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CTRI Number  CTRI/2022/09/045405 [Registered on: 12/09/2022] Trial Registered Prospectively
Last Modified On: 08/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Vidanga arka in fungal infection of ear 
Scientific Title of Study   "A Randomized open labelled controlled clinical study to evaluate the efficacy of VIDANGA ARKA in the management of KARNASHOOLA with special reference to otomycosis" 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Savitri B Saunshimath 
Designation  PG Scholar  
Affiliation  Sri Sri College of Ayurvedic Science and Research  
Address  Room number 305 Department of PG Studies in Shalakyatantra Sri Sri College of Ayurvedic Science and Research Hospital 21st KM Kanakapura main road Udayapura post Bengaluru 560082 Bangalore KARNATAKA

Bangalore
KARNATAKA
560082
India 
Phone  7204460302  
Fax    
Email  savitrisaunshimath9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Naveen B S 
Designation  Professor and HOD  
Affiliation  Sri Sri College of Ayurvedic Science and Research  
Address  room number 305 department of PG studies in Shalakyatantra Sri Sri College of Ayurvedic Science and Research 21st KM, Kanakapura Road, Udayapura Post Banglore-560082

Bangalore
KARNATAKA
560082
India 
Phone  9844991405  
Fax    
Email  navs009@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Naveen B S 
Designation  Professor and HOD  
Affiliation  Sri Sri College of Ayurvedic Science and Research  
Address  room number 305 department of PG studies in Shalakyatantra Sri Sri College of Ayurvedic Science and Research 21st KM, Kanakapura Road, Udayapura Post Banglore-560082

Bangalore
KARNATAKA
560082
India 
Phone  9844991405  
Fax    
Email  navs009@gmail.com  
 
Source of Monetary or Material Support  
sri sri college of ayurvedic science and research hospital  
 
Primary Sponsor  
Name  Dr Savitri B Saunshimath 
Address  Sri Sri College of Ayurvedic Science and Research 21st KM, Kanakapura Road, Udayapura Post Banglore-560082 
Type of Sponsor  Other [others (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 SAVITRI B SAUNSHIMATH  SRI SRI COLLEGE OF AYURVEDA SCIENCE AND RESEARCH HOSPITAL  Room number 305 Department of PG Studies in Shalakyatantra Sri Sri College of Ayurvedic Science and Research Hospital 21st KM Kanakapura main road Udayapura post Bengaluru 560082
Bangalore
KARNATAKA 
07204460302

savitrisaunshimath9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Sri Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H618||Other specified disorders of external ear. Ayurveda Condition: KARNASULAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: madhu , Reference: sushruta samhita, Route: Topical, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 1(drops), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -ear mopping before treatment
2Intervention ArmDrugClassical(1) Medicine Name: vidanga arka, Reference: arka prakasha, Route: Topical, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 1(drops), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -ear mopping before treatment
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Subjects fulfilling the diagnostic criteria.
2. Subjects within the age of 21 to 60 years irrespective of gender, occupation, religion, socio- economic status and duration of illness.
3. Subjects willing to sign the informed consent.
 
 
ExclusionCriteria 
Details  1. Subjects having perforated tympanic membrane.
2. Subjects with other aural pathologies (external, middle and inner ear pathologies)
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
changes in the following symptoms will be documented
1. karnashoola
2. karnakandu
3. karnasrava
4. karnapratinaha
 
1.0th day - Before treatment
2.7th day - After treatment
3.14th day - Follow up 1
4.21st day - Follow up 2
5.28th day – Follow up 3
 
 
Secondary Outcome  
Outcome  TimePoints 
fungal mass will be assessed using aural endoscopy  1.0th day - Before treatment
2.7th day - After treatment
3.14th day - Follow up 1
4.21st day - Follow up 2
5.28th day – Follow up 3
 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/09/2022 
Date of Study Completion (India) 20/06/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

    In this comparative clinical study, Vidanga Arka is taken as the trial drug and Madhu is taken as the control drug. Arka preparations are not only potent, they are also sterile, and have a longer shelf life. The mode of administration of drugs as ear drops is simple and cost effective in the management of Otomycosis. Therefore, in this present study, an effort has been made to evaluate and compare the efficacies of Vidanga Arka and Madhu in the management of Karnashoola w.s.r. to Otomycosis.

 
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