| CTRI Number |
CTRI/2023/05/052224 [Registered on: 02/05/2023] Trial Registered Prospectively |
| Last Modified On: |
29/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
To study the concept of prana and the effect of Pranakarshan Pranayam on mental state and quality of life |
|
Scientific Title of Study
|
Effect of Pranakarshan Pranayam on Brain Waves - With Special Reference to Ancient and Modern Concepts of Prana |
| Trial Acronym |
no |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shilpi Verma |
| Designation |
Research Scholor |
| Affiliation |
Dev Sanskriti Vishwavidyalaya Haridwar,Uttrakhand |
| Address |
Department of Yogic Science & Human Consciousness, Shriram Bhavan, Room No. 206, Dev Sanskriti Vishwavidyalaya,Gayatrikunj Shantikunj Haridwar,Uttrakhand.
Hardwar UTTARANCHAL 249411 India |
| Phone |
9557226530 |
| Fax |
|
| Email |
shilpi.verma@dsvv.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Manorama Nikhra |
| Designation |
Assistant Professor |
| Affiliation |
Department of Yogic Science and Human Consciousness, Dev Sanskriti Vishwavidyalaya |
| Address |
Department of Yogic Science and Human Consciousness, Dev Sanskriti Vishwavidyalaya Gaytrikunj-Shantikunj, Haridwar, Uttarakhand
Hardwar UTTARANCHAL 249411 India |
| Phone |
8279985628 |
| Fax |
|
| Email |
manorama.nikhra@dsvv.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Shilpi Verma |
| Designation |
Research Scholor |
| Affiliation |
Dev Sanskriti Vishwavidyalaya Haridwar,Uttrakhand |
| Address |
Department of Yogic Science & Human Consciousness, Shriram Bhavan, Room No. 206, Dev Sanskriti Vishwavidyalaya,Gayatrikunj Shantikunj Haridwar,Uttrakhand.
Hardwar UTTARANCHAL 249411 India |
| Phone |
9557226530 |
| Fax |
|
| Email |
shilpi.verma@dsvv.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Yogic Science & Human Consciousness, Shriram Bhavan, Room No. 206, Dev Sanskriti Vishwavidyalaya,Gayatrikunj Shantikunj Haridwar,Uttrakhand. |
|
|
Primary Sponsor
|
| Name |
shilpi verma |
| Address |
agastya bhavan ,Dev Sanskriti Vishwavidayalaya ,Gayatrikunj Shnatikunj ,Haridwar,Uttrakhand249411 |
| Type of Sponsor |
Other [SELF SPONSORED] |
|
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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 |
| Shilpi Verma |
Dev Sanskriti Vishwavidyalaya |
Room Number 206, Shriram Bhavan, Department of Yogic Science and Human Consciousness, Dev Sanskriti Vishwavidyalaya, Gyatrikunj, Shantikunj, Haridwar, Uttarakhand, 249411 Hardwar UTTARANCHAL |
9557226530
shilpi.verma@dsvv.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| REC-DSVV |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pranakarshan Pranayam |
Frequency of intervention- daily for 60 days
Duration of intervention-20 minutes per day
Pranakarshan Pranayama, given by Pandit Shriram Sharma Acharya (Acharyashri), is a Pranayama in which yogic breathing is done along with deep emotional engrossment and determination, and efforts are made to imbibe, the conscious life force prevailing in the universe, within the body through breathing. [Sharma, S.(1995)]. The success of Pranakarshan Pranayama completely depends on the firmness of will power [Sharma, S.R. (1995)]; it is well known that actions produce the desired result only when full emotional engrossment and determination are attached to them.
|
| Comparator Agent |
Soham Sadhana |
Frequency of intervention- daily for 60 days
Duration of intervention-20 minutes per day
Soham is considered to be a breathing mantra because “So†is the sound of inhalation and “Ham†– that of exhalation. Apart from a breathing mantra, Soham is also a mantra aiming at the definite mind concentration. It is usually used in pranayama techniques but actually every person repeats it unconsciously with every breath taken. If you learn to listen to your own breathing and to focus on yourself, it shall be much easier for you to find your way to your Kama, Dharma and Artha .[ Sharma S(1947) |
|
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Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Age – 22 to 30 years
Willing and capable of participating in the intervention
Willing to fill the consent form
Having no chronic or acute physical or mental disease Having no background of Pranayama and Meditation in routine life |
|
| ExclusionCriteria |
| Details |
Unwilling or incapable of following the procedure
Having breathing problem or any other respiratory disorder
Having chronic or acute physical or mental disease
Pranayama & Yogic practices performer in routine life
Regular/Advanced spiritual practitioner
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The effect of Pranakarshan Pranayam on the brain function / mental activity |
Baseline, 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The effect of Pranakarshan Pranayam on the quality of life |
Baseline, 60 days |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2023 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Within the Indian Knowledge System, Yoga is an important approach that identifies lack of vitality/immunity as the root cause of almost all the ailments, and provides various methodologies for enhancing the same. In this regard, the role of Pranayama in enhancing vitality/immunity, which in turn provides sound health, has been well documented in the Yogic scriptures, and demonstrated by modern research1. Prana is the gross and subtle power that pervades the universe, and it is active in all living beings. The essential quality of Prana is life; where there is Prana, there is life. Physical, intellectual, mental, spiritual - all kinds of activities take place in the presence of Prana7 . There are various methods available in ancient Indian scriptures with regards to modulating Prana for attaining favorable outcomes - these include different streams of Indian Knowledge System such as Yoga, etc. Yoga is the supreme state of consciousness where the senses, the mind, and the life force (Prana) are all in harmony8 . In the yogic literature, the significance of Prana-tatva is described in detail. Yoga includes various methodologies for enhancing the Prana, such as asanas, pranayama, meditation, etc9,10. In this regard, the role of various kinds of Pranayama in enhancing the Prana-tatva, which in turn leads to the attainment of sound health, has been well documented in the Yogic scriptures and demonstrated by modern research11. Pranayama is generally thought to be the regulation of the breathing process. However, Pranayama is a compound term made up of the words Prana and Ayama3, which indicates the extension and growth of Prana on the subtle plane. The tangible benefits of Pranayama are bodily strength, thinking power, and firm mental resolve; within this, not only are the lungs exercised, but Pranayama augments one’s life span and potency.12 Pranakarshan Pranayama given by Pandit Shriram Sharma Acharya,2,13 is one such technique, wherein the practitioner is supposed to imagine, with full mental concentration and emotional engrossment, that the Prana spread in the cosmos is being absorbed by his entire being during inhalation. With exhalation, all the vices are being expelled. This cleansing and enrichment process is supposed to enhance the overall vitality, which in turn can ascertain sound health2. Among the available modern methods for assessing the effects of Prana modulation on the brain function, as well as its manifestation on the physical body, recording the variation in Brain Waves through electroencephalogram (EEG) is an important one14,1,5. Some research studies have shown that meditation techniques result in an increase in the parieto-occipital 60–110 Hz gamma amplitude1,5. Another study showed that a package of Yoga Nidra and Pranakarshan Pranayama had a significant impact on the alpha EEG pattern1.
Therefore, the present proposal seeks to analyze the concept of Prana as given in the Indian Knowledge System, and understand its importance in Pranayam. It will evaluate the effect of Pranakarshan Pranayama on mental activity measured through brainwaves, and on comprehensive health measured through WHO-BREF scale for assessing Quality of life, thus providing a sound scientific basis for its observed outcomes, as well as its utility for the society. |