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CTRI Number  CTRI/2024/10/075000 [Registered on: 09/10/2024] Trial Registered Prospectively
Last Modified On: 08/10/2024
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 Yoga in people with ringing in ears (tinnitus) 
Scientific Title of Study   The Effect of Yoga Intervention in Subjects with Tinnitus on Audiological Parameters 
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 Sanjay Munjal 
Designation  Professor and Incharge  
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Room Number 4075, Speech and Hearing Unit, ENT Department, A Block, 4th Floor, New OPD, PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  09815653262  
Fax    
Email  sanjaymunjal1@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjay Munjal 
Designation  Professor and Incharge  
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Room Number 4075, Speech and Hearing Unit, ENT Department, A Block, 4th Floor, New OPD, PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  09815653262  
Fax    
Email  sanjaymunjal1@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anuradha Sharma 
Designation  Lecturer 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Room Number 4081, Speech and Hearing Unit, ENT Department, A Block, 4th Floor, New OPD, PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  9872987304  
Fax    
Email  anuradha2ks@yahoo.com  
 
Source of Monetary or Material Support  
Department of Science & Technology, Technology Bhavan, New Mehrauli Road,, New Delhi-110016. 
 
Primary Sponsor  
Name  Dr Sanjay Munjal 
Address  ENT Department, 4th Floor, A Block, New OPD, Post Graduate Institute of Medical Education and Research, Chandigarh 160012, India  
Type of Sponsor  Research institution 
 
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 Sanjay Munjal  Post Graduate Institute of Medical Education and Research  new OPD, 4th floor, A block, ENT department, Speech and Hearing Unit,room number 4075, Chandigarh
Chandigarh
CHANDIGARH 
09815653262

sanjaymunjal1@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee of PGIMER, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H838||Other specified diseases of innerear,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  control group with tinnitus (aged matched )  patients in the waiting list will not be given any treatment for tinnitus.  
Intervention  Yoga  yoga asanas along with breathing exercises, and meditation sessions will be taken by a professional yoga instructor 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Subjects having Tinnitus in the age range of 20-50 years.
2) Subjects with healthy external and middle ear on clinical examination.
3) Subjects having tinnitus for at least more than 4 weeks.
4) Subjects who will give their consent to the request of the investigator for the assessments.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
scores of tinnitus handicap inventory and Tinnitus severity index questionnaire will be compared for all patients wit tinnitus   BASELINE
3 MONTHS
6 MONTHS

 
 
Secondary Outcome  
Outcome  TimePoints 
audiological parameters
Tinnitus severity index
perceived stress scale  
baseline
3 months
6 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   N/A 
Date of First Enrollment (India)   01/11/2024 
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="3"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

