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CTRI Number  CTRI/2022/12/048380 [Registered on: 22/12/2022] Trial Registered Prospectively
Last Modified On: 19/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   A clinical trial to study effect of Sesame oil ear oiling and Cerumenolytic ear drops in ear wax. 
Scientific Title of Study   Randomized controlled clinical trial to compare Tila Taila Karnapooran with Cerumenolytic ear drops in Karnaguthak. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gayathri Kamath 
Designation  MS Scholar Shalakya Tantra 
Affiliation  Tilak Ayurved Mahavidyalaya Pune 
Address  Department of Shalakyatantra 3rd floor Tilak Ayurveda Mahavidyalaya 583/2 Rasta Peth Pune Maharashtra

Pune
MAHARASHTRA
411011
India 
Phone  9757021693  
Fax    
Email  gayathrikamath3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sangeeta Salvi 
Designation  HOD Shalakyatantra Department 
Affiliation  Tilak Ayurved Mahavidyalaya Pune 
Address  Department of Shalakyatantra 3rd floor Tilak Ayurveda Mahavidyalaya 583/2 Rasta Peth Pune Maharashtra

Pune
MAHARASHTRA
411011
India 
Phone  9822082795  
Fax    
Email  salvisangeeta@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Gayathri Kamath 
Designation  MS Scholar Shalakya Tantra 
Affiliation  Tilak Ayurveda Mahavidyalaya Pune 
Address  Department of Shalakyatantra 3rd floor Tilak Ayurveda Mahavidyalaya 583/2 Rasta Peth Pune Maharashtra

Pune
MAHARASHTRA
411011
India 
Phone  9757021693  
Fax    
Email  gayathrikamath3@gmail.com  
 
Source of Monetary or Material Support  
Sheth Tarachand Ramnath Charitable Ayurvedic Hospital Pune 
 
Primary Sponsor  
Name  Tilak Ayurved Mahavidyalaya Pune 
Address  Tilak Ayurved Mahavidyalaya Rasta Peth Pune  
Type of Sponsor  Private medical college 
 
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 Gayathri Kamath  seth tarachand ramnath ayurvedic college  department of shalakya tantra ent opd 15 1st floor rasta peth pune 411011
Pune
MAHARASHTRA 		 9757021693

gayathrikamath3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Seth tarachand ramnath ayurvedic college  Approved 
Seth tarachand ramnath ayurvedic college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H612||Impacted cerumen. Ayurveda Condition: KARNA-GUTHAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Cerumenolytic ear dropsCerumenolytic ear drops are used for a period of 7 days. Route of administration is otic and used once a day for a period of 7 days.cerumenolytic ear drops consist of benzocaine, paradichlorobenzene and turpentine oil.
2Intervention ArmProcedure-karNapUraNam, कर्णपूरणम् (Procedure Reference: sushrut chikitsa 24/29, Procedure details: The ayurvedic method of imparting cured oils in the ears is called karnapooran. medicated oil is used to fill the ear canal after snehan and swedan.)
(1) Medicine Name: til taila, Reference: astang sangrah uttar tantra 32-34, Route: Otic, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 4(drops), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with Impacted Wax 
 
ExclusionCriteria 
Details  Patients with uncontrolled Diabetes mellitus, perforated tympanic membrane 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Sample size 70 decrease in aural fullness, aural itching and otalgia.  Sample size 70 decrease in aural fullness, aural itching and otalgia. 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in symptoms like aural itching and otalgia in 3 months  3 months 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   30/12/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The study will be intervened by the treatment of Til Tail Karnapooran  and Ceruminolytic Ear Drops to Group A & Group B respectively. The efficacy of the therapy will be assessed on the basis of subjective criteria for statistical analysis. scoring will be designed according to the severity of symptoms. The subjective gradation of symptoms will be done as follows and the intensity of each symptom will be calculated before treatment, after treatment and after follow up. The effect of treatment results will be Assess in regards to the clinical sign and symptoms on the basis of grading and scoring system. The signs and symptoms will be Assess by adopting the suitable scoring method 
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