| CTRI Number |
CTRI/2024/09/074487 [Registered on: 27/09/2024] Trial Registered Prospectively |
| Last Modified On: |
26/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Immediate effect of nadaanusandhana on EEG among Healthy individuals |
|
Scientific Title of Study
|
Immediate effect of nada anusandhana among healthy individual on brain wave in EEG (electroencephalogram) -a randomized control 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 Afsheen Rehman |
| Designation |
PG student |
| Affiliation |
Maharishi Aurabindo Subharti college and hospital of naturopathy and yogic sciences |
| Address |
Pg scholar room,Maharishi Aurabindo Subharti college and hospital of naturopathy and yogic sciences swami vivekanand Subharti university subhartipuram,NH-58,Delhi-haridwar Bypass Road,Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8171844990 |
| Fax |
|
| Email |
rehmanafsheen91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nair Dhiren Ajit |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Aurabindo Subharti college and hospital of naturopathy and yogic sciences |
| Address |
Department of pg studies,Maharishi Aurabindo Subharti college and hospital of naturopathy and yogic sciences swami vivekanand Subharti university subhartipuram,NH-58,Delhi-haridwar Bypass Road,Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7899143619 |
| Fax |
|
| Email |
danny.a.nair@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay MShankaregowda |
| Designation |
Principal |
| Affiliation |
Maharishi Aurabindo Subharti college and hospital of naturopathy and yogic sciences |
| Address |
Principal office,Maharishi Aurabindo Subharti college and hospital of naturopathy and yogic sciences swami vivekanand Subharti university subhartipuram,NH-58,Delhi-haridwar Bypass Road,Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9448300347 |
| Fax |
|
| Email |
naturopathy@subharti.org |
|
|
Source of Monetary or Material Support
|
| Dr. Afsheen Self-Financed, Swami Vivekanand Subharti University & Chhatrapati Shivaji Subharti
Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Afsheen Rehman |
| Address |
RCGH,Swami vivekanand Subharti university,subhartipuram,Meerut 250005 |
| 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 Afsheen Rehman |
Chhatrapati Shivaji Subharti Hospital,Meerut |
Department of Naturopathy OPD and IPD,Maharishi aurabindo subharti college and hospital of naturopathy and yogic science
Meerut
UTTAR PRADESH |
8171844990
rehmanafsheen91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UECM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nada anusandhana Meditation |
Nada anusandhana has been described by Yogi Goraksnatha; it means the search for transcendental sound. Transcendental means that which is beyond the categories of the mind, feeling, emotion, senses, and body. Nadanusandhan is a technique of Nadopsana that is supposed to attain the final truth in hath yoga. In the practice of Nadanusandhana meditation, various sounds such as A, U, M, and AUM are intentionally generated to elicit a profound resonance within the entirety of the physical form. It is only when the frequency of the produced sound aligns precisely with the inherent frequency of the individuals body that resonance can manifest. These resonances function as stimuli, stimulating the person to heighten their awareness and release even the most minuscule tensions. To achieve a refined resonance, one can experiment with adjusting the pitch while producing the different sounds of A, U, M, and AUM for 20 minutes. |
| Comparator Agent |
shavasana |
shavasanais an asana in hatha yoga and modern yoga as exercise,which is performed on the back with the legs spread as wide as the yoga mat and arms relaxed to both the sides of the body, and the eyes closed. The whole body is relaxed on the floor with an awareness of the chest and abdomen rising and falling with each breath. During Shavasana, all parts of the body are scaned for muscular tension of any kind.
Duration-20 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with good overall health
People who are willing to participate with writen concent |
|
| ExclusionCriteria |
| Details |
Neurological/psychiatric disorder
Under psychotropic Medication
Use of Drugs
Seizure Risks.
Inability to provide informed consent
History of trauma
Individuals contra-indicated for EEG |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
EEG(ELECTROENCEPHALOGRAM),
Alpha, Beta, Theta, Delta waves
|
Baseline and after 20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="163"
Sample Size from India="163"
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)
|
07/10/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A randomized controlled study, aim of this study is to investigate the immediate effects of Nada Anusandhana on the brain wave patterns of healthy individuals.This group is divided into two groups:The intervention group will be given nada anusandhana for 20 minutes and control group will be given shavasana for same time duration.Baseline assessment will be done before intervention and post data will be collected after the intervention.Nadanusandhana meditation, various sounds such as A, U, M, and AUM are intentionally generated to elicit a profound resonance. These resonances function as stimuli, stimulating the person to heighten their awareness and release even the most minuscule tensions.
This study will be a core strength for improving brain wave activity through nada anusandhana meditation without any side-effect.
|