (5-10 experts) - Tested for comprehension, retrieval, judgement & response. Translation & back translation - Language experts - Tested for relevance, clarity, simplicity and ambiguity. Reliability assessment: Internal consistency (Homogeneity) - Cronbach’s α |