FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/071384 [Registered on: 26/07/2024] Trial Registered Prospectively
Last Modified On: 24/07/2024
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   Ayurvedic Management of Karna Kandu- Otomycosis 
Scientific Title of Study   A Randomized Comparative Clinical Study to Evaluate the Effect of Madhu with Rasanjana Karna Poorana and Clotrimazole 1 Percent Ear Drops in the Treatment of Karnakandu - Otomycosis  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gurjeet Singh 
Designation  PG Scholar 
Affiliation  Institute For Ayurved Studies and Research Faculty of Ayurved, SKAU Kurukshetra  
Address  OPD No. 50 Shalakya KNMS Institute for Ayurved Studies and Research Hospital, Sector 8 Umri road Kurukshetra 136118

Kurukshetra
HARYANA
136118
India 
Phone  7404666106  
Fax    
Email  guzzu17@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashu 
Designation  Professor and Chairperson 
Affiliation  Institute For Ayurved Studies and Research Faculty of Ayurved, SKAU Kurukshetra  
Address  Room no. 108 PG Dept of Shalakya Tantra Institute for Ayurved Studies and Research, SKAU Sector 8 Umri road Kurukshetra 136118

Kurukshetra
HARYANA
136118
India 
Phone  9416553131  
Fax    
Email  drashukataria@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gurjeet Singh 
Designation  PG Scholar 
Affiliation  Institute For Ayurved Studies and Research Faculty of Ayurved, SKAU Kurukshetra  
Address  OPD No. 50 Shalakya KNMS Institute for Ayurved Studies and Research Hospital, Sector 8 Umri road Kurukshetra 136118

Kurukshetra
HARYANA
136118
India 
Phone  7404666106  
Fax    
Email  guzzu17@gmail.com  
 
Source of Monetary or Material Support  
Institute for Ayurved Studies and Research Kurukshetra 
 
Primary Sponsor  
Name  Institute for Ayurved Studies and Research  
Address  Sector 8 Umri Road Kurukshetra Haryana 136118 
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 Gurjeet Singh  Institute for Ayurved Studies and Research Hospital  OPD No. 50 Shalakya KNMS, Institute for Ayurved Studies and Research Hospital, sector 8 Umri road Kurukshetra 136118
Kurukshetra
HARYANA 		 7404666106

guzzu17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shri Krishna Ayush University Kurukshetra   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H624||Otitis externa in other diseases classified elsewhere. Ayurveda Condition: KARNA-KANDU,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Clotrimazole 1% Ear Drops3 drops bd in each ear for 15 days
2Intervention ArmProcedure-karNapUraNam, कर्णपूरणम् (Procedure Reference: Sharangdhara Samhita, Procedure details: Duration: 15 days Dose: 3 drops Time: BD Method of application: Instillation of ear drops in the EAC )
(1) Medicine Name: Madhu mixed with 10 % Rasanjana, Reference: Anubhuta yoga, Route: Otic, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 3(drops), Frequency: bd, Duration: 15 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients having signs and symptoms of karnakandu.
2) Patients having signs and symptoms Otomycosis.
3) Patients between 16 to 60 years of age group.
4) Irrespective of Gender, Caste, Religion, Economical Class, Race.
5) Unilateral or bilateral Otomycosis.
6) Intact tympanic membrane. 
 
ExclusionCriteria 
Details  1) Age: - below 16 years and above 60 years.
2) CSOM.
3) ASOM.
4) Conductive deafness.
5) Sensorineural Hearing Loss.
6) Mixed hearing loss.
7) Inner ear pathology like acoustic neuroma, Meniere’s disease.
8) Malignancy.
9) Pregnant women.
10) Head injury or injury to ear.
11) History of intake of ototoxic drugs.
12) Patient who needs surgical intervention.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Changes in Otoscopic Findings.

2.Changes in Smear Examination Findings.

 		 16th day

 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in sign & symptoms of Karnakandu -Otomycosis as under:- 1) Intense Itching.
2) Discomfort or pain in the ear.
3) Watery discharge with Musty odour.
4) Ear Blockage 		 45th day 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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   N/A 
Date of First Enrollment (India)   05/08/2024 
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 Yet Recruiting 
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   Otomycosis is commonly seen in tropical and subtropical regions of the world. The frequency to otomycosis depends upon different climatic conditions with higher prevalence in the hot, humid and dusty areas. Review of the literature reveals otomycosis to be a common medical problem in India. Prevalence rate of Otomycosis in India is about 9%. Honey is the natural food product. It contains number of amino acids, so it has acidic pH. it lyses the fungus and bacteria as it has high osmolarity. Its antifungal, antibacterial action is proved by previous in vitro study. With this background present study is planned to know the effect of Honey in the management of Otomycosis. Rasanjana exhibits antibacterial and antifungal properties and is mentioned under kandughana mahakashaya. In present study, Karnapoorna by Madhu with Rasanjana and Clotrimazole 1% Ear Drops is considered as Topical therapy. So, Karnapoorna by Madhu with Rasanjana have been selected as treatment modalities in the study.   
Close