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 |
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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 |
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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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Healthy individuals |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | 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. )
| 2 | Comparator Arm | Procedure | - | 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)
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|
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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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