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CTRI Number  CTRI/2024/06/068566 [Registered on: 07/06/2024] Trial Registered Prospectively
Last Modified On: 20/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Nadishodhana Pranayama in Lung Volume and Oxygen Saturation 
Scientific Title of Study   Exploring the effect Of Nadishodhana Pranayama with Antar and Bahir Kumbhaka in Lung Volume & Oxygen Saturation among Healthy Individuals - A Randomized Controlled Trial. 
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 A Mohana Priya 
Designation  Post-Graduate scholar 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences 
Address  184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block(Ground Floor), Department of Yoga, Kamarajar Nagar, Chengalpattu.

Kancheepuram
TAMIL NADU
603001
India 
Phone  8939538685  
Fax    
Email  mohanamahi231994@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr A Gayathri 
Designation  Head Of Department (Yoga) 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences 
Address  184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block (Ground Floor), Department of Yoga, Kamarajar Nagar, Chengalpattu.

Kancheepuram
TAMIL NADU
603001
India 
Phone  8124634017  
Fax    
Email  gayathriannamalai93@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr A Mohana Priya 
Designation  Post-Graduate scholar 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences 
Address  184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block (Ground Floor), Department of Yoga, Kamarajar Nagar, Chengalpattu.

Kancheepuram
TAMIL NADU
603001
India 
Phone  8939538685  
Fax    
Email  mohanamahi231994@gmail.com  
 
Source of Monetary or Material Support  
International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block (Ground Floor), Department of Yoga, Kamarajar Nagar, Chengalpattu, Kancheepuram, Tamilnadu-603001, India 
 
Primary Sponsor  
Name  Dr A Mohana Priya 
Address  No.184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block (Ground Floor), Department of Yoga, Kamarajar Nagar, Chengalpattu  
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 A Mohana Priya  International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu  184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block(Ground Floor), Department of Yoga, Kamarajar Nagar, Chengalpattu.
Kancheepuram
TAMIL NADU 
8939538685

mohanamahi231994@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NIL 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nadishodhana Pranayama with Antar and Bahir Kumbhaka   The subjects will receive one day orientation program about the study before the trial. The instructions about the pranayama will be delivered via an audio with pre-recorded voice. This was done to maintain uniformity in terms of instruction and voice quality. The practice of practicing Nadishodhana pranayama (technique 4) involves 4 stages (i)Puraka (Inhalation) (ii)Antar Kumbhaka (Retention full) (iii) Rechaka (Exhalation) (iv)Bahir Kumbhaka (Retention empty) The Study participants will be ask to sit in any comfortable posture preferably Sukhasana with the head and spine upright. Relax the whole body and close the eyes. Practice yogic breathing for some time. By adopting Nasikagra mudra close the right nostril with the thumb. Inhale through the left nostril for 6s. Retain the breath in Antar Kumbhaka for 6s. Exhale through the right nostril for 6s. After exhalation, close both nostrils and hold the breath outside for 6s. The glottis may be slightly contracted to hold the air outside. Exhale slightly through the right nostril immediately before inhaling. Inhale slowly through the right nostril for 6s. Retain the breath for 6s. Exhale through the left nostril for 6s. Again, hold the breath outside for 6s with both nostrils closed. If necessary, exhale slightly through the right nostril before breathing in at the start of the next round constitute one round. Subjects will receive a intervention in a ratio of 1:1:1:1 for 6 s each for 10 minutes per day 5 days a week for a period of 4 weeks.  
Comparator Agent  Normal breathing with breath awareness  The subjects will receive one day orientation program about the study before the trial. The Participants will be asked to sit in Sukhasana and Relax the whole body by closing the eyes. Begin to practice equal inhalation and exhalation, using the ratio 1:1 with breath awareness for 10 mins per day 5 days a week for a period of 4 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  21.00 Year(s)
Gender  Both 
Details  1.BMI should be 18.5-24.9 kg/m2.
2.Individuals who have experience in practicing yoga including pranayama for a minimum of 6 months.
3.Patients who are willing to participate & give their consent.
Individuals should meet the oxygen saturation of 92-96% 
 
