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CTRI Number  CTRI/2025/09/095405 [Registered on: 25/09/2025] Trial Registered Prospectively
Last Modified On: 24/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study Comparing two Ayurvedic oils Dashmool and Bilwadi as ear drops with Sarivadi vati for Hearing Loss 
Scientific Title of Study   Comparative Clinical Evaluation of Dashmool Taila and Bilwadi Taila Karnpooran along with Sarivadi vati orally in Badhirya ( 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  Shriya Uniyal  
Designation  PG Scholar  
Affiliation  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar,Uttarakhand  
Address  Opd-3,Department of Shalakya Tantra Patanjali Ayurved Hospital ,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar,Uttarakhand

Hardwar
UTTARANCHAL
249405
India 
Phone  8171322196  
Fax    
Email  shriyauniyal93@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Dayashankar Singh 
Designation  HOD and Professor 
Affiliation  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar,Uttarakhand 
Address  Opd-3,Department of Shalakya Tantra Patanjali Ayurved Hospital ,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar,Uttarakhand

Hardwar
UTTARANCHAL
249405
India 
Phone  8194028515  
Fax    
Email  dayaayush@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shriya Uniyal  
Designation  PG Scholar  
Affiliation  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar,Uttarakhand 
Address  Opd-3,Department of Shalakya Tantra Patanjali Ayurved Hospital ,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar,Uttarakhand

Hardwar
UTTARANCHAL
249405
India 
Phone  8171322196  
Fax    
Email  shriyauniyal@gmail.com  
 
Source of Monetary or Material Support  
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Yogpeeth Phase 1, Haridwar,Uttarakhand, India 249405 
 
Primary Sponsor  
Name  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 
Address  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Yogpeeth Phase 1, Haridwar,Uttarakhand, India 249405 
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 Shriya Uniyal  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar,Uttarakhand,India, 249405  OPD-3 Patanjali Ayurved hospital, Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan,Haridwar,Uttarakhand,India,249405
Hardwar
UTTARANCHAL 		 8171322196

shriyauniyal93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar  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: BADHIRYAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-karNapUraNam, कर्णपूरणम् (Procedure Reference: Ch Su 5 /84, Procedure details: Purva Karma the patient is positioned lying on the side opposite to the affected ear gentle massage is performed using lukewarm medicated oil around the ear & the side of the neck just below the ear for approximately five minutes Following the massage heat is applied using a towel soaked in hot water This towel is waved touched & gently pressed around the ear for another five minutes to promote relaxation & better absorption Pradhan Karma lukewarm medicated oil is prepared by placing it in a container & warming it through a water bath method To straighten the ear canal the outer part of the ear/pinna is gently pulled backward & upward The oil is then poured drop by drop into the ear canal until it is filled up to the base of the concha The root of the ear is gently massaged to facilitate the absorption of the oil The oil is retained in the ear for approximately three minutes during which the patient performs chewing movements to aid in the process Finally the earlobes are rubbed & gently pulled using fingers dipped in the same medicated oil & the cartilage along with the folds of the ear are carefully massaged to complete the procedure)
(1) Medicine Name: Dashmool Tail, Reference: Chakradatta 57 /29, Route: Otic, Dosage Form: Taila, Dose: 6(drops), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient with mild to severe degree of hearing impairement
2. Patient between the age group of 20 years to 60 years.
3. Patient who are fit for karnpooran.
4. Patient with sensorineural hearing loss. 
 
ExclusionCriteria 
Details  1-Patient with age less than 20 yr and more than 60 yr
2-Patient with profound degree of hearing impairment
3-Patient with perforated tympanic membrane
4-Patient with conductive hearing loss
5-Patient with congenital hearing loss
6-Patient suffering from any systemic disorder like uncontrolled diabetes mellitus,thyroid disorder,kidney disease, uncontrolled hypertension ,cancer etc.
7-Ototoxicity  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Subjective parameters
Tinnitus
Hearing Loss

 		 0,15,30 
 
Secondary Outcome  
Outcome  TimePoints 
Objective parameter
Pure tone audiometry  		 0,15,30 
 
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 
Date of First Enrollment (India)   14/10/2025 
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 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   This study is a Comparative Clinical Evaluation of dashmool Taila and Bilwadi Taila along  with Sarivadi vati  orally in Badhirya  (Sensorineural Hearing Loss)This will be conducted on 60 patients from OPD/IPD of Shalakya - Tantra Department of Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar. Patients will be divided into two groups - 30 pateints will be given Dashmool Taila karnpooran  topically along with Sarivadi vati orally and 30 patients will be given Bilwadi Taila topically along with Sarivadi vati orally. 2 follow up at interval of 15 days after completion of treatment. Assessment will be done on the basis of subjective and objective parameters as discussed earlier. 
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