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CTRI Number  CTRI/2023/03/050430 [Registered on: 07/03/2023] Trial Registered Prospectively
Last Modified On: 09/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Immediate effect of yoga on memory and internal awareness in patients with migraine headache 
Scientific Title of Study   IMMEDIATE EFFECT OF VISUAL YOGIC RESPIRATORY BIOFEEDBACK ON VISUOSPATIAL COGNITION AND CARDIAC INTEROCEPTION IN MIGRAINEURS: A RANDOMIZED CONTROLLED TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Krithika A Ramaswamy 
Designation  PG Scholar MD Yoga 
Affiliation  SDM College of Naturopathy and Yogic Sciences 
Address  1st floor Division of Yoga and Physical theraputics SDM college of Naturopathy and Yogic sciences Ujire Belthangady Dakshin kannada district Karnataka state

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9448605748  
Fax    
Email  krithika@ramaswamy.net  
 
Details of Contact Person
Scientific Query  
Name  Dr Shivaprasad Shetty 
Designation  Dean and Division of Yoga and Physical theraputics 
Affiliation  SDM College of Naturopathy and Yogic Sciences 
Address  1st floor Division of Yoga and Physical theraputics SDM college of Naturopathy and Yogic sciences Ujire Belthangady Dakshin kannada district Karnataka state

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9731854585  
Fax    
Email  researchofficer@sdmbnys.in  
 
Details of Contact Person
Public Query  
Name  Dr Shivaprasad Shetty 
Designation  Dean and Division of Yoga and Physical theraputics 
Affiliation  SDM College of Naturopathy and Yogic Sciences 
Address  1st floor Division of Yoga and Physical theraputics SDM college of Naturopathy and Yogic sciences Ujire Belthangady Dakshin kannada district Karnataka state

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9731854585  
Fax    
Email  researchofficer@sdmbnys.in  
 
Source of Monetary or Material Support  
SDM Yoga and Naturecure hospital Shanthivana Dharmasthala 
 
Primary Sponsor  
Name  Dr Krithika A Ramaswamy 
Address  SDM Yoga and Nature cure hospital Shanthivana Dharmasthala 574216 Dakshin kannada district Karnataka 
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 Krithika A Ramaswamy  Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences  Ground Floor, Centre of excellence for clinical research centre in Naturopathy and Yogic sciences by ministry of AYUSH,GOI. Rishyashrunga Building, Department of Research, Shanthivana Yoga and Naturecure Hospital, Dharmasthala, Dakshina Kannada, KARNATAKA
Dakshina Kannada
KARNATAKA 		 9448605748

krithika@ramaswamy.net 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sri Dharmasthala Manjunatheshwara college of Naturopathy and Yogic sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G430||Migraine without aura,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Documentary Viewing  Participants in the control group will be asked to watch a documentary film for a duration of 20 minutes. 
Intervention  Visual Yogic Respiratory Biofeedback  The participants’ respiration will be assessed by attaching a respiratory effort transducer about 8cm above the lower coastal margin. Care will be taken to tighten the transducer in such a way that full inspiration is not hindered. The transducer will be connected to an 8-channel data acquisition system “Power Lab 15T” by AD instrument, Australia. The respiratory waveform will be presented on the screen as visual biofeedback. Participants will be asked to use the visual biofeedback to guide their rate and depth of breathing Participants will be instructed to perform alternate nostril yoga breathing (ANYB or nadishuddhi pranayama) at the rate of 6 breaths/min with emphasis on deep abdominal breathing for a total of 20 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. A score of ≥4 in the Migraine Screening Questionnaire (MS-Q)
2. Age between 18 to 60 years
3. History of migraine of at least 5 years
4. At least 12 migraine attacks in the last year
5. A score of ≤ 25 on the Montreal Cognitive Assessment (MoCA)
 
 
ExclusionCriteria 
Details  1. Migraine with aura
2. Individuals with any other co-existing types of headaches
3. Other neurological diseases
Presence of psychiatric co-morbidity
3. Consumption of psychotropic drugs, including migraine prophylactics
4. Consumption of caffeine or other stimulants 24 hours prior to the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Visuospatial Cognition  Baseline and immediately after intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Interoception  Baseline and immediately after intervention 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/04/2023 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 Migraine is a complex neurological condition that impacts a large proportion of the human population across all geographic locations and cultures. Current conventional management for migraine focuses more on headache relief. The clinical symptoms of migraine-related cognition are key evidence of functional brain abnormalities underlying migraine pathogenesis. Hence, improvement of cognitive function and interoception should be valued as therapeutic targets as they may aid in improving the quality of life and minimise loss of productivity in migraineurs.
The use of visual respiratory feedback may help hasten the learning process of the patient. At the same time, it also enables the treating yoga physician to objectively monitor the patient’s breathing pattern. Hence this study is undertaken to assess the efficacy of visual yogic respiratory biofeedback on visual and spatial memory and cardiac interoception in patients with migraine without aura.
 
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