ExclusionCriteria 
Details  1.Participants who have systematic diseases, nasal passage pathology, and spinal deformities were
excluded from the study.
2.Those who are under medication for any illnesses.
3.Those who are not willing to give consent also will be excluded from the study. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Forced vital capacity(FVC), Forced expiratory volume in one second(FEV1), Forced expiratory flow(FEF) using digital spirometer monitor and oxygen saturation using Handheld Pulse oximeter  Assessment of Forced vital capacity(FVC), Forced expiratory volume in one second(FEV1), Forced expiratory flow(FEF) and oxygen saturation before and after the intervention for a period of 4 weeks in Healthy volunteers 
 
Secondary Outcome  
Outcome  TimePoints 
Systolic blood pressure, Diastolic blood pressure using Digital blood pressure monitor & Breath retention time will be recorded manually by using stopwatch  Assessment of Systolic blood pressure, Diastolic blood pressure & Breath retention time before & after the intervention for the period of 4 weeks in Healthy volunteers 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/07/2024 
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="1"
Days="1" 
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  

Much of the scientific literature supports the concept that daily lifestyle habits and actions impact long-term and short-term health & quality of life. Exposure to occupational hazards also contributes to the development and promotion of COPD occurrence in India. Respiratory problems are common in athletes with an incidence rate of 4.7 per athlete per year, where breathing can have the effect of limiting performance from a physiological point of view, or on the other hand, breathing can also regulate the psychological status. The process involves a sequence of activation and deactivation of respiratory skeletal muscles and bronchial smooth muscles may lead to oxygen desaturation. A recent study indicates that aerobic exercise raises pulmonary venous pressure at high exercise loads causing interstitial fluid accumulation and reduced oxygen transport. Elevated pulmonary venous pressure is directly related to left ventricular(LV) end-diastolic pressure which increases at a a high level of exercise as ventricles fail to relax diastole causing pulmonary congestion. They should enhance their ability to withstand very high cardiac outputs during maximal exercise while having low pulmonary venous pressure. Yoga is a systematic conscious process for accelerating the growth of a human being from animal level to divinity. Our body is made up of five sheaths of existence namely Anamaya kosha, Pranamaya kosha, Manomay kosha, Vijnanamaya kosha, and Anandhamaya kosha respectively. Disturbances in the Pranamaya kosha percolate the Manomaya kosha which leads to the development of Anadhija vyadhis. Regular yoga practices improve the aerobic capacity in both males and females by regulating the autonomic nervous system. It improves lung function and better utilization of oxygen at the cellular level by increasing the VO2 max. Pranayama is a science that helps to regulate vital energies in terms of regulation of breath by gaining control over ANS. Controlled breathing can help in turn in controlling both sympathetic and parasympathetic activity. The practice of Nadishodhana pranayama enhances the voluntary regulation of rhythmic breathing and maintains homeostasis of the body. During the practice, the subject will concentrate on breathing, improving pulmonary function. The oxygen demand will be improved When practiced in a relaxed state. The practice involves slow deep inspiration(Puraka), internal breath retention(Antar Kumbhaka), near complete expiration(Rechaka), and external breath retention(Bahir Kumbhaka) Normal subjects find it easier to hold their breath at lung volume near total lung capacity (TLC), partly due to increased oxygen stored in the lungs at high lung volume which leads to substantial prolongation of breath holding time attributing to neural input from pulmonary stretch receptors. There will be an increase in end-expiratory pressure during breath holding, as expiratory muscles increase their activity while ventilatory drive improves in CO2 breathing. Various studies have reported the effect of various pranayamas on cardiovascular changes, pulmonary function, and cerebrovascular hemodynamics but only a few studies have reported on the effect of Kumbhaka. Kumbhaka is an important phase of Nadishodhana pranayama where the retention of air is done under the voluntary control of the cerebral cortex over breathing centers in the brain stem which inhibits the stretch reflex mechanism. And to the best of our knowledge there is no study reporting the lung functions of Nadishodhana pranayama with Antar and Bahir Kumbhaka practice in healthy individuals or any pathological disorders. Hence, this study aimed to explore the effect of Nadishodhana pranayama with Antar and Bahir Kumbhaka on lung volume & oxygen saturation among healthy individuals.

 
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