summary: Tinnitus remains one of most devastating auditory handicaps. Tinnitus is any ringing sensation that can be heard by the person himself without any external stimuli being presented. People with Tinnitus often have difficulty sleeping and concentrating at work, and are annoyed and get anxious thus leading to degraded quality of life of these individuals. It has been estimated that as many as 6-20% of the population experiences a form severe enough to interfere with daily activity. Many consider or are driven to suicide. Moreover, it must be emphasized that there is a relation between Tinnitus and the activity of the prefrontal cortex and limbic system. This part of the brain is related to emotions, thus the association with depression, anxiety and other psychological diseases can be made when Tinnitus is severe hence making it the target of most of the investigations.Innumerable treatments for this condition have been utilized with varying degrees of success by clinicians and patients. The goal of effective Tinnitus management is not necessary to mask or remove the patient’s physical perception of Tinnitus associated sounds. According to Duckro et al "treatment of chronic Tinnitus is more accurately described in terms of management rather than cure"(1). A realistic goal of an effective Tinnitus management program is to help patients understand and gain control over their disease, rather than latter having control over them. Ultimately clinicians should strive to help patients progress to the point where Tinnitus is no longer a negative factor in their lives. Available treatments for management of Tinnitus are diverse. More evidence is available for cognitive-behavioural therapies. Further established treatments include counselling, various forms of sound therapies, methods that attempt to increase input to auditory system, such as hearing aids and cochlear implants, pharmacological treatments, neuro-biofeedback, various forms of electrical stimulation of brain structures, inducing electric current in brain with transcranial direct current stimulation or rTMS. However, evidence for effectiveness of these different treatment strategies is scarce. These therapies present different results among the patients due to different etiologies of Tinnitus. Therefore, a comprehensive evaluation of underlying etiology is mandatory prior to commencement of treatment. Yoga is an ancient and holistic system originated from India, which involves physical postures (asana), breathing exercises (Pranayama) and meditation (shavasana and yoganidra). Yoga has been reported to reduce sympathetic hormones, stimulate the limbic 27 system and activate antagonistic neuromuscular systems. There are various studies about the therapeutic effects of Yoga in reducing anxiety, stress, depression, sleeping disorders, insomnia and hypertension. Many studies have concluded that yoga increases the levels of GABA (gamma-amino butyric acid) which is an inhibitory neurotransmitter which inhibits the electrical activity and thus reduces tinnitus, anxiety as well as depression. Pandey et al, 2010 reported positive effects of Bhramari Pranayam which is a form of yoga in which eyelids are closed followed by relaxation posture along with humming on exhalation. It was found that there was positive effect of this yogic form on physical and emotional features of tinnitus. Thus, he concluded that this particular form of yogic form can be given to individuals who have tinnitus. A recent study done by Köksoy et al, 2022 studied the effect of yoga in patients having subjective tinnitus. Here tinnitus scores before and after yoga sessions was calculated. The scores showed significant results indicating less handicap scores, stress and severity. A systemic review done by Gunjawate et al, 2021 on five studies concluded that yoga has positive effects on tinnitus like reduced stress and anxiety and improved quality of life. All of these parameters were based on subjective parameters. However, most of the studies have not given any difference in audiological parameters. Based on this, we aim to investigate to the effect of Yoga intervention in Tinnitus patients by assessing audiological parameters. Tinnitus remains one of most devastating auditory handicaps. Tinnitus is any ringing sensation that can be heard by the person himself without any external stimuli being presented. People with Tinnitus often have difficulty sleeping and concentrating at work, and are annoyed and get anxious thus leading to degraded quality of life of these individuals. It has been estimated that as many as 6-20% of the population experiences a form severe enough to interfere with daily activity. Many consider or are driven to suicide. Moreover, it must be emphasized that there is a relation between Tinnitus and the activity of the prefrontal cortex and limbic system. This part of the brain is related to emotions, thus the association with depression, anxiety and other psychological diseases can be made when Tinnitus is severe hence making it the target of most of the investigations. Innumerable treatments for this condition have been utilized with varying degrees of success by clinicians and patients. The goal of effective Tinnitus management is not necessary to mask or remove the patient’s physical perception of Tinnitus associated sounds. According to Duckro et al "treatment of chronic Tinnitus is more accurately described in terms of management rather than cure"(1). A realistic goal of an effective Tinnitus management program is to help patients understand and gain control over their disease, rather than latter having control over them. Ultimately clinicians should strive to help patients progress to the point where Tinnitus is no longer a negative factor in their lives. Available treatments for management of Tinnitus are diverse. More evidence is available for cognitive-behavioural therapies. Further established treatments include counselling, various forms of sound therapies, methods that attempt to increase input to auditory system, such as hearing aids and cochlear implants, pharmacological treatments, neuro-biofeedback, various forms of electrical stimulation of brain structures, inducing electric current in brain with transcranial direct current stimulation or rTMS. However, evidence for effectiveness of these different treatment strategies is scarce. These therapies present different results among the patients due to different etiologies of Tinnitus. Therefore, a comprehensive evaluation of underlying etiology is mandatory prior to commencement of treatment. Yoga is an ancient and holistic system originated from India, which involves physical postures (asana), breathing exercises (Pranayama) and meditation (Shavasana and yoganidra). Yoga has been reported to reduce sympathetic hormones, stimulate the limbic 27 system and activate antagonistic neuromuscular systems. There are various studies about the therapeutic effects of Yoga in reducing anxiety, stress, depression, sleeping disorders, insomnia and hypertension. Many studies have concluded that yoga increases the levels of GABA (gamma-amino butyric acid) which is an inhibitory neurotransmitter which inhibits the electrical activity and thus reduces tinnitus, anxiety as well as depression. Pandey et al, 2010 reported positive effects of Bhramari Pranayam which is a form of yoga in which eyelids are closed followed by relaxation posture along with humming on exhalation. It was found that there was positive effect of this yogic form on physical and emotional features of tinnitus. Thus, he concluded that this particular form of yogic form can be given to individuals who have tinnitus. A recent study done by Köksoy et al, 2022 studied the effect of yoga in patients having subjective tinnitus. Here tinnitus scores before and after yoga sessions was calculated. The scores showed significant results indicating less handicap scores, stress and severity. A systemic review done by Gunjawate et al, 2021 on five studies concluded that yoga has positive effects on tinnitus like reduced stress and anxiety and improved quality of life. All of these parameters were based on subjective parameters. However, most of the studies have not given any difference in audiological parameters. 

Based on this, we aim to investigate to the effect of Yoga intervention in Tinnitus patients by assessing audiological parameters

 
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