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CTRI Number  CTRI/2025/05/086440 [Registered on: 06/05/2025] Trial Registered Prospectively
Last Modified On: 05/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Screening
Other (Specify) [Breathing exercises and Asana ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study to evaluate the effect of breathing exercises and asana on lung functions in apparently healthy individuals 
Scientific Title of Study   A randomised comparative trial to evaluate the effect of Breathing exercises and Asana on the lung functions in apparently 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  Dr Saroj Godara 
Designation  MD Scholar 
Affiliation  National Institute Of Ayurveda 
Address  Room number 217 Advanced Human Physiology Lab PG Department of Kriya Sharir National Institute of Ayurveda Deemed to be University Jorawar Singh Gate Amer Road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  8302265904  
Fax    
Email  godarasaroj2696@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Chhaju Ram Yadav 
Designation  Dean Research & HOD  
Affiliation  National Institute Of Ayurveda 
Address  Department of Kriya Sharir National Institute of Ayurveda Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9460866101  
Fax    
Email  dr.yadavcr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bhanu Pratap Singh 
Designation  Assistant Professor 
Affiliation  National Institute Of Ayurveda 
Address  Department of Kriya Sharir National Institute of Ayurveda Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  8562816969  
Fax    
Email  bhanushekhawat17@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Deemed to be University Jaipur 302002 Rajasthan India 
 
Primary Sponsor  
Name  National Institute of Ayurveda Jaipur  
Address  Amer Road near Jorawar Singh Gate Jaipur 302002 Rajasthan India 
Type of Sponsor  Research institution and hospital 
 
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 Saroj Godara   National Institute of Ayurveda Jaipur  Room number 217 Advanced Human Physiology Lab PG Department of Kriya Sharir National Institute of Ayurveda Jaipur 302002 Rajasthan India
Jaipur
RAJASTHAN 
08302265904

godarasaroj2696@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee National Institute of Ayurveda Jaipur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy individuals 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Breathing Exercise (Procedure Reference: Procedure Reference: Yoga sudha - A monthly journal of SVYASA – May 2021, ISSN 0972-074X, VOL. XXXVII, No. 5, Page no. - 17., Procedure details: Group A comprising of 30 apparently healthy subjects & will perform Breathing exercises in morning. Types of Breathing Exercises • Hands in & out breathing • Ankle stretch breathing • Tiger breathing • Alternate straight leg raising breathing Duration of Breathing Exercises- The duration of Breathing exercises training will be of total 30 minutes which includes 10 minutes of warm up/Sookshma Vyayama & 20 minutes of stretching Breathing exercises. )
2Comparator ArmProcedure-Group B Asana (Procedure Reference: Asana Pranayama Mudra Bandha by Swani Satyanand Saraswati – publication – Bihar Yoga Bharati, Bihar India, Procedure details: Group B comprising of 30 apparently healthy subjects & will perform Asana in morning. Asana type- • Hastottanasana • Pada-hastasana • Shashankasana • Ustrasana Duration of Asana-The duration of Asana training will be of total 30 minutes which includes 10 minutes of warm up/Sookshma Vyayama & 20 minutes of Asana)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Apparently healthy individuals of either sex
Individuals fit for breathing exercises and Asana 
 
ExclusionCriteria 
Details  Already diagnosed with any acute or chronic systemic illness
Known case of any respiratory disorder such as asthma chronic obstructive pulmonary disease emphysema etc
Individuals contraindicated for selected breathing exercises and Asana
Pregnant and lactating women
Individuals practicing breathing exercises and Asana for more than one month 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Comparison of effects of Breathing Exercises and Asana on lung functions in apparently healthy individuals  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of effects of Breathing Exercises & Asana on Pranavaha Srotas in apparently healthy individuals  8 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 2 
Date of First Enrollment (India)   19/05/2025 
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)   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  

NEED OF STUDY    

Now a days, the increase in sedentary lifestyle and advance in modern technology have almost completely eliminated the necessity for physical exertion in daily life. Physical inactivity is a contributing factor in decreasing the lung function efficiency which in turn affects the functional status of respiratory system. Maintaining optimal lung function directly correlates with an individual’s quality of life. Monitoring and managing respiratory health contribute to overall well-being, allowing individuals to engage in daily activities with ease and vitality.  Spirometry is considered the gold standard for the measurement of lung function. It can, however, not provide information on certain lung volumes and capacities like residual volume (RV), functional residual capacity (FRC), and total lung capacity (TLC), while body plethysmography allows determining these and other characteristics, such as airway resistance and intra thoracic gas volume (ITGV)

RESEARCH GAP

Despite a growing interest in alternative and complementary therapies for respiratory health, a comprehensive exploration of the impact of Breathing exercises and Asana on lung functions including the residual volume through body plethysmography remains notably absent in existing literature. To fill this research gap this study is planned.

RESEARCH QUESTION

Is there any difference in the effect of Breathing exercises and Asana on the lung functions of apparently healthy individuals?

NULL HYPOTHESIS (H0)

There is no difference in the effects of Breathing exercises & Asana on the lung functions of apparently healthy individuals.

ALTERNATE HYPOTHESIS (H1)

There is difference in the effects of Breathing exercises & Asana on the lung functions of apparently healthy individuals.

AIM

To study and compare the effect of Breathing exercises & Asana on lung functions in apparently healthy individuals.

 OBJECTIVES

To explore the physiology of Pranavaha Srotas.

To assess the effect of Breathing exercises on lung functions of apparently healthy individuals.

To assess the effect of Asana on lung functions of apparently healthy individuals.

To compare the effect of Breathing exercises & Asana on lung functions of apparently healthy individuals.

 

GROUPING-

Individual who fulfill the inclusion criteria & are willing to sign written consent form will be selected & grouped into two groups A & B.

Group A comprising of 30 apparently healthy subjects & will perform Breathing exercises in morning.

Types of Breathing Exercises

  • Hands in and out breathing
  • Ankle stretch breathing
  • Tiger breathing
  • Alternate straight leg raising breathing

Duration of Breathing Exercises- The duration of Breathing exercises training will be of total 30 minutes which includes 10 minutes of warm up/Sookshma Vyayama and 20 minutes of stretching Breathing exercises.

Group B comprising of 30 apparently healthy subjects & will perform Asana in morning.

    Asana  type-

  • Hastottanasana
  • Pada-hastasana
  • Shashankasana
  • Ustrasana
  • Duration of Asana-The duration of Asana training will be of total 30 minutes which includes 10 minutes of warm up/Sookshma Vyayama and 20 minutes of Asana. Assessment of subjects for lung functions will be done by using Body Plethysmograph before & after Breathing exercises in one group & Asana in other group.
  • ASSESSMENT CRITERIA-

    • Total Lung Capacity (TLC)
    • Residual Volume (RV)
    • Vital Capacity (VC)
    • Forced Vital Capacity (FVC)
    • Pranavaha Srotas functions (Questionnaire)
    • PRIMARY OUTCOME
    •  Comparison of effects of Breathing Exercises and Asana on lung functions in apparently     healthy individuals.
    •    SECONDARY OUTCOME

       Comparison of effects of Breathing Exercises and Asana on Pranavaha Srotas in apparently     healthy individuals.

      STATISTICAL ANALYSIS -

      For intra group comparison paired ‘t’ test will be applied.

      For inter group comparison unpaired ‘t’ test will be applied.

       

      DECLARATION

       Enrollment of the subjects for clinical trial will be started only after approval of ethics committee and registration of clinical trial in CTRI (Clinical Trial Registry of India).

       

 
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