| CTRI Number |
CTRI/2020/07/026554 [Registered on: 14/07/2020] Trial Registered Prospectively |
| Last Modified On: |
13/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Physical fitness & Its relation with Body Constitution Tissue excellence & Ayurvedic Anthropocentric Measurements |
|
Scientific Title of Study
|
Association of physical fitness with Sharir prakriti Dhatusarata & Charakokta Angulipraman |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sharayu Pramod Phule |
| Designation |
PhD (Scholar) |
| Affiliation |
Bharati Vidyapeeth Deemed to be University College of Ayurved and hospital Pune 43 |
| Address |
Bharati Vidyapeeth Deemed to be University
College of Ayurved and hospital Pune 43
Bharati Vidyapeeth Deemed to be University
College of Ayurved and hospital Pune 43
Pune
MAHARASHTRA
411043
India |
| Phone |
9145177211 |
| Fax |
020-24373954 |
| Email |
drsharayuphule@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umesh S Ghate |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be University College of Ayurved and hospital Pune 43 |
| Address |
Bharati Vidyapeeth Deemed to be University
College of Ayurved and hospital Pune 43
Bharati Vidyapeeth Deemed to be University
College of Ayurved and hospital Pune 43
Pune
MAHARASHTRA
411043
India |
| Phone |
7276862884 |
| Fax |
020-24373954 |
| Email |
drumeshghate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharayu Pramod Phule |
| Designation |
PhD (Scholar) |
| Affiliation |
Bharati Vidyapeeth Deemed to be University College of Ayurved and hospital Pune 43 |
| Address |
Bharati Vidyapeeth Deemed to be University
College of Ayurved and hospital Pune 43
Bharati Vidyapeeth Deemed to be University
College of Ayurved and hospital Pune 43
Pune
MAHARASHTRA
411043
India |
| Phone |
9145177211 |
| Fax |
020-24373954 |
| Email |
drsharayuphule@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed to be University, College of Ayurved and hospital, Pune |
|
|
Primary Sponsor
|
| Name |
Dr Sharayu Pramod Phule |
| Address |
A-106,Saidham Ardra Society, Behind Chiplun Tahsil Office, Pagzari, Chiplun, Tal.Chiplun, Dist.Ratnagiri |
| Type of Sponsor |
Other [academician] |
|
|
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 Sharayu Pramod Phule |
Bharati Vidyapeeth Deemed to be University, College of Ayurved |
Department of Kriyasharir, Third Floor, Bharati Vidyapeeth Deemed to be University, College of Ayurved and hospital, Pune.43.
Pune
MAHARASHTRA |
9145177211
020-24373954
drsharayuphule@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee [BV(DU)COA-EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
1. Healthy male and female subjects.
2. Age group - 22-35 years
|
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy male and female subjects.
2. Age group - 22-35 years.
|
|
| ExclusionCriteria |
| Details |
1. Subject suffering from any major physical, cardiovascular, musculoskeletal, and psychological or any other systemic illness.
2. Pregnant and lactating women.
3. Subjects which are physically handicapped.
|
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Study may possibly validate the hypothesis that Kapha Dosh Pradhan prakriti , Uttam Dhatusara (Mamsasara Asthisara, Majjasara, Shukrasara) & Pramanvat Sharir individuals are endowed with higher physical fitness. |
12 weeks
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
The selected individuals will be benefited by knowing their Sharir prakriti, Dhatusarata as well as measurements of all pratyangas in terms of angulipraman and anthropometry.
Individuals will be also benefited by knowing there levels of physical activity and physical fitness consequently will be helpful in planning and designing more effective strategies for preservation of health.
The study will promote positive behaviour related to an increase in fitness & good health habits
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
15/07/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ayurveda has a holistic approach and includes all the factors
which are absolute or accessory in the determination of health. Prakriti is one of the most important
concepts and it is decided at the time of conception according to
the predominance of dosha. Each prakriti has specific physical
and mental characteristics which totally depend on the involvement of dosha.
For instance, individual with vatal constitution is physically weak; individual with pittal constitution
is endowed with moderate strength; while person of shleshmal constitution
is endowed with the excellence of physical strength & fitness. Thus assessment of prakriti
is helpful to decide comparative differences in strength & fitness of
individual. Qualitative, quantitative and functional assessment of
all dhatus is called as dhatu sarata or tissue excellence. Sara parikshana gives clear vision about the
individual’s exclusive physical as well as mental
strength & abilities. It is possible to enhance the sarata
or excellence of dhatus in individual having poor qualities
of dhatus by following proper diet regimen and medication. Thus dhatusarata parikshana helps in rebuilding
the body strength & fitness. Praman sharir is one of the concepts in the sharir of ayurveda
text which deals with the measurement of various body parts
and fluids in a normal healthy individual. It has been stated by Acharya
Charak that individuals with pramanvat sharir are endowed with higher strength. In the
light of modern or current science, strength & fitness means the organic
system of the body is healthy and functions efficiently with vigorous tasks and
leisure activities. Assessment of physical fitness is a
significant indicator of the health and also a good predictor of health in
later life. Previous studies have
used Harvard step test for quantitative estimation of physical strength which is not comprehensive. In present era, proper
and scientific assessment of physical fitness is possible by employing comprehensive modern ‘Battery of Tests of
physical fitness’. Physical Fitness, health
and wellness are playing a vital role in the life of human. A fit and healthy person will live longer, be more productive at work and
generally contribute more to the country’s growth and development. Considering above mentioned facts, this
research is an attempt
to assess physical fitness with evidence based scientific
tool and to validate its association with sharir prakriti, dhatusarata, Charakokta
angulipraman. Plan of work 1. OBSERVATIONAL STUDY. 20 2oo Healthy Subjects, Both Male and female, Age between 22-35 years, Selected randomly. 2. Counseling
& Informed written consent 3. Assessment of Sharir Prakriti & Dhatusarata of each
subject will be done with the help of AYUSOFT C-DAC format 4. Assessment of Charakokta Angulipraman of each subject will be done according
to criteria of assessment 5. Assessment of Physical fitness of each subject will be done with the help of Testers’ Manual of the ALPHA-FIT
Test Battery for Adults. 6. Observation, compilation, comparison
of data & Statistical analysis 7. Evaluation & discussion
will be done on the basis of literature study, observations and statistical
analysis of collected data to study association of physical fitness with Sharir
Prakriti, Dhatusarata & Charakokta Angulipraman
|