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CTRI Number  CTRI/2025/01/079318 [Registered on: 23/01/2025] Trial Registered Prospectively
Last Modified On: 23/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Exploring the effect of Yoga on tinnitus relief and stress reduction  
Scientific Title of Study   The effect of Yoga intervention in subjects with tinnitus on Audiological parameters, tinnitus handicap and stress 
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 Anuradha  
Designation  Lecturer  
Affiliation  Post graduate Institute for medical education and research  
Address  Room number 4081, 4th floor , ENT department, PGIMER , sector 12 , Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9872987304  
Fax    
Email  anuradha2ks@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anuradha  
Designation  Lecturer  
Affiliation  Post graduate Institute for medical education and research  
Address  Room number 4081, 4th floor , ENT department, PGIMER , sector 12 , Chandigarh


CHANDIGARH
160012
India 
Phone  9872987304  
Fax    
Email  anuradha2ks@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Anuradha  
Designation  Lecturer  
Affiliation  Post graduate Institute for medical education and research  
Address  Room number 4081, 4th floor , ENT department, PGIMER , sector 12 , Chandigarh


CHANDIGARH
160012
India 
Phone  9872987304  
Fax    
Email  anuradha2ks@yahoo.com  
 
Source of Monetary or Material Support  
Central Council For Research In Yoga And Naturopathy, 61-65, Institutional Area, Sewa Marg, Pocket D 1A, Janakpuri, New Delhi, 110058. 
 
Primary Sponsor  
Name  Central Council For Research In Yoga And Naturopathy 
Address  61-65, Institutional Area, Sewa Marg, Pocket D 1A, Janakpuri, New Delhi, Delhi 110058 
Type of Sponsor  Government funding agency 
 
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 Anuradha  Post Graduate Institute of Medical Education and Research  Room no. 4081, Department of ENT, 4th floor, New OPD, Madhya Marg, Sector 12, Chandigarh, 160012
Chandigarh
CHANDIGARH 		 9872987304

anuradha2ks@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Postgraduate Institute of Medical Education and Research Chandigarh, Institutional Ethics committee  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 
Intervention  Integrated yoga module for tinnitus   Yoga sessions are being conducted online 6 days a week for 12 weeks, with each session lasting about an hour. Certified yoga instructors and researchers lead the classes, which include warm-ups, yoga poses, and meditation, practiced on mats. Each session begins with 15 minutes of stretching and warm-ups, followed by 30 minutes of yoga poses and 15 minutes of breathing exercises and meditation. The integrated yoga module for tinnitus follows a structured approach with breathing exercises, asanas, mudras, pranayama, meditation, and a closing prayer, totaling 60 minutes. The Intervention arm will be evaluated at baseline, 3 months and 6 month. 
Comparator Agent  Standard care   Counselling and education sessions will be given once a week for 6 weeks- Each session usually lasting an hour and conducted by audiologist trained in tinnitus care. Comparator arm will be evaluated at baseline, 3 months and 6 month. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1)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 6 weeks.
4)Subjects who will give their consent to the request of the investigator for the assessments and management.


 
 
ExclusionCriteria 
Details  1)Subjects having severe to profound hearing loss.
2)Subjects having objective tinnitus
3)Subjects having any external or middle ear pathology.
4)Subjects with history of ototoxicity.
5)Subjects with history of Ear trauma.
6)Subjects having any Organic psychiatric disease.
7)Subjects suspected of Meniere’s disease.
8)Subjects suspected of otosclerosis.
9)Subjects having acoustic neuroma I vestibular schwanomma.
10)Chronic noise exposure.
 
 
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 
To evaluate the differences in Tinnitus functionality index of these subjects before and after Yoga intervention.  baseline,3 and 6 months  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate changes in audiological characteristics, post 3 and 6 months of yoga therapy.
To measure the changes in tinnitus handicap inventory responses pre and post yoga therapy
To compare the outcomes in terms of pitch and loudness matching before and after yoga therapy
To evaluate the stress reduction on perceived stress index, Tinnitus Severity Index, tinnitus handicap questionnaire and Tinnitus Reaction Questionnaire scores.
 		 baseline , 3 and 6 months 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   03/02/2025 
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="3"
Months="0"
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  

Title: The Effect of Yoga Intervention in Subjects with Tinnitus on Audiological Parameters, Tinnitus Handicap, and Stress

Background: The perception of sound when there are no external auditory stimuli is known as tinnitus, and it has a major negative impact on quality of life. Due to the limited effectiveness of conventional treatments, interest in complementary therapies like yoga has grown. This study investigates the effects of yoga on stress levels, audiological parameters, and the severity of tinnitus.

The main goal is to assess how the Tinnitus Functional Index (TFI) in tinnitus sufferers changed before and after the yoga intervention. Assessing changes in audiological traits, responding to the Tinnitus Handicap Inventory, pitch and loudness matching, and stress reduction as determined by the Tinnitus Reaction Questionnaire (TRQ), Tinnitus Severity Index (TSI), and Perceived Stress Scale (PSS) are examples of secondary objectives.

Methods: Twenty-four tinnitus patients were included in this randomized controlled trial. They were split into two groups, one of which received a structured yoga intervention and the other was used as a control. The subjects go through extensive clinical and audiological evaluations, which include measurements of saliva cortisol for stress assessment, tinnitus matching, and pure tone audiometry. For three months, there will be weekly yoga sessions that include breathing techniques, asanas, mudras, pranayama, and meditation.

Results: This research will examine how yoga affects stress biomarkers, audiological parameters, and distress related to tinnitus. It is predicted that, in comparison to the control group, the yoga intervention will dramatically lower stress levels and the severity of tinnitus.

Conclusion: The purpose of this research is to present empirical data regarding the efficacy of yoga as a complementary therapy for the management of tinnitus, with the goal of influencing future clinical practices and healthcare policies. 
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