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CTRI Number  CTRI/2019/03/017995 [Registered on: 08/03/2019] Trial Registered Retrospectively
Last Modified On: 06/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   YOGA AND PHYSIOTHERAPY ON vertigo 
Scientific Title of Study   EFFICACY OF YOGA AND PHYSIOTHERAPY ON VESTIBULAR DISORDER- A RANDOMISED 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  VAISHALI K 
Designation  Professor Head 
Affiliation  School of Allied Health Sciences, Manipal Academy of Higher Education 
Address  Department of Physiotherapy School of Allied Health Sciences MAHE Manipal
MANIPAL
Udupi
KARNATAKA
576104
India 
Phone  9483625754  
Fax    
Email  vaishali.kh@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  VAISHALI K 
Designation  Professor Head 
Affiliation  School of Allied Health Sciences,Manipal Academy of Higher Education 
Address  Department of Physiotherapy School of Allied Health Sciences MAHE Manipal

Udupi
KARNATAKA
576104
India 
Phone  9483625754  
Fax    
Email  vaishali.kh@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Vaishali k 
Designation  Professor Head 
Affiliation  School of Allied Health Sciences,Manipal Academy of Higher Education 
Address  Department of Physiotherapy School of Allied Health Sciences MAHE Manipal

Udupi
KARNATAKA
576104
India 
Phone  9483625754  
Fax    
Email  vaishali.kh@manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education 
Address  Manipal Academy of Higher Education DIS- UDUPI STATE- KARNATAKA  
Type of Sponsor  Research institution and hospital 
 
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 
VAISHALI   kasturba medical college mangalore  Department of physiotherapy kasturba medical college mangalore
Dakshina Kannada
KARNATAKA 		 9483625754

vaishali.kh@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE,KMC, MANGALORE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  chronic peripheral vestibular vertigo of at least one year duration not cured by medications, (1) ICD-10 Condition: H830||Labyrinthitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control  All patients were treated with Prochlorperazine (Stemetil MD) 5-10 mg three to four times daily starting from the least dose to increasing doses that was necessary to control the symptom. 
Intervention  Vestibular rehabilitation program   I. A. Promote use of VOR and COR for gaze stability B. Encourage vestibular adaptation by inducing retinal slip. II. Promote use of saccadic eye movement for gaze stability III. Encourage resetting of VOR gain at various head speeds IV. Improve ability to utilize somatosensory & vestibular input for postural control V. The vestibulo-spinal system VI. Improve ability to utilize vestibular and visual input for postural control VII. Improve dynamic postural control utilizing all sensory input VII. Moving about IX. Other exercises:  
Intervention  YOGA TECHNIQUES  twelve week course of yoga techniques. During the first week, patients attended a series of 30-45 minute yoga sessions Subsequently the patients were instructed to continue the prescribed yoga techniques once a day for 11 weeks at home independently. Subjects were provided with an audio cassette regarding the instructions for performing the asanas. Further written format of yoga techniques was provided to the subjects. Yoga techniques employed 1.Svastikāsana, 2.Vajrāsana, 3.Sputa vajrāsana, 4.Tādāsana 5. Pada hastasana 6. Trikonāsana 7. Parsvakonasana 8. Parshvottanasa 9. Virabhadrasana 10. Pooravothanasana 11. Paschimothanasana 12. Pavanamuktasana 13. Makarāsana 14. Bhujangasana 15. Navasana (The Boat Pose) 16. Uttanapadasana 17. Ujjayi pranayamaAnuloma viloma pranayama 18. Trataka (concentrated gazing) 19. Savasana 1  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients with chronic peripheral vestibular vertigo of at least one year duration not cured by medications were included in the study with diagnosis of Benign Positional Paroxysmal Vertigo, Labyrinthitis, Vestibular Neuronitis, Meniere’s disease, local trauma.  
 
ExclusionCriteria 
Details  Patients with vertigo due to middle ear causes like effusions, perilymphatic fistula, Otosclerosis and Mastoiditis were excluded from the study. Patients with central vertigo, basilar artery insufficiency and chronic undiagnosed vertigo  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual analogue scale (VAS)
Vertigo symptom scale (VSS)
Dizziness Handicap Inventory (DHI)
SF-36 		 Visual analogue scale (VAS)
Vertigo symptom scale (VSS)
Dizziness Handicap Inventory (DHI)
Vestibular disorder Activity of Daily Living scale (VADL)
SF-36 
 
Secondary Outcome  
Outcome  TimePoints 
Vestibular disorder Activity of Daily Living scale (VADL)  4 times 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "144"
Final Enrollment numbers achieved (India)="144" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/08/2009 
Date of Study Completion (India) 28/09/2012 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 28/09/2012 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Yet to publish 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Objective: To compare the efficacy of Yoga as a vestibular rehabilitation exercise with the traditional Vestibular Rehabilitation Therapy (VRT).

Design: observer blinded randomized controlled trial

Setting:This study was conducted in the academic department of Otolaryngology – Head & Neck Surgery, Kasturba Medical College, Mangalore, a coastal city in South India.

 Subjects: The inclusion of 150 participants in the study was based on 18 point difference in the DHI score.

Interventions: Randomly assigned into three groups. Yoga was categorized as Group I, VRT as Group II and those with medication as Group III through block randomization.

Main outcome measures: Dizziness Handicap Inventory(DHI)  was completed three times at the beginning,end of  the fourth week, eight weeks and twelfth week). SF 36 was assessed initially and end of twelve weeks.

The results: Data of 150 patients were analyzed. The mean DHI and  mean SF-36 decreased significantly in both the yoga and VRT but there was no significant reduction in the generic quality of life in the control group when compared to baseline.

Conclusion: The advantage of yoga over  VRT is that is provides a wholesome and customized cure for giddiness. That means, apart from providing symptomatic relief of giddiness by vestibular rehabilitation, yoga also brings in additional proven benefits like general body relaxation, increased blood oxygenation, detoxification and an overall sense of well being. Being cheap and easy to learn, yoga could be an excellent substitute to the traditional VRT .

 
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