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CTRI Number  CTRI/2023/07/054713 [Registered on: 04/07/2023] Trial Registered Prospectively
Last Modified On: 03/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of Ghritpana and Karnapooran with and without Gudanagar toya (Shodhan) Nasya in the Management of Karnanaad 
Scientific Title of Study   A Comparative Clinical Study Of Ghritpana And Karnapooran With And Without Guda Nagar Toya Nasya In The Management Of Karnapranad 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Milina Rajendra Mehta 
Designation  PG Scholar Shalakyatantra 
Affiliation  Government Akhandanand Ayurveda College Bhadra Ahmedabad 
Address  OPD NO 3 Shalakya Tantra Department Government Akhandanand Ayurveda College Bhadra Ahmedabad Gujarat India 380001

Ahmadabad
GUJARAT
380001
India 
Phone  9033677874  
Fax    
Email  mehtamr20@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Vd Hemangi B Shukla 
Designation  H.O.D. 
Affiliation  Government Akhandanand Ayurveda College Bhadra Ahmedabad 
Address  OPD NO 3 Shalakya Tantra Department Government Akhandanand Ayurveda College Bhadra Ahmedabad Gujarat India 380001

Ahmadabad
GUJARAT
380001
India 
Phone  9825504280  
Fax    
Email  drhemangishukla@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Vd Hemangi B Shukla 
Designation  H.O.D. 
Affiliation  Government Akhandanand Ayurveda College Bhadra Ahmedabad 
Address  OPD NO 3 Shalakya Tantra Department Government Akhandanand Ayurveda College Bhadra Ahmedabad Gujarat India 380001


GUJARAT
380001
India 
Phone  9825504280  
Fax    
Email  drhemangishukla@gmail.com  
 
Source of Monetary or Material Support  
OPD NO. 3 Department Of Shalakya Tantra Government Akhandanand Ayurveda College Bhadra Ahmedabad 
 
Primary Sponsor  
Name  Government Akhandanand Ayurveda College 
Address  OPD NO 3 Shalakya Tantra Department Government Akhandanand Ayurveda College Bhadra Ahmedabad Gujarat India  
Type of Sponsor  Government 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 
MILINA RAJENDRA MEHTA  Government Akhandanand Ayurveda College  OPD NO 3 Shalakya Tantra Department Government Akhandanand Ayurveda College Bhadra Ahmedabad Gujarat India
Ahmadabad
GUJARAT 		 9033677874

mehtamr20@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Government Akhandanand Ayurved College Ahmedabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H931||Tinnitus. Ayurveda Condition: KARNA-NADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-avapIDanam, अवपीडनम् (Procedure Reference: Chakradatta, Procedure details: Gudanagar toya Nasya as Shodhan nasya )
(1) Medicine Name: Gudanagar toya, Reference: Chakradatta, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 6(drops), Frequency: od, Duration: 3 Days
2Comparator ArmProcedure-karNapUraNam, कर्णपूरणम् (Procedure Reference: Chakradatta, Procedure details: Karnapooran for 21 days along with ghritapan for 21 days)
(1) Medicine Name: Bilwa taila, Reference: Chakradatta, Route: Otic, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 21 Days
(2) Medicine Name: Goghrita, Reference: Sushruta samhita, Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: od, Duration: 21 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Signs and symptoms of Karnapranad given in Ayurvedic texts
2.Normal External auditory canal
3.Intact Tympanic membrane
4.Shodhan Nasya yogya
5.Snehpana yogya 
 
ExclusionCriteria 
Details  1.Age below 18 and above 60 years
2.Sign and symptoms of Karnakshwed
That is, Hearing of Venughoshvat sound in ear
3.Wax in External auditory canal
4.Perforated Tympanic membrane
5.Shodhan Nasya Ayogya
6.Snehpana Ayogya
7.Patients suffering from any chronic debilitating diseases like Diabetes mellitus, Hypertension, etc. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To reduce intensity of sound heard in ear  34 days 
 
Secondary Outcome  
Outcome  TimePoints 
To improve quality of life   34 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   17/07/2023 
Date of Study Completion (India) 26/07/2024 
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)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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   Today due to unhealthy food habits, less exercise etc. factors are responsible for provocation of Avrutavayu. 
Besides this, noise pollution, excessive use of earphones, habits of shower bath, use of Air conditioner etc. factors are helping in the development of samprapti of Karnapranad.
National and Global data of Karnapranad are not available but in this era of stress, noise pollution, the number of patients of Karnapranad are increased.
The quality of life of the patient with Karnapranad is detoriate day by day. 
Ayurveda is a fundamental science. It provides systematic and local protocol to cure the diseases as well as better quality of life. 
There may be effective results found after specific line of treatment in Karnapranad but it requires thorough and intensive research. 
In Karnapranad there is vimarga gaman of avruta vayu. 
To treat the avruta vayu first we have to treat the Avarana. 
So, Shodhan nasya has been selected along with conventional treatment of Ghritpana and Karnapooran for the study.
 
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