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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  
Name  Address 
Nil  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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