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CTRI Number  CTRI/2025/03/082918 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 17/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Single Arm Study 
Public Title of Study   EFFECT OF SHVASA KRIYA ON THE NON-SPECIFIC CHRONIC LOW BACK PAIN INDIVIDUALS 
Scientific Title of Study   IMMEDIATE EFFECT OF SHVASA KRIYA ON HEART RATE VARIABILITY AND ELECTROMYOGRAPHY IN NON-SPECIFIC CHRONIC LOW BACK PAIN PATIENTS - A QUASI EXPERIMENTAL STUDY 
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 Laishram Nungshirthoi Chanu 
Designation  MD (Clinical Yoga) Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic sciences 
Address  Department of Yoga and Therapeutics, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire Belthangady Dakshina kannada Karnataka India 574240

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9366692021  
Fax    
Email  laishramchanumachathoi233@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Laishram Nungshirthoi Chanu 
Designation  MD (Clinical Yoga) Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic sciences 
Address  Department of Yoga and Therapeutics, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire Belthangady Dakshina kannada Karnataka India 574240

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9366692021  
Fax    
Email  laishramchanumachathoi233@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashwin V P 
Designation  ASSISTANT PROFESSOR 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences 
Address  Department of Yoga and Therapeutics, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire Belthangady Dakshina kannada Karnataka India 574240

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9538372524  
Fax    
Email  ashwin09@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara Yoga and Nature cure Hospital, shantivana, Dharmasthala, Belthangadi, Dakshina kannada, karnataka, India - 574216  
 
Primary Sponsor  
Name  Dr Laishram Nungshirthoi Chanu 
Address  SDM College of Naturopathy and Yogic Sciences, Ujire, Belthangadi, Dakshina kannada, india - 574240 
Type of Sponsor  Other [Self] 
 
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 Laishram Nungshirthoi Chanu  Sri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital, shantivana   COE Department of Yoga and Therapeutics Shantivana, Dharmasthala, Belthangadi, Dakshina Kannada, Karnataka, India - 574216 Dakshina Kannada KARNATAKA
Dakshina Kannada
KARNATAKA 
9366692021

laishramchanumachathoi233@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Institutional Ethical Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M545||Low back pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
Intervention  Shvasa kriya  shvasa kriya protocol will be practiced by all the subjects for 30 minutes. it is combination of asanas and breathing exercises. it has i. Hand in and out breathing, ii. Hand stretch breathing, iii. Ankle stretch breathing, iv. Straight leg raising breathing (alternate legs), v. Setu -bandha sarvangasana, vi. . Bhujangasana (cobra pose), vii. Salabhasana, viii. Sasankasana breathing, ix. Tiger stretch breathing, x Rabbit breathing 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  History of CLBP of more than 3 months.
Both male and female patients.
Pain in the lumbar spine with or without radiating pain on the leg.
Age 30-60 years 
 
ExclusionCriteria 
Details  Had performed yoga in the previous 6 months
Cannot get off the floor unaided
Has a life-threatening comorbid condition
Previously undergone spinal surgery
Had a severe documentary psychiatric problem 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Electromyography (EMG)
Heart Rate Variability 
pre, post 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 1 
Date of First Enrollment (India)   10/04/2025 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Low back pain (LBP) is a significant global health issue, affecting millions and expected to rise substantially by 2050, making it the leading cause of disability worldwide. Chronic LBP is associated with alterations in the nervous system, particularly in the corticostriatal circuitry and mesolimbic brain structures, leading to increased activity in cognitive-emotional areas such as the prefrontal cortex, amygdala, and insula. It also affects heart rate variability (HRV), reflecting changes in cardiac autonomic regulation, and impacts muscle function, which can be assessed using electromyography (EMG). Yoga, specifically pranayama, has been recognized for its benefits in improving physical, psychological, and neurophysiological health. Pranayama enhances breathing patterns, increasing oxygen levels and aiding recovery. This study aims to investigate the impact of Shvasa Kriya, a breathing technique involving body movement, on patients with non-specific chronic lower back pain, hypothesizing that it will lead to improvements in heart rate, muscle function, and coordination.

 
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