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CTRI Number  CTRI/2025/06/089527 [Registered on: 25/06/2025] Trial Registered Prospectively
Last Modified On: 24/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Karnapoorana in Ringing Sound Of The Ear 
Scientific Title of Study   A Comparative Clinical Study To Evaluate The Efficacy Of Sarshapa Taila And Guduchi Bala Taila Karnapoorana In Karnanada W.S.R To Tinnitus  
Trial Acronym  Tinnitus  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vijaylaxmi Basavaraj Chikamath  
Designation  M S(Shalakya tantra) 2nd year  
Affiliation  Shri Vijay Mahantesh Ayurvedic Medical College Ilkal 587 District-Bagalkot State-Karnataka  
Address  Shri Vijay Mahantesh Ayurvedic College And Research Centre R P Karadi Ayurvedic Hospital Department Of ENT Ground Floor Room No 2 Taluk-Ilkal District-Bagalkot State-Karnataka. Country-India Pin Code-587125

Bagalkot
KARNATAKA
587125
India 
Phone  9480857298  
Fax  00000  
Email  vbchikkamath2000@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vinod M Jadhav  
Designation  BAMS MS (Ph D) 
Affiliation  Shri Vijay Mahantesh Ayurvedic Medical College Ilkal 587 District-Bagalkot State-Karnataka  
Address  Shri Vijay Mahantesh Ayurvedic College And Research Centre R P Karadi Ayurvedic Hospital Department Of ENT Ground floor,Room Number 2 Taluk-Ilkal District-Bagalkot State-Karnataka Country-India Pin Code-587125

Bagalkot
KARNATAKA
587125
India 
Phone  7204343105  
Fax  00000  
Email  vinu2966@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vijaylaxmi Basavaraj Chikamath  
Designation  M S(Shalakya tantra) 2nd year  
Affiliation  Shri Vijay Mahantesh Ayurvedic Medical College Ilkal 587 District-Bagalkot State-Karnataka  
Address  Shri Vijay Mahantesh Ayurvedic College And Research Centre R P Karadi Ayurvedic Hospital Department Of ENT Ground Floor Room No 2 Taluk-Ilkal District-Bagalkot State-Karnataka. Country-India Pin Code-587125

Bagalkot
KARNATAKA
587125
India 
Phone  9480857298  
Fax  00000  
Email  vbchikkamath2000@gmail.com  
 
Source of Monetary or Material Support  
Shri Vijay Mahantesh Ayurvedic College And Research Centre R P Karadi Ayurvedic Hospital Ilkal Taluk Bagalkot District Karnataka State India Country Pin Code 587125 
 
Primary Sponsor  
Name  Dr Vijaylaxmi Basavaraj Chikamath  
Address  Shri Vijay Mahantesh Ayurvedic College And Research Centre Taluk-Ilkal District-Bagalkot State- Karnataka Country-India Pin Code-587125 
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 Vijaylaxmi Basavaraj Chikamath   Shri Vijay Mahantesh Ayurvedic College And Research Centre R P Karadi Ayurvedic Hospital   Mahanta Gangotri Campus Department Of ENT Ground Floor Room no 2 Ilkal Taluk Bagalkot District Karnataka State Pin Code 587125
Bagalkot
KARNATAKA 		 9480857298

vbchikkamath2000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shri Vijay Mahantesh Ayurvedic Medical College Ilkal 587125  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-Karnapoorana (Procedure Reference: Sharangdhar samhita , Procedure details: Taila is massaged around the pinna followed by mild fomentation then the taila is poured upto conchae of ear and kept for 15 minutes )
(1) Medicine Name: Sarshapa Taila , Reference: Ashtanga Hridaya commentary By Kaviraj Atridev Karna roga pratisheda adhyaya Page number 696, Route: Otic, Dosage Form: Taila, Dose: 6(ml), Frequency: od, Duration: 7 Days
(2) Medicine Name: GuduchiBala Taila , Reference: D Sreeman Namboothiri Chikitsa Manjari Vidyarambham Publishers 7th edition 2013 chapter 55 page number 496 to 497, Route: Otic, Dosage Form: Taila, Dose: 6(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients having classical lakshana of Karnanada
2) Patients having signs and symptoms of subjective Tinnitus
3) Patients of Tinnitus having chronicity upto 1year
4)Fit for Karnapoorana  
 
ExclusionCriteria 
Details  1) Perforation of tympanic membrane
2) Patient of otosclerosis and CSOM
3)Blockage due to stenosis of external auditory canal.
4) Tinnitus due to ototoxic factors
5)Glomous tumour,Aneurysm of carotid artery,Palatal myoclonus, tumour of auditory nerve. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Signs and Symptoms of Tinnitus reduced  7 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
Ringing sounds Impaired hearing and Loss of sleep improved  7 DAYS  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   10/07/2025 
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="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Sarshapa Taila And GuduchiBala Taila Karnapoorana will be done to 30 patients of Karnanada in randomised manner,
As we know that Sarshapa Taila is a standard for Karnanada,we have choosen to compare the standard group with other formulation called GuduchiBala Taila In this Trial work.
 
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