| CTRI Number |
CTRI/2025/07/090878 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Exploring Natural Ways to Ease Tinnitus: Yoga and Ayurveda |
|
Scientific Title of Study
|
Assessing the efficasy of Yog and Ayurveda
in Alleviating Tinnitus Symptoms |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishwambhar Singh |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of otorhinolaryngology ,IMS BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09452970603 |
| Fax |
|
| Email |
singhvishwambhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vishwambhar Singh |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of otorhinolaryngology ,IMS BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09452970603 |
| Fax |
|
| Email |
singhvishwambhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vishwambhar Singh |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of otorhinolaryngology ,IMS BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09452970603 |
| Fax |
|
| Email |
singhvishwambhar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University |
| Address |
Banaras Hindu University, Varanasi Uttar Pradesh 221005 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrVishwambhar Singh |
SS Hospital, Institute of Medical Sciences, Banaras Hindu University |
Room Number 18, Department of otorhinolaryngology,IMS,BHU
Varanasi
UTTAR PRADESH |
09452970603
singhvishwambhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H833||Noise effects on inner ear, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ayurvedic Medicine with Yogic Practicess |
Sarvadi vati 2 tab BD Dipika tail 2drop LA BD Yogic Practices Bhramari AnulomVilom Balasana Shavasana
all for 6 months |
| Intervention |
Medicine with Yogic Practices |
Medicine
Tab nor tryptiline 10 mg once
pregabaline 75 mcg once
Tab ginkobiloba 120 mg per day
Yogic Practices
Bhramari
AnulomVilom
Balasana
Shavasana
all for 6 months
|
| Comparator Agent |
Modern Medicine |
Medicine Tab nor tryptiline 10 mg once pregabaline 75 mcg once Tab ginkobiloba 120 mg per day
all for 6 months |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Complaints of Tinnitus with intact tympanic membrane on PTA and no hearing loss will be included.
Patients between the ages of 12 and 70 years will be included in this study.
Patients will be enrolled irrespective of gender, religion, occupation, and socio-economic background.
|
|
| ExclusionCriteria |
| Details |
Patients not willing to participate in the study will be excluded.
Patients with Complaints of Tinnitus without an intact tympanic membrane and hearing loss will be excluded.
Patients who are not between the age groups will be excluded in this study.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary aim of study is to know the effect of integrated treatment on tinnitus. |
will be done every 1 month, 3 months, 6 months, the evaluation of the effect of the therapy will be recorded based on THI and Depression HAM-A, HAM-B |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the comparative effect of yog and conventional treatment on tinnitus.
To study the comparative effect of Ayurveda and conventional treatment on tinnitus.
To study the comparative effect of Yog and Ayurveda on tinnitus.
|
will be done every 1 month, 3 months, 6 months, the evaluation of the effect of the therapy will be recorded based on THI and Depression HAM-A, HAM-B |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
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)
|
05/08/2025 |
| 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="2"
Months="0"
Days="0" |
|
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
|
The study will be carried out in the ENT and Vikriti Vigyan department and the ENT department, Sir Sunderlal Hospital, Institute of Medical Sciences, Banaras Hindu University, Varanasi. The Patients of Tinnitus with intact of tympanic membrane will be selected randomly divided into three groups and registered for the study. After registration, the registered patient will be checked for hearing loss using PTA, Tinnitus severity using the THI in Hindi scale, a Personal Interview, and HAM-A, HAM-B for associated psychiatric co morbidity. Once the patient is confirmed, the patient will be provided with therapy as per group in which they fall.. Follow-up will be done every 1 month, 3 months, 6 months, and after the completion of the stipulated time, the patient will be reviewed again and the THI score will be re-calculated. Written consent will be taken from the patient participating in the study.
Follow-Up- will be done every 1 month, 3 months, 6 months, the evaluation of the effect of the therapy will be recorded based on THI and Depression HAM-A, HAM-B Duration – 30 Minutes Period – 2 Years Group1 Medicine with Yogic Practices Tab nor tryptiline 10 mg once pregabaline 75 mcg once Tab ginkobiloba 120 mg per day
Yogic Practices Bhramari Anulom Vilom Balasana Shavasana
Group2 Ayurvedic Medicine with Yogic Practicess Sarvadi vati 2 tab BD Dipika tail 2drop LA BD
Yogic Practices Bhramari AnulomVilom Balasana Shavasana
Group3 Modern Medicine
Tab nor tryptiline 10 mg once pregabaline 75 mcg once Tab ginkobiloba 120 mg per day
|