| 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
|
|
|
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
|
|
|
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. |