| CTRI Number |
CTRI/2023/11/060104 [Registered on: 21/11/2023] Trial Registered Prospectively |
| Last Modified On: |
06/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Pranic energisation technique on Heart rate and Lung function on healthy individuals. |
|
Scientific Title of Study
|
“IMMEDIATE EFFECT OF YOGA PRANIC ENERGISATION TECHNIQUE (YPET) ON HEART RATE VARIABILITY AND PULMONARY FUNCTION ON HEALTHY INDIVIDUALS – A RANDOMIZED CONTROL TRAIL†|
| 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 Shreedevi |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences |
| Address |
Department of Yoga Therapeutics, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire Belthangadi
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9483487255 |
| Fax |
|
| Email |
shreebadigera136@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shreedevi |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences |
| Address |
Department of Yoga Therapeutics, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire Belthangadi
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9483487255 |
| Fax |
|
| Email |
shreebadigera136@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bindu Shridhar |
| Designation |
Associate professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences |
| Address |
Department of Yoga Therapeutics, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire Belthangadi
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8277614169 |
| Fax |
|
| Email |
bindu.shridhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara Yoga and Naturecure hospital Shantivana, Ujire, Belthangadi Taluk, Dakshina kannada District |
|
|
Primary Sponsor
|
| Name |
Dr Shreedevi |
| Address |
Department of Yoga therapeutics, Sri Dharmasthala
manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire, Belthangadi, Dakshina kannada 574240
|
| 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 Shreedevi |
Sri Dharmasthala Manjunatheshwara Yoga and Naturecure hospital Shanthivana |
1st floor, Department of
Yoga Therapeutics,
Shanthivana,
Dharmasthala Dakshina
Kannada, Karnataka
574216
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA |
9483487255
shreebadigera136@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM College of Naturopathy and Yogic sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preventative |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pranic energization Technique |
1. Step 1 - Prayer: Become a child and pray to all-pervading mother prana
Pranasyedam vase sarvam,
Tridive yat pratisthitam
Mateva putran raksasva
Srisca prajnanca vidhehi na iti
2. Step 2 - Relaxation to perceive the prana
a. Phase I: Relax the lower limbs part by part up to the navel. Inhale deeply and
chant AAAA. Repeat 5 times. Feel the vibrations and guide them to the affected
area.
b. Phase II: Now relax the torso from navel up to the neck. Inhale deeply and chant
UUU. Repeat 5 times. Feel the vibrations and guide them to the affected part.
c. Phase III: Now relax the head and all sense organs in the face. Inhale deeply and
chant MMM. Repeat 5 times. Feel the vibrations and guide them to the affected
part.
3. Step 3 - Breath awareness & balancing by Nadisuddhi pranayama, Kapalabati
4. Step 4 - Awareness of nerve impulses, Vyana & Circulatory System & their movement,
by Mudras: Cin, Cinmaya, Adi & Namaskara mudras.
5. Step 5 - Scanning rotating and moving prana to recognize & correct the imbalances.
6. Step 6 - Expansion of prana to cosmic forces & energizing the immune defence system
by the power of mind.
7. Step 7 - Resolve
8. Step 8 - Balancing the prana by movement of hand on eyes, temples, eardrum, earpit,
throat pit, chest, navel & Namaskara mudra.
9. Step 9 - Share bliss with all.
Sarve bhavantu sukhinah
Sarve santu niramayah
Sarve bhadrani pasyantu
Ma kascit duhkha bhaghbgavet
|
| Comparator Agent |
Supine rest |
Simply lying down with closed eyes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Age: 18 to 25 years
Gender: male and female
Subjects who are given consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Students who is consuming nicotine and alcohol
Weak and debilitating individuals.
Systemic illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Autonomic function using heart rate variability |
Base line and immediately within 5 minutes of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pulmonary function using spirometry |
Base line and immediately within 5 minutes of intervention |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
Modification(s)
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/02/2024 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
TO EVALUATE THE IMMEDIATE EFFECT OF YOGA PRANIC ENERGISATION TECHNIQUE (YPET) ON HEART RATE VARIABILITY AND PULMONARY FUNCTION ON HEALTHY INDIVIDUALS
GROUING: Subjects will be allocated into two groups by computer generated randomization. Group 1: Pranic Energisation Technique (n ≥ 35) Group 2: Supine rest (n ≥ 35)
Method: The study subjects will be identified and screened as per the demands of the inclusion & exclusion criteria. Signed informed consent form will be obtained from every participant after an appraisal about the purpose of the study. Selected subjects will be randomly allocated into two groups by computer generated randomization method. Flow of participants will be as illustrated in the Fig 1.
Group 1: Subjects will receive Yoga pranic energisation technique for 25– 30 minutes. Group 2: Subjects will receive Supine rest for 25-30 minutes
Pre-assessment prior to the intervention and Post assessments will be done immediately within 5 min after the intervention using the variables. The data collected will be tabulated and analyzed using appropriate statistical methods. |