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CTRI Number  CTRI/2022/01/039788 [Registered on: 28/01/2022] Trial Registered Prospectively
Last Modified On: 27/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Use of Yav-agarudi Karnadhoopan in Putikarna.  
Scientific Title of Study   Randomized Controlled Trial of Yav-agarudi Karnadhupan in Putikarna With Special Reference to Otitis externa.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shubhangi Dattatray Bharankar 
Designation  PG scholar 
Affiliation  Resident doctor 
Address  Government Ayurvedic College Nagpur Raje raghuji nagar Sakkardhara square in front of kamala neharu college
Government Ayurvedic College Nagpur Raje raghuji nagar sakkardhara square in front of kamala neharu college
Nagpur
MAHARASHTRA
440024
India 
Phone  09730663072  
Fax    
Email  shubhabharankar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  V G Dhakate 
Designation  Associate Professor 
Affiliation  Associate professor 
Address  Government Ayurvedic College Nagpur Raje raghuji nagar Sakkardhara square
Government Ayurvedic College Nagpur Raje raghuji nagar sakkardhara square nagpur
Nagpur
MAHARASHTRA
440024
India 
Phone  9860517302  
Fax    
Email  drvijaydhakate6@gmail.com  
 
Details of Contact Person
Public Query  
Name  V G Dhakate 
Designation  Associate Professor 
Affiliation  Associate professor 
Address  Government Ayurvedic College Nagpur Raje raghuji nagar sakkardhara square
Government Ayurvedic College Nagpur Raje raghuji nagar sakkardhara square
Nagpur
MAHARASHTRA
440024
India 
Phone  9860517302  
Fax    
Email  drvijaydhakate6@gmail.com  
 
Source of Monetary or Material Support  
Government ayurved college and hospital nagpur  
 
Primary Sponsor  
Name  Self Shubhangi Bharankar 
Address  Government Ayurvedic College and Hospital Nagpur 
Type of Sponsor  Other [Self shubhangi bharankar] 
 
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 
Shubhangi Bharankar  Government Ayurvedic College and Hospital raje raghuji nagar nagpur  Shalakyatantra department Government Ayurvedic College Nagpur Raje raghuji nagar
Nagpur
MAHARASHTRA 		 09730663072

shubhabharankar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H609||Unspecified otitis externa. Ayurveda Condition: PUTIKARNAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-karNadhUpanam, कर्णधूपनम् (Procedure Reference: Ashtang sangrah uttartantra 22/42-43, Procedure details: Dhoopana yantra is funnel shaped and its one end will keep the ear covered for the passage of Dhooma into the ear canal and other end where Yav-agaruwadi Dhoopana varti will be placed which produces fumes. This Dhoopana will be given for 5 min. )
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having signs and symptoms of Putikarna by Ayurvedic as well as modern science
Patients having age group 15 years to 60 years irrespective of sex ocuupation having Putikarna
Tympanic membrane intact
Related to external ear only 
 
ExclusionCriteria 
Details  All patients are excluded which not fulfulling inclusion criteria
Patients not willing for treatment
Patients with any serious debilitating disease like cancer tuberculosis
Perforation of tympanic membrane
Any disease related to middle ear
Systemic diseases like DM HTN etc 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study whether the Yavagarudi Karnadhupan with antibiotic is more effective than only antibiotic in Putikarna Or not with special reference to Otitis externa  18 month 
 
Secondary Outcome  
Outcome  TimePoints 
To review literature of Putikarna in Ayurveda and Otitis externa in modern science
To do detailed study of Karnadhupan 		 18 month 
 
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 2 
Date of First Enrollment (India)   30/01/2022 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The study is randomized controlled trial of Yav-agarudi  Karnadhupan in Putikarna  with special reference to Otitis externa This is conducted as a compulsory part of pg course at single centre  
The primary outcome is to study whether the Yav-agarudi Karnadhupan with antibiotic is more effective than only antibiotic in Putikarna or not and the secondary outcome is to review literature of Putikarna in ayurveda and Otitis externa in modern science 
To do detailed study of Karnadhupan
 
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