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CTRI Number  CTRI/2025/03/083540 [Registered on: 26/03/2025] Trial Registered Prospectively
Last Modified On: 25/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study to observe how breathing (Prana Vayu, a concept from Ayurveda) functions in people with different body types (Deha Prakruti) and how it affects their ability to breathe. 
Scientific Title of Study   An observational study on function of prana vayu in Respiration in different deha prakriti w.s.r. to spirometry 
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 Swapnali Sukesh Lande 
Designation  MD Scholar Department of Kriya Sharir 
Affiliation  Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana 136118 
Address  Opd No 55A Department of Kriya Sharir Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra

Kurukshetra
HARYANA
136118
India 
Phone  9657730481  
Fax    
Email  swapnali052@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Vd P C Mangal 
Designation  Professor and Chairperson 
Affiliation  Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana 136118 
Address  Room No 12 Department of Kriya Sharir Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra

Kurukshetra
HARYANA
136118
India 
Phone  9416159505  
Fax    
Email  pmangla69@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Swapnali Sukesh Lande 
Designation  MD Scholar Department of Kriya Sharir 
Affiliation  Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana 136118 
Address  Opd No 55A Department of Kriya Sharir Institute for Ayurved Studiesand Research Umri Road Sector 8 Kurukshetra

Kurukshetra
HARYANA
136118
India 
Phone  9657730481  
Fax    
Email  swapnali052@gmail.com  
 
Source of Monetary or Material Support  
Institute for Ayurved Studies and Research Umri road sector 8 Kurukshetra Haryana 136118 
 
Primary Sponsor  
Name  Dr Swapnali Sukesh Lande 
Address  OpdNo 55A Department Of Kriya Sharir Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana 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 Swapnali Sukesh Lande   Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra   Opd no 55A Department of Kriya Sharir Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra
Kurukshetra
HARYANA 		 9657730481

swapnali052@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Shri Krishna Ayush University Kurukshetra Haryana  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pulmonary function  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Patient willing to participate in the trial. Patient with age between 20-30years. Patient of both male and female sex. 
 
ExclusionCriteria 
Details  1 Known case of asthma, emphysema, weakness or paralysis of respiratory muscle.
2 Known case of pulmonary edema, pulmonary tuberculosis.
3 Known case of allergic Rhinitis, Sinusitis.
4 Known case of covid
5 Pregnant women & lactating mother
6 History of alcohol intake & smoking.
7 History of Cardiac illness.
8 History/ known case of malignancy
9 Athletes.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Correlation between Prakriti and Lung Capacity: Establishing significant correlation between prakriti types and lung capacity pattern (i.e. diff FVC, FEV1 etc.)  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
1 Customized Intervention: Development of Personalized health interventions like dietary recommendations & Lifestyle modification based on prakriti type.
2 Improved patient Outcome:Creation of different prakriti based specific guidelines for managing different respiratory disorders.
3 Scientific Validation:Empirical validation of ayurvedic principles, enhancing their credibility & integration into conventional medicine.
4 Educational tool:Development of educational materials & training program for healthcare provider & provide further research directions. 		 60 days 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   15/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/04/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="2"
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   Total 90 patients will be enrolled for the study purpose having age group between 18-30 years irrespective of sex, caste, race, religion and socia economic status.Written consent will be taken from the volunteer patients in their easy understandable language. There will be three groups :-Group A(Vata dominant),Group B(Pitta Dominant), Group C( Kapha dominant). The observation and results will be analysed and presented in accordance with the respective and applicable statistical tests. 
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