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CTRI Number  CTRI/2019/09/021151 [Registered on: 09/09/2019] Trial Registered Prospectively
Last Modified On: 06/09/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic treatment protocol of Poothikarna along with Nirgundyadi thaila karnapoorana in Otomycosis 
Scientific Title of Study   Effectiveness of Classical Ayurvedic Protocol of Poothikarna Along With Nirgundyadi Thaila Karnapoorana in 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 Aswathy Krishna S 
Designation  PG Scholar 
Affiliation  Amrita School of Ayurveda 
Address  Department of Salakyatantra Amrita School of Ayurveda Clappana P O Kollam 690525

Kollam
KERALA
690525
India 
Phone  8129896236  
Fax    
Email  aswathykrishna3891@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K Sivabalaji 
Designation  Assistant Professor 
Affiliation  Amrita School of Ayurveda 
Address  Department of Salakyatantra Amrita School of Ayurveda Clappana P O Kollam 690525

Kollam
KERALA
690525
India 
Phone  7559027947  
Fax    
Email  balajisiva85k@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr K Sivabalaji 
Designation  Assistant Professor 
Affiliation  Amrita School of Ayurveda 
Address  Department of Salakyatantra Amrita School of Ayurveda Clappana P O Kollam 690525

Kollam
KERALA
690525
India 
Phone  7559027947  
Fax    
Email  balajisiva85k@gmail.com  
 
Source of Monetary or Material Support  
Amrita School of Ayurveda Clappana P O Kollam 690525 
 
Primary Sponsor  
Name  Amrita School of Ayurveda 
Address  Amrita School of Ayurveda Clappana P O Kollam 690525 
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 Aswathy Krishna S  Amrita School of Ayurveda  Salakyatantra OPD Department of Salakyatantra Amrita School of Ayurveda Clappana P O Kollam 690525
Kollam
KERALA 
8129896236

aswathykrishna3891@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe Amrita Institute of Medical Sciences Kochi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H603||Other infective otitis externa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Sadyosneha and virechana Ear Mopping karnadhoopanam Pratimarsha nasya Madhupramarjanam Karnapooranam   After virechana with Avipathy churna 20 gm with lukewarm water on first day for next five days ear mopping with aragwadadhikasaya karnadhoopana with gugguluvarthi Madhupramarjana and pratimarshanasya with anutaila 5 drops in each nostril will be done twice daily From 7th day onwards karnapoorana with nirgundyadithaila 2ml on both ears as mentioned in classics will be done for a period of 7 days Internally Aragwadadhi kasaya 50 ml twice daily before food and Aragwadadhi tablet 1 tablet twice daily with kashaya is given during the treatment period 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients of age 18 to 50 years
Satisfying the diagnostic criteria
Either sex
Patients fit for karnapoorana
 
 
ExclusionCriteria 
Details  age not within agelimit of 18 to 50 years
Patient suffering from any systemic diseases and receiving medication
Patient contraindicated for karnapoorana
Other types of ear infection apart from otomycosis
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Fungalmass culture of ear swab
Aural endoscopic pictures 
Fungalmass culture of ear swab will be done before recruitment of patient for the study and after 5 th day of the study
Aural endoscopic pictures after 5th day and 15 the day of study 
 
Secondary Outcome  
Outcome  TimePoints 
VAS scale for pruritis and ear ache Grading of ear blokage  15th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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/ Phase 3 
Date of First Enrollment (India)   10/09/2019 
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="10"
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)?  

Brief Summary  

RATIONALE  Otomycosis also known as fungal otitis externa has typically been described as fungal infection of the external auditory canal. The prevalence of otomycosis has been reported to be as low as 9% in cases of otitis externa and as high as 30.4% in patients presenting with symptoms of otitis or inflammatory conditions of the ear. Moreover it usually occurs most frequently in adults, and less in children. The most common fungal agents causing otomycosis are Aspergillusniger (80% of case) and Candida albicans second common. Several factors have been reported predisposing otomycosis which include; bacterial infections, use of hearing aid or a hearing prosthesis, self inflicted trauma, swimming in contaminated pools, broad spectrum antibiotic therapy, steroids and cytostatic medication, neoplasia and immune disorders .

OBJECTIVE:-The objective of this study is to test the effectiveness of classical ayurvedic treatment protocol of putikarna along with Nirgundyadithailakarnapoorana in otomycosis.

STUDY DESIGN: Pre and post test study of 30 patients who are fulfilling the inclusion criteria will be selected for the present clinical study.

Design of the study

After kayasodhana, for first five days ear mopping with aragwadadhikasaya, karnadhoopana with gugguluvarthi .Madhupramarjana and pratimarshanasya with anutailawill be done twice daily. On 6th day post fungal culture will be done. If the culture report is negative  from 7th day onwards karnapoorana with nirgundyadithaila as mentioned in classics will be done for a period of 7 days.

Aragwadadhikashaya and tablet will be administered internally during the treatment course.

 

Follow-up - After completion of the treatment the patients will be advised to report to Salakya OPD once in a month for a period of three months to assess the sustained effect of treatment.

EXPECTED COST – 30000 to 40000 INR

Statistical analysis will be done using paired t test 

 
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