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CTRI Number  CTRI/2025/04/083919 [Registered on: 02/04/2025] Trial Registered Prospectively
Last Modified On: 01/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Managment of Tinnitus through Ayurveda. 
Scientific Title of Study   A Randomized Open Labelled Comparative Clinical Study to Evaluate the Efficacy of Madhukadi Tail Karnapoorna and Apamargkshar Tail Karnapoorna along with Goghrita orally in the Management of Karnanada (Tinnitus) 
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 AARTI KUMARI 
Designation  MS SHALAKYA TANTRA PG SCHOLAR  
Affiliation  INSTITUTE FOR AYURVED STUDIES AND RESEARCH SHRI KRISHNA AYUSH UNIVERSITY , KURUKSHETRA HARYANA  
Address  OPD NO 50, PG DEPARTMENT OF SHALAKYA TANTRA,INSTITUTE FOR AYURVED STUDIES AND RESEARCH,SHRI KRISHNA AYUSH UNIVERSITY SECTOR 8 UMRI ROAD KURUKSHETRA HARYANA

Kurukshetra
HARYANA
136118
India 
Phone  7404088194  
Fax    
Email  aartichahal77@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashu 
Designation  HOD and Chairperson  
Affiliation  Institute for Ayurved Studies and Research  
Address  Room no-108. 1st floor , Department of Shalakya Tantra, Institute for Ayurved Studies and Research, Shri Krishna Ayush University Umri Road Sector-8, Kurukshetra

Kurukshetra
HARYANA
136118
India 
Phone  9416553131  
Fax    
Email  drashukataria@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR AARTI KUMARI 
Designation  MS SHALAKYA TANTRA PG SCHOLAR  
Affiliation  INSTITUTE FOR AYURVED STUDIES AND RESEARCH SHRI KRISHNA AYUSH UNIVERSITY , KURUKSHETRA HARYANA  
Address  OPD NO 50, PG DEPARTMENT OF SHALAKYA TANTRA,INSTITUTE FOR AYURVED STUDIES AND RESEARCH,SHRI KRISHNA AYUSH UNIVERSITY SECTOR 8 UMRI ROAD KURUKSHETRA HARYANA

Kurukshetra
HARYANA
136118
India 
Phone  7404088194  
Fax    
Email  aartichahal77@gmail.com  
 
Source of Monetary or Material Support  
Department of Shalakya Tantra, Institute For Ayurved Studies Research Shri Krishna Ayush University Sec 8 Umri road 136118 Kurukshetra Haryana 
 
Primary Sponsor  
Name  Institute For Ayurved Studies Research Shri Krishna Ayush University Kurukshetra Haryana 
Address  Institute For Ayurved Studies Research Shri Krishna Ayush University Sec 8 Umri road 136118 Kurukshetra Haryana 
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 
DR AARTI KUMARI  Institute For Ayurved Studies & Research, Shri Krishna Ayush University Kurukshetra, Haryana  OPD NO 50, PG DEPARTMENT OF SHALAKYA TANTRA,INSTITUTE FOR AYURVED STUDIES AND RESEARCH,SHRI KRISHNA AYUSH UNIVERSITY SECTOR 8 UMRI ROAD 136118 KURUKSHETRA HARYANA
Kurukshetra
HARYANA 
07404088194

aartichahal77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SHRI KRISHNA AYUSH UNIVERSITY 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. Ayurveda Condition: KARNA-NADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-karNapUraNam, कर्णपूरणम् (Procedure Reference: Sharangdhar samhita, Procedure details: Karnapoorana is a procedure in which luke warm Apamargkshar tail is slowly poured into the affected ear(till EAC fills). This procedure begins with an ear and partial head massage. Duration of the procedure is 100 matra kala.))
(1) Medicine Name: Apamargkshar tail, Reference: Sharangdhar samhita, Route: Otic, Dosage Form: Taila, Dose: 15(drops), Frequency: od, Duration: 30 Days
(2) Medicine Name: Goghrit, Reference: Sushrut Samhita, Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: hs, Duration: 30 Days
2Intervention ArmProcedure-karNapUraNam, कर्णपूरणम् (Procedure Reference: Sharangdhar samhita, Procedure details: Karnapoorana is a procedure in which warm Madhukadi tail is slowly poured into the affected ear(till EAC fills). This procedure begins with an ear & partial head massage. Duration of the procedure is 100 matra kala.)
(1) Medicine Name: Madhukadi tail, Reference: Bhaisajya Ratnavali, Route: Otic, Dosage Form: Taila, Dose: 15(drops), Frequency: od, Duration: 30 Days
(2) Medicine Name: Goghrit, Reference: Sushrut samhita, Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: hs, Duration: 30 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients between the age of 16-60 years irrespective of age, sex, caste, religion etc.
2. Patients will be selected based on symptoms of Karnanada (Tinnitus).
3. Subjective type of tinnitus.
4. Tinnitus without vertigo. 
 
ExclusionCriteria 
Details  1. Patients of age less than 16 years and more than 60 years
2. Patients suffering from any chronic debilitating disease like DM, HTN, KOCH’S
and with other ear pathologies.
3. Objective type of Tinnitus.
4. Cases of tinnitus which required surgical intervention.
5. CSOM, Otomycosis, Perforated TM.
6. Pregnant and Immuno-compromised patients
7. Tinnitus associated with disease like – any growth of middle ear, Aneurysms of the carotid
artery, palatal myoclonus, Meniere’s disease and meningitis.
8. Degree of hearing loss greater than 40 dB.
9. Drug induced tinnitus e.g. high dose aspirin, ibuprofen, diclofenac etc.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in karnanada symptoms and objective parameters like masking test for tinnitus and audiometry  60 days 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life will be improved. Decrease in Tinnitus Handicap Inventory score Improvement in mild hearing loss  60 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   20/04/2025 
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="1"
Months="6"
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  
As epidemiological studies have shown, tinnitus is a common problem for millions of people reports its prevalence to be between 8 and 25.3% of the United States population. Similar findings were made by population studies conducted in other countries prevalence of tinnitus ranging from 4.6% to 30%. This disorder in India is with a prevalence of more than 7% of the Indian population. It is serious, it affects the quality of life of about 1-3% of the world. Tinnitus affects 10 to 15% of adults’ general population. About 20% of the tinnitus population requires serious clinical. Tinnitus Awareness Week was between 5 and 11 February 2024. Aim of this campaign was to educate and raise awareness of tinnitus, provide support to those affected and promote research into effective treatment. The treatments available for tinnitus are varied. The ultimate proof for clinical efficacy is available for cognitive- behavioral therapies. Further established treatment includes counseling and various forms of sound therapy along with methods that attempt to increase input to the auditory system such as hearing aids and masking Tinnitus, sedation and tranquilizers. Despite its prevalence and impact on quality of life there are no evidence- based guidelines for the treatment of tinnitus to date, and therefore presents a challenge to find such drugs or therapies in alternative systems of medicine. Ayurveda has a systematic line of treatment under the management of Karnanada. Line from treatment in Ayurveda for four diseases viz. Karnashoola, Pranada, Karnashweda and Badhirya is similar. The general line of treatment for Karnarogas is Ghritapana, Rasayana, Avyayama, Ashirasnana, Brahmacharya, Akathana. Karna is one of the Adhisthana Vata Dosha. In Ayurveda, vata is the main one dosha involved in Karnad disease. Treatment should be directed at Vatashaman and Rasayan Karnapooran which is an important therapy in karnarogas. It has a unique the quality is easily absorbed by the pores in the skin and acts on the supply their nutrition for the nerves. Therefore, in this study, Karanpoorna with Madhukadi tail and Apamargkshar Tail possessing vatahara property is selected for the study. Administration of Goghrita orally pacifies Vata and improves the strength of the nerves, it has Rasayana, Balya and Vatahara properties which can prevent age related degenerative changes in the internal ear. Hence it is proposed to undertake this study entitled “A Randomized Open Labelled Comparative Clinical Study to Evaluate the Efficacy of Madhukadi Tail
Karnapoorna and Apamargkshar Tail Karnapoorna along with Goghrita orally in the
management of Karnanada (Tinnitus)”.
 
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