| CTRI Number |
CTRI/2025/03/082705 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Development and validation of Physical strength assessment tool in healthy participants. |
|
Scientific Title of Study
|
Development and Validation of Sharira Bala assessment tool in healthy individuals. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Komal B Kale |
| Designation |
MD scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Room no 624 6th floor Department of Kriya Sharira Institute of Teaching and Research in Ayurveda,Opposite B Division Police Station Gurudwara Road Jamnagar,
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
7038834895 |
| Fax |
|
| Email |
komalkale926@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati N Khandale |
| Designation |
Assistant Professor ITRA |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Room no 622, 6th floor Department of Kriya Sharira Institute of Teaching and Research in Ayurveda,Opposite B Division Police Station Gurudwara Road Jamnagar,
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9850483223 |
| Fax |
|
| Email |
drswatik@itra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Komal B Kale |
| Designation |
MD scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Room no 624 6th floor Department of Kriya Sharira Institute of Teaching and Research in Ayurveda,Opposite B Division Police Station Gurudwara Road Jamnagar,
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
7038834895 |
| Fax |
|
| Email |
komalkale926@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda opposite reliance smart near B division police station gurudwara road Jamnagar Gujarat 361008 |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Opposite Reliance Smart Near B Division Police Station Gurudwara Road Jamnagar, Gujarat, 361008 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Komal B Kale |
Institute of Teaching and Research in Ayurveda, Jamnagar |
OPD no C-16 Kriya Sharira Department Institute of Teaching and Research in Ayurveda hospital Jamnagar
GUJARAT
Jamnagar
GUJARAT |
7038834895
komalkale926@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute of Teaching and Research in Ayurveda Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently healthy participants |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Apparently healthy individuals
2.Participants irrespective of sex, caste, religion, occupation.
3.Participants willing and able to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.Diagnosed cases of Diabetes and other chronic systemic diseases such as cardiac disease,
Pulmonary tuberculosis etc.
2.Pregnant and Lactating women.
3. Vulnerable groups
4. Participants suffering with any psychological disorder. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The goal of the current research is to provide a standardised tool for assessing Sharira
Bala from an Ayurvedic and contemporary perspective. |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. The standardisation of clinical evaluation techniques associated to Sharira Bala is the
focus point of this particular piece of work. The desired result is a standardised consistent
tool for clinical examinations that will direct or provide lead to the physicians to arrive at
the assessment of a Sharira Bala from an Ayurvedic and contemporary perspective.
2. The established standard format for clinical examination will act as the foundation stone
for developing the full Ayurvedic clinical diagnosis technique. |
1 Year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2025 |
| Date of Study Completion (India) |
24/07/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
INTRODUCTION
“Bala” refers to an
individual’s physical and mental resilience, which can be evaluated in both healthy and
unhealthy individuals. “Sharira Bala” meaning strength, which underlies
related ideas like Ojas, Vyadhi Kshamatva, and more. Contemporary
sciences measure physical strength using tools like, Modified Harvard Step Test
and parameters such as Physical Fitness Index and Maximal Oxygen Consumption. It
serves as a vital energy source, essential for the body’s nourishment, growth
and defence mechanisms, ultimately supporting the sustenance of life. In
essence, "Bala" is the fundamental force that fuels the body’s
overall functioning and well-being.
RATIONALITY OF THE TOPIC
The concept of Bala, which measures an
individual’s strength and endurance, has received limited attention in
research, with different studies reporting it in different ways. In ayurveda some tools are available which
consider only single parameter such as Ojas or Vyadhikshamatva etc
as assessment factor, but no tool has been developed for comprehensive Bala assessment
according to Ayurveda and contemporary point of view. Different researchers tend to report Bala
in different ways such as Dhatusarata, Prakriti, Ojas, Vyadhikshamatva etc.
Currently, there isn’t a standardized tool to assess overall Bala.
To address this gap, this research is designed.
AIM
To develop and
validate a standardized tool for Sharira Bala assessment.
OBJECTIVES
To develop a
standardized Sharira Bala assessment tool with objectivity,
validity, and reliability.
AIM AND
OBJECTIVES FOR PILOT STUDY
To assess Sharira Bala in general population of
Jamnagar with the help of newly developed Sharira Bala assessment
tool.
MATERIALS
AND METHODS
100 desired
volunteer participants between age group 18 to 60 years will be taken in pilot study.
RESULTS
AND DISCUSSION
Data generated during the above study will be presented in a systemic
manner as shall be analyzed, where the important points of the review of
literature and data of pilot study based on statistical analysis will be
discussed.
|