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CTRI Number  CTRI/2024/10/075407 [Registered on: 17/10/2024] Trial Registered Prospectively
Last Modified On: 16/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   An Ayurvedic Management of Ringing Sound In The Ear(Tinnitus) 
Scientific Title of Study   A Comparative Clinical Study To Evaluate The Efficacy Of Karnavatahara Taila Karnapoorana And Ksheerabala Taila Karnapoorana In The Management Of Karnanada 
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 Shreya Kamat 
Designation  PG Scholar 
Affiliation  Govt Ayurveda Medical College, Bengaluru  
Address  Department Of PG Studies In Shalakya Tantra, Shalakya Tantra Opd No.11, Govt Ayurveda Medical College, Dhanwantari Road, Bengaluru

Bangalore
KARNATAKA
560009
India 
Phone  7406247178  
Fax    
Email  kamatshreya24@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rathi S 
Designation  Professor 
Affiliation  Govt Ayurveda Medical College, Bengaluru  
Address  Department Of PG Studies In Shalakya Tantra, Shalakya Tantra Opd No.11, Govt Ayurveda Medical College, Dhanwantari Road, Bengaluru

Bangalore
KARNATAKA
560009
India 
Phone  8970779550  
Fax    
Email  drrathi.s@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shreya Kamat 
Designation  PG Scholar 
Affiliation  Govt Ayurveda Medical College, Bengaluru  
Address  Department Of PG Studies In Shalakya Tantra, Shalakya Tantra Opd No.11, Govt Ayurveda Medical College, Dhanwantari Road, Bengaluru

Bangalore
KARNATAKA
560009
India 
Phone  7406247178  
Fax    
Email  kamatshreya24@gmail.com  
 
Source of Monetary or Material Support  
Dr Shreya Kamat, Sri Jayachamarajendra Government Ayurveda And Unani Hospital, Government Ayurveda Medical College, Dhanwantari Road, Bengaluru-560009, Karnataka, India 
 
Primary Sponsor  
Name  Dr Shreya Kamat 
Address  OPD no.11, ENT division, Department of Shalakya Tantra,Government Ayurveda Medical College, Dhanwantari road, Bengaluru-560009, Karnataka, India 
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 Shreya Kamat   Sri Jayachamarajendra Government Ayurveda And Unani Hospital, Bengaluru  Department of PG Studies in Shalakya Tantra, Shalakya Tantra OPD Room No.11, ENT Division, Govt Ayurveda Medical College, Dhanwantari Road, Bengaluru
Bangalore
KARNATAKA 		 7406247178

kamatshreya24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Sri Jayachamarajendra Ayurveda and Unani Hospital, Dhanwantari road, Bengaluru-560009, Karnataka, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H839||Unspecified disease of inner ear. Ayurveda Condition: KARNA-NADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Karnavatahara taila, Reference: Basavarajeeyam, Route: Otic, Dosage Form: Taila, Dose: 8(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Retention of lukewarm taila in external auditory canal
2Comparator ArmDrugClassical(1) Medicine Name: Ksheerabala taila, Reference: Ashtanga Hrudaya, Route: Otic, Dosage Form: Taila, Dose: 8(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Retention of lukewarm taila in external auditory canal
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients presenting with symptoms of Karnanada irrespective of sex, occupation, religious & social status.
2. Patients in the age group of 18 to 70 years with intact tympanic membrane.
3. Patients with score of 1-18 in Tinnitus Severity Index Questionnaire will be included in the study. 
 
ExclusionCriteria 
Details  1. Objective tinnitus
2. Tinnitus associated with hearing loss, Congenital deformity.
3. Blockage due to stenosis of External auditory canal / wax.
4. Tinnitus due to anemia, diabetes, hypertension, thyroid disorders, glomus tumor etc.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1) Tinnitus Severity Index Questionnaire-based Score  51 days 
 
Secondary Outcome  
Outcome  TimePoints 
Ringing sound in the ear  51 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 
Date of First Enrollment (India)   27/10/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

NEED FOR THE STUDY

Karnanada is one of the karnagata rogas mentioned by Acharya Sushruta. Hearing different types of sounds in the ear in the absence of external stimulus is the main symptom of karnanada. According to Acharya Sushruta, karnasthita vayu becomes vimargagami and takes ashraya in shabdavaha srotas, producing different types of sounds, known as karnanada.

The lakshanas of karnanada can be correlated to the symptoms of Tinnitus. Tinnitus is an auditory sensation within the ears in the absence of any relevant external stimulus to cause it.

15% to 20% of the global population suffers from some form of tinnitus according to CDC. According to a study conducted by Department of Audiology, All India Institute of Speech and Hearing, Mysore, the prevalence of tinnitus was found to be 6.7% among the Indian adult population.

Tinnitus-induced annoyance, tension and insomnia have a significant negative influence on the quality of life and mental health. It can disrupt sleep and cause communication issues, anxiety, irritability, concentration difficulties or depression. In extreme cases, some patients have suicidal thoughts or actions.

There are no effective medicines to treat tinnitus according to conventional systems of medicine. The modes of treatment include prescribing sedatives and tranquilizers, psychotherapy and masking of tinnitus using tinnitus maskers.

According to Acharya Sushruta, Vatahara line of treatment is applicable to treat karnanada-snigdha virechana with vatahara dravyas, nadi sweda, pinda sweda. Karnapoorana is a type of Pravicharana snehana and swedana.

Hence the study has been taken with Karnavatahara taila karnapoorana mentioned in Basavarajeeyam, Ksheerabala taila karnapoorana mentioned in Ashtanga Hrudaya which is safe, devoid of complications, cost effective.

 

HYPOTHESIS:

Null hypothesis

H0- Karnavatahara taila Karnapoorana and Ksheerabala taila Karnapoorana have no significant effect on Karnanada.

 

Alternate hypothesis

H1- Karnavatahara taila Karnapoorana is having better effect than Ksheerabala taila Karnapoorana in Karnanada.

H2- Ksheerabala taila Karnapoorana is having better effect than Karnavatahara taila Karnapoorana in Karnanada.

 
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