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CTRI Number  CTRI/2023/01/049235 [Registered on: 25/01/2023] Trial Registered Prospectively
Last Modified On: 09/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Bilva taila karnapoorana with Brahmi ghrita orally in the management of tinnitus 
Scientific Title of Study   “A randomized open labelled controlled clinical study to evaluate the efficacy of Bilva Taila Karnapoorana with Brahmi Ghrita orally in the management of Karnanada and Karnakshweda with special reference to Tinnitus”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mohammed Irfan  
Designation  PG Scholar  
Affiliation  Sri Sri College of Ayurvedic Science and Research  
Address  Room number 305,department of PG Studies in Shalakya Tantra,Sri Sri College of Ayurvedic Science and Research 21st KM, Kanakapura Road, Udayapura Post Banglore-560082 Bangalore KARNATAKA 560082 India

Bangalore
KARNATAKA
560082
India 
Phone  8892807513  
Fax    
Email  mohammedirfan025@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Naveen B S  
Designation  Professor and HOD 
Affiliation  Sri Sri College of Ayurvedic Science and Research  
Address  Room number 305 Department of PG Studies in Shalakyatantra Sri Sri College of Ayurvedic Science and Research Hospital 21st KM Kanakapura main road Udayapura post Bengaluru 560082 Bangalore KARNATAKA

Bangalore
KARNATAKA
560082
India 
Phone  9844991405  
Fax    
Email  navs009@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Naveen B S  
Designation  Professor and HOD 
Affiliation  Sri Sri College of Ayurvedic Science and Research  
Address  Room number 305 Department of PG Studies in Shalakyatantra Sri Sri College of Ayurvedic Science and Research Hospital 21st KM Kanakapura main road Udayapura post Bengaluru 560082 Bangalore KARNATAKA

Bangalore
KARNATAKA
560082
India 
Phone  9844991405  
Fax    
Email  navs009@gmail.com  
 
Source of Monetary or Material Support  
Sri Sri College of Ayurvedic Science and Research Hospital 
 
Primary Sponsor  
Name  Dr Mohammed Irfan 
Address  Sri Sri College of Ayurvedic Science and Research 21st KM, Kanakapura Road, Udayapura Post Banglore-560082  
Type of Sponsor  Other [self] 
 
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 Mohammed Irfan  Sri Sri College of Ayurvedic Science and Research Hospital  Room number 305, Department of PG studies in Shalakya tantra,,Sri Sri College of Ayurvedic Science and Research 21st KM, Kanakapura Road, Udayapura Post Banglore-560082
Bangalore
KARNATAKA 		 8892807513

mohammedirfan025@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Sri Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H931||Tinnitus. Ayurveda Condition: KARNA-NADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-karNapUraNam, कर्णपूरणम् (Procedure Reference: Chakradatta, Procedure details: Subjects diagnosed with Karnanaada and Karnakshweda will be selected. As poorvakarma - Karna abhyanga will be done. As pradhana karma - Karna poorana with Bilva taila for 100 matra kala and as paschat karma Karna dhoopana with Haridradi varti will be done. And orally selected ghrita will be advised at night time.)
(1) Medicine Name: Bilva taila, Reference: Chakradatta, Route: Otic, Dosage Form: Taila, Dose: 24(drops), Frequency: od, Duration: 7 Days
(2) Medicine Name: Brahmi ghrita, Reference: Astanga Hrudaya, Route: Oral, Dosage Form: Ghrita, Dose: 10(g), Frequency: hs, Duration: 30 Days
2Comparator ArmProcedure-karNapUraNam, कर्णपूरणम् (Procedure Reference: Chakradatta, Procedure details: Subjects diagnosed with Karnanaada and Karnakshweda will be selected. As poorvakarma - Karna abhyanga will be done. As pradhana karma - Karna poorana with Bilva taila for 100 matra kala and as paschat karma Karna dhoopana with Haridradi varti will be done. And orally selected ghrita will be advised at night time.)
(1) Medicine Name: Bilva Taila, Reference: Chakradatta, Route: Otic, Dosage Form: Taila, Dose: 24(drops), Frequency: od, Duration: 7 Days
(2) Medicine Name: Ashwagandha Ghrita, Reference: Charaka Samhita, Route: Oral, Dosage Form: Ghrita, Dose: 10(g), Frequency: hs, Duration: 30 Days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects within the age of 21 to 60 years irrespective of gender, occupation, religion, socio- economic status and duration of illness. 1. Subjects having mild to moderate hearing loss. 2. Subjects who fulfill the diagnostic Criteria. 3. Subjects willing to participate in the study with written informed consent, which is conveyed in the language which the subject can understand. 4. Subjects with tinnitus who were not undergoing treatment for tinnitus in the last six months. 
 
ExclusionCriteria 
Details  1. Subjects having perforated tympanic membrane.
2. Subjects having any uncontrolled systemic illness which can interfere with the course of disease and treatment.
3. Subjects having congenital deformity of ear.
4. Subjects diagnosed with other diseases like tumors of ear, Aneurysms of carotid artery, Meningitis, Meniere’s disease, Acute suppurative otitis media and Chronic suppurative otitis media.
5. Subjects with hearing aids, hearing asymmetry or retro cochlear pathology, metabolic or psychiatric diseases.
6. Subjects’ incapable of filling/answering Tinnitus Handicap Inventory, Clinical Global Impression of Improvement (CGI-I) scale.
7. Pregnant and lactating women. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. karnanada (noise in the ear)
2. karnapratinaha
3.Tinnitus handicap inventory,Tinnitus Handicap Inventory SEVERITY SCALE
4.Clinical Global Impression of Improvement (CGI-I) 		 1. 0th day – Pre- study Assessment
2. 7th day – Assessment during trail period
3. 30th day - Post study assessment
4. 45th day – Drug free follow-up assessment.
 
 
Secondary Outcome  
Outcome  TimePoints 
Pure tone audiometry  Pure tone audiometry will be done on 0th day and 45th day. 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/02/2023 
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)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Karnanada is one among the Karna Rogas. Vata Dosha entering into Karna by Vimarga Gamana or encircled by Kaphadi Doshas (Sanga) in Sabdavaha Srotas, produces different types of sounds in the ear like that of Bheri (kettle drum), Mrudanga (a kind of drum), Shankha (conch shell) in Karnanada and Venughosha (flute like sound) in Karnakshweda. In contemporary science, the signs and symptoms of Karnanada and Karnakshweda can be correlated with Tinnitus. Tinnitus is characterized by the perception of sound in the absence of an external stimulus. Following a recent multidisciplinary consensus, tinnitus is termed as the conscious awareness of a tonal or composite noise for which there is no identifiable corresponding external acoustic source. The use of Sneha especially Taila helps to subside Vata Dosha and clears the Srotas of the Karna.  Hence in the present study, an effort will be made to evaluate comparative efficacy of Bilva Taila Karnapoorana12 with Brahmi Ghrita13orally and Bilva Taila Karnapoorana with Ashwagandha Ghrita orally in the management of Karnanada and Karnakshweda with special reference to Tinnitus.  
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