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CTRI Number  CTRI/2023/07/055450 [Registered on: 20/07/2023] Trial Registered Prospectively
Last Modified On: 10/07/2023
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 Sensorineural Hearing Loss 
Scientific Title of Study   A Comparative Study To Evaluate The Efficacy Of Nagaradi Taila Karnapoorana And Ksheerabala Taila Karnapoorana In Badhirya With Special Reference To Sensorineural Hearing Loss. 
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 Swati Raikwar 
Designation  P G Scholar 
Affiliation  Government Ayurveda Medical College, Bangalore 
Address  Department Of Pg Studies In Shalakya Tantra. Shalakya Tantra Opd, Room No.11, Government Ayurveda Medical College,Dhanvantari Road.Banglore

Bangalore
KARNATAKA
560009
India 
Phone  8819966594  
Fax    
Email  swatiraikwar96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rathi S 
Designation  Professor 
Affiliation  Government Ayurveda Medical College Bangalore 
Address  Department of Shalakya Tantra, Government of Ayurveda Medical College,Bangalore

Bangalore
KARNATAKA
560009
India 
Phone  8970779550  
Fax    
Email  drrathi.s@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Swati Raikwar 
Designation  P G Scholar 
Affiliation  Government Ayurveda Medical College, Bangalore 
Address  Department Of Pg Studies In Shalakya Tantra. Shalakya Tantra Opd, Room No.11, Government Ayurveda Medical College,Dhanvantari Road Bangalore

Bangalore
KARNATAKA
560009
India 
Phone  8819966594  
Fax    
Email  swatiraikwar96@gmail.com  
 
Source of Monetary or Material Support  
Dr Swati Raikwar,Government Ayurveda Medical College,Bangalore 
 
Primary Sponsor  
Name  Dr Swati Raikwar 
Address  Ward No -13, Yadav Colony Harrai, Chhindwara ,Madhya Pradesh - 480224 
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 Swati Raikwar  Government Ayurveda Medical College, Bangalore  Department Of Pg Studies In Shalakya Tantra. Shalakya Tantra Opd, Room No.11, Government Ayurveda Medical College,Dhanvantari Road Bangalore
Bangalore
KARNATAKA 		 08819966594

swatiraikwar96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Government Ayurveda Medical College, Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H818||Other disorders of vestibular function. Ayurveda Condition: BADHIRYAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-karNapUraNam, कर्णपूरणम् (Procedure Reference: Sharangdhara Samhita, Procedure details: The ear lobes are gently massaged with oil & usually lukewarm, purified medicated oil is gently poured into boh ears.)
(1) Medicine Name: Nagaradi Taila, Reference: Yoga Ratnakara, Route: Otic, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-karNapUraNam, कर्णपूरणम् (Procedure Reference: Sharangdhar Samhita, Procedure details: The ear lobes are gently massaged with oil & usually lukewarm, purified medicated oil is gently poured into ears.)
(1) Medicine Name: Ksheerabala Taila, Reference: Sahasryayoga, Route: Otic, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients with mild to moderate sensorineural hearing loss.
2. Age groups between 30-70 years will be included in the study.
3. Patients with intact tympanic membrane. 
 
ExclusionCriteria 
Details  1) Congenital sensorineural hearing loss
2) Patients with conducting hearing loss
3) Patients with Tinnitus, Vertigo, Otorrhea
4) Perforated tympanic membrane
5) Patients with other systemic diseases
6) Pregnant and lactating women 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
PURE TONE AUDIOMETRY (PTA)  51 days 
 
Secondary Outcome  
Outcome  TimePoints 
HEARING LOSS  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 3 
Date of First Enrollment (India)   20/07/2023 
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="0"
Months="8"
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   Badhirya Is one among the karnaroga. It is defined as a partial or complete inability to hear. According to acharyas when vitiated vata dosa/kaphanubandha vata dosa obstructing the shabdavaha srotas it results in hearing difficulty called “BADHIRYA ”. Most of the symptoms of badhirya are seen in DEAFNESS, so can be correlated with it.
Deafness is one of the common and most prevalent to all. Over 5% of the population has hearing impairment. Since this becomes increasingly prevalent with age, it is greater then 130 per 1000 population in those aged 65 or over.
The ear normally perceives sounds in the range of 20 to 20,000 vibrations/HZ per second. A person who can’t hear sound at an amplitude of 20dB, is said to be hard of hearing.
Modern science has many ways of intervention in managing deafness, includes medicinal and hearing aids. Medicine like Antiviral, Steroids are given, which give good result but administration of steroids for longer duration can lead to weakening of bones, mental problems. Hearing aids are expensive, users are at high risk for earwax build-up and not providing comfort to patients.
The treatment that are told in classics are Ghrutapana, Snehana, Swedana, karnapurana . Snehana is the principal line of treatment for controlling Vata dosha. Karnapoorana is a type of Bahya snehana, thus it’s the best treatment for Vata nigraha. Hence the study has been taken with Nagaradi taila karnapurana mentioned in YogaRatnakar and Ksheerabala taila karnapurana mentioned in Sahasrayoga which is safe, devoid of complications, cost effective.
 
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