| CTRI Number |
CTRI/2025/03/081868 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
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Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study On Ventilatory Efficiency In Different Dvandvaja Deha Prakriti |
|
Scientific Title of Study
|
An Analytical Study To Find Association Between Deha Prakriti And Ventilatory Efficiency In Apparently Healthy Individuals In And Around National Institute Of Ayurveda Jaipur |
| 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 Khicchi Afrin Mustafa |
| Designation |
Md Scholar |
| Affiliation |
National Institute Of Ayurveda |
| Address |
Department Of Kriya Sharir National Institute Of Ayurveda Deemed University Jaipur Rajasthan 302002 India
Jaipur
RAJASTHAN
302002
India |
| Phone |
7709571314 |
| Fax |
|
| Email |
khicchiafrin786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahndra Prasad |
| Designation |
Associate Professor |
| Affiliation |
National Institute Of Ayurveda Jaipur |
| Address |
Department Of Kriya Sharir National Institute Of Ayurveda Deemed University Jaipur Rajasthan 302002 India
Jaipur
RAJASTHAN
302002
India |
| Phone |
9887315717 |
| Fax |
|
| Email |
mprasadmahendra5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Prakash Gurao |
| Designation |
Assistant Professor |
| Affiliation |
National Institute Of Ayurveda Jaipur |
| Address |
Department Of Kriya Sharir National Institute Of Ayurveda Deemed University Jaipur Rajasthan 302002 India
Jaipur
RAJASTHAN
302002
India |
| Phone |
9284142677 |
| Fax |
|
| Email |
drrashmigurao@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Ayurveda Deemed University Jorawar Singh Gate Jaipur Rajasthan 302002 |
|
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Primary Sponsor
|
| Name |
National Institute Of Ayurveda |
| Address |
Madhav Vilas Palace Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002 India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NOT APPLICABLE |
NOT APPLICABLE |
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Khicchi Afrin Mustafa |
National Institute Of Ayurveda Jaipur |
Department Of Kriya Sharir Advanced Human Physiology Lab Nia Du Jaipur Rajasthan 302002 India
Jaipur
RAJASTHAN |
7709571314
khicchiafrin786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently Healthy Individuals Will Be Selected As Per The Inclusion Criteria |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Individual of either sex between age group of 18-40 years
2.Apparently healthy individual having Dvandvaja Prakriti will be selected
3.Individual who are willing to sign the consent form.
|
|
| ExclusionCriteria |
| Details |
1.Known case of any acute or chronic Respiratory disorders.
2.Any individual with Tobacco addiction, Alcohol addiction or under the influence of any medications.
3.Any individual with history of cardiac pacemaker implantation or angioplasty.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome
1.Association between Dvandvaja Deha Prakriti and Ventilatory efficiency in apparently healthy individuals.
Secondary Outcome
2.Difference in Respiratory Quotient (RQ) in different Dvandvaja Deha Prakriti.
3.Difference in PET CO2 in different Dvandvaja Deha Prakriti.
|
78 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcome
1.Difference in Respiratory Quotient (RQ) in different Dvandvaja Deha Prakriti.
2.Difference in PET CO2 in different Dvandvaja Deha Prakriti.
|
78 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/05/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
N NEED OF STUDY : Studying the association between different Deha Prakriti and Ventilatory Efficiency will be useful for health understanding such as it helps in understanding how different Deha Prakriti may affect physiological parameters like oxygen consumption and ventilation providing insights into individual health characteristics also this type of correlation can lead to tailored customized health interventions based on an individual’s Deha Prakriti This type of correlation will helpful for potentially optimizing exercise regimens respiratory therapies, overall wellness strategies. Recognizing patterns between Deha Prakriti and Ventilatory efficiency can aid in preventive healthcare by predicting potential risks or vulnerabilities associated Overall investigating the relationship between Dehaprakriti and Ventilatory efficiency can enhance our understanding of individualized health characteristics and inform targeted interventions for better health outcomes.
RESEARCH GAP ANALYSIS: Previously no study had been conducted to find out the association between Deha Prakriti and Ventilatory efficiency Therefore to fill this gap analytical study to find out the association between Deha Prakriti and Ventilatory efficiency in a healthy individual will be conducted in and around the National Institute of Ayurveda Jaipur RESEARCH QUESTION : Is there any association between Deha Prakriti and Ventilatory Efficiency in apparently healthy individuals in and around the National Institute of Ayurveda Jaipur? STATEMENT OF HYPOTHESIS: Null hypothesis(H0) There is no association between Deha Prakriti and Ventilatory efficiency in apparently healthy individuals in and around the National Institute of Ayurveda Jaipur Alternate hypothesis(H1) There is an association between Deha Prakriti and Ventilatory efficiency in apparently healthy individuals National Institute of Ayurveda Jaipur AIM : To find the Association between Deha Prakriti and Ventilatory Efficiency in apparently healthy individuals in the National Institute of Ayurveda Jaipur. OBJECTIVES PRIMARY OBJECTIVES - To screen and assess the Dvandvaja Deha Prakriti in apparently healthy individuals
- To assess the Ventilatory efficiency in screened apparently healthy individuals
- To study the association between Dvandvaja Deha Prakriti and Ventilatory Efficiency
SECONDARY OBJECTIVES - To assess the Respiratory Quotient in screened apparently healthy individuals in and around the National Institute of Ayurveda Jaipur
- To assess the PET CO2 in screened apparently healthy individuals in and around the National Institute of Ayurveda Jaipur
INCLUSION CRITERIA - Individuals of either sex between age group of 18-40 years
- Apparently healthy individual having Dvandvaja Prakriti will be selected.
- Individuals who are willing to sign the consent form.
EXCLUSION CRITERIA - Known case of any acute or chronic Respiratory disorders.
- Any individual with Tobacco addiction, Alcohol addiction or under the influence of any medications.
- Any individual with history of cardiac pacemaker implantation or angioplasty.
ASSESSMENT CRITERIA Prakriti assessment by using validated proforma Assessment of Ventilatory Efficiency in different Dvandvaja Deha Prakriti will be done on Cardiopulmonary Exercise Testing the parameters obtained and used for interpretation include - Ventilatory equivalent for Carbon dioxide
- Respiratory Quotient /Respiratory Exchange ratio
- Minute ventilation
- Rate of Oxygen Consumption: Oxygen uptake
- End-tidal CO2-PETCO2
INVESTIGATION- Tread Mill Test (Cardio Pulmonary Exercise Test) GROUPING – Grouping will be done in 3 groups - Group A-40 individuals of Vata-Pitta Prakriti Pitta -Vata Prakriti
- Group B-40individuals of Pitta-Kapha Prakriti Kapha Pitta Prakriti
- Group C-40individuals of Kapha-Vata Prakrit Vata Kapha Prakriti
OUTCOME Primary Outcome - Association between Dvandvaja Deha Prakriti and Ventilatory efficiency in apparently healthy individuals.
Secondary Outcome - Difference in Respiratory Quotient (RQ) in different Dvandvaja Deha Prakriti.
- Difference in PET CO2 in different Dvandvaja Deha Prakriti.
STATISTICAL ANALYSIS Descriptive Statistics: Mean, Mode, Median, Standard Error, Standard deviation etc. Observations will be presented in graphs, charts, and tables.
Inferential Statistics: The data can be statistically inferred using the Chi-squared test and Pearson correlation coefficient.
ETHICAL CLEARANCE Ethical clearance will be obtained from the Institutional Ethical Committee of the National Institute of Ayurveda Jaipur
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