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CTRI Number  CTRI/2023/05/052945 [Registered on: 19/05/2023] Trial Registered Prospectively
Last Modified On: 18/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Managment of Tinnitus through Ayurveda 
Scientific Title of Study   A Randomized Comparative Clinical study to evaluate the effect of Nirgundyadi Tail karnapoorna and Hingvadi Tail karnapoorna along with Ashwagandha Ghrita Orally in Karnanada(Tinnitus) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashu 
Designation  Professor 
Affiliation  Shri Krishna Government Ayurvedic College and Hospital 
Address  Room No 108 Department of Shalakya Tantra Shri Krishna Government Ayurvedic College and Hospital

Kurukshetra
HARYANA
136118
India 
Phone  9416553131  
Fax    
Email  drashukataria@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashu 
Designation  Professor 
Affiliation  Shri Krishna Government Ayurvedic College and Hospital 
Address  Room No 108 Department of Shalakya Tantra Shri Krishna Government Ayurvedic College and Hospital


HARYANA
136118
India 
Phone  9416553131  
Fax    
Email  drashukataria@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashu 
Designation  Professor 
Affiliation  Shri Krishna Government Ayurvedic College and Hospital 
Address  Room No 108 Department of Shalakya Tantra Shri Krishna Government Ayurvedic College and Hospital


HARYANA
136118
India 
Phone  9