| CTRI Number |
CTRI/2025/03/083432 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Breath awareness and M kara chanting on Anxiety |
|
Scientific Title of Study
|
The effect of Breath awareness and M kara chanting in individual with Anxiety: 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 Meghansh Gautam |
| Designation |
Junior Resident |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences |
| Address |
Department of Yoga
First Floor
SDM College of Naturopathy and Yogic Sciences, Ujire, Dakshina Kannada, Karnataka - 574240
Dakshina Kannada KARNATAKA 574240 India |
| Phone |
08826394625 |
| Fax |
|
| Email |
drmeghansh01@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Bindu Shridhar |
| Designation |
Associate Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences |
| Address |
SDM College of Naturopathy and Yogic Sciences, Ujire, D.K., karnataka
Dakshina Kannada KARNATAKA 574240 India |
| Phone |
8277614169 |
| Fax |
|
| Email |
bindu.shridhar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr MEGHANSH GAUTAM |
| Designation |
Junior Resident |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences |
| Address |
Department of Yoga
First Floor
SDM College of Naturopathy and Yogic Sciences, UJire, D.K., Karnataka
Dakshina Kannada KARNATAKA 574240 India |
| Phone |
08826394625 |
| Fax |
|
| Email |
drmeghansh01@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Naturopathy and Yogic Sciences, Ujire, D.K., Karnataka- 574240 |
| Shanthivana, SDM Yoga and Nature Cure Hospital, Ujire, D.K., Karnataka-574240, |
|
|
Primary Sponsor
|
| Name |
Meghansh Gautam |
| Address |
A-154, Gali No. 12, Kh. No. 98/1/2, Wazirabad, Delhi- 110084 |
| Type of Sponsor |
Other [Self Sponsor] |
|
|
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 Meghansh Gautam |
SDM College of Naturopathy and Yogic Sciences |
Department of Yoga,
First Floor
SDM College of Naturopathy and Yogic Sciences, Ujire, Dakshina Kannada, Karnataka - 574240 Dakshina Kannada KARNATAKA |
8826394625
drmeghansh01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Breath Awareness |
Sit relaxed in any comfortable meditative posture , close your eyes and keep both hands in chin mudra then slowly start to focus on your breathing and try to be aware of the breathing patterns, the depth of breathing, the frequency of breathing, the rhythm of breathing . Practice this for 15 mins
|
| Intervention |
M Kara Chanting |
Sit in any comfortable meditative posture close your eyes keep both hands in chin mudra. First take few deep breaths and then inhale and while exhaling chant M kara
Practice this for 15 mins |
| Comparator Agent |
Supine Rest |
Patients will rest in supine position for 15 mins |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants with symptoms of Anxiety
2. Participants not on any medications
3. Participants who are ready to practice yogic techniques
4. Participants who have Scored more than 100 out of 340 in ANXIETY SYMPTOMS QUESTIONNAIRE (ASQ)
|
|
| ExclusionCriteria |
| Details |
1. Participants aged below 17 and more than 25
2. Participants on any medications
3. Participants who are already enrolled in any other yogic intervention
4. Participants who scored less than 100 in ANXIETY SYMPTOMS QUESTIONNAIRE (ASQ)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Anxiety Symptoms Questionnaire scores |
The scores will be checked on baseline and 10th day of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Anxiety on Visual Analogue Scale |
It will be checked at baseline, at 5th day & at 10th day of 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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/10/2026 |
| Date of Study Completion (India) |
27/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="2" 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
|
Yoga is an ancient practice for maintaining health at physical, mental, emotional, spiritual and intellectual levels. Yoga includes Yama, niyama, kriyas, asanas, pranayama, pratyahara, dharna, dhyana, samadhi. Yoga plays a major role in management of anxiety, as anxiety is the most common mental health disorder and becoming a global threat with rapid increase in its prevalence. The purpose of this study is to find short and effective ways of managing anxiety in day-to-day life. This study aims to see the effect of breath awareness and ‘M’ kara chanting on anxiety. To access the efficiency of breath awareness and ‘M’ kara chanting in managing anxiety. To access the effect of breath awareness and ‘M’ kara chanting on general well-being and quality of life of participation. The study is a randomized controlled trial with a sample size of 60 including both males and females of age 17 to 25 years. The sample will be randomized into two equal groups of 30 participants by help of computer-generated randomization. Intervention group will receive breath awareness and ‘M’ kara chanting’s for 15 mins each and control group will receive supine rest for 15 mins for the period of 10 days. The Anxiety Symptoms Questionnaire and Visual Analogue Scale will be administered at baseline and at 10th day. The data will be collected, and result will be drawn based on p value by using t test.Outcomes will be Improvements in psychological well-being, quality of life, overall mental health alleviation are anticipated in case groups, even with the short duration of intervention and Comparative efficacy will be determined to see if yogic techniques like breath awareness and ‘M’ kara chanting’s are superior in managing anxiety related health outcomes over a short period of time. |