| CTRI Number |
CTRI/2024/12/077727 [Registered on: 05/12/2024] Trial Registered Prospectively |
| Last Modified On: |
05/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Immediate Effect of AUM chanting on Pulmonary Function Test |
|
Scientific Title of Study
|
Immediate effect of AUM chanting on Pulmonary Function test among healthy individual-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 Rashme |
| Designation |
Under graduate student |
| Affiliation |
Department of Under Graduate Studies |
| Address |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences,Subharti University, Meerut
Subharti College and Hospital of Naturopathy and Yogic Sciences Swami Vivekanand Subharti University, Subhartipuram, Meerut, Uttar Pradesh
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7085339052 |
| Fax |
|
| Email |
rashmedungdung99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nair Dhiren Ajit |
| Designation |
Assistant Professor and Post Graduate(PG) Coordinator |
| Affiliation |
Department of Post Graduate Studies |
| Address |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences, Swami Vivekanand Subharti University
Subharti College and Hospital of Naturopathy and Yogic Sciences Swami Vivekanand Subharti University Subhartipuram Meerut Uttar Pradesh
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7899143619 |
| Fax |
|
| Email |
danny.a.nair@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay M Shankaregowda |
| Designation |
Principal and Dean |
| Affiliation |
Department of Post Graduate Studies |
| Address |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences, Swami Vivekanand Subharti University
Subharti College and Hospital of Naturopathy and Yogic Sciences Swami Vivekanand Subharti University Subhartipuram Meerut Uttar Pradesh
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9639010531 |
| Fax |
|
| Email |
naturopathy@subharti.org |
|
|
Source of Monetary or Material Support
|
| Naturopathy and Yoga IPD of Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences Swami Vivekanand Subharti Uiversity, Meerut, 250005, India |
|
|
Primary Sponsor
|
| Name |
Dr Rashme |
| Address |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences, Swami Vivekanand Subharti University, Meerut, 250005, India |
| Type of Sponsor |
Other [Intern] |
|
|
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 Rashme |
Maharishi Aurobindo Subharti University of Naturopathy and Yogic Sciences |
Swami Vivekanand Subharti University Subhartipuram Meerut Uttar Pradesh, 402
Meerut
UTTAR PRADESH |
7085339052
rashmedungdung99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee(Medical) Swami Vivekanand Subharti University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nil |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AUM chanting |
The intervention is given for 10 minutes. Subjects are asked to lie down in supine position and chant AAA kara for 2 minutes.Then again the subjects are asked to chant UUU kara for 2 minutes. Furthermore,the subjects are asked to chant MMM kara for 2 minutes. Lastly, the subjects are asked to chant AUM kara for 4 minutes. After completion of AUM kara chanting the immediate effect will be recorded.
|
| Comparator Agent |
Simple meditation for 10 minutes |
Subjects are asked to lie down in supine position and close their eyes and simply focus on their breath for 10 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Normal individual both without any disease conditions were included.
Subjects who are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
People with respiratory disorders - asthma, chronic bronchitis.
Recently underwent surgery or hospitalizations.
People with fever. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulmonary Function Test |
Immediately before and after intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart rate respiratory rate pulse rate |
Immediately before & after intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/12/2024 |
| Date of Study Completion (India) |
31/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Immediate effect of AUM chanting on Pulmonary Function Test among healthy individual -A Randomized controlled trial. Subjects are asked to chant A,U,M kara chanting for 2 minutes respectively and AUM kara chanting for 4 minutes. Pre and post intervention data will be recorded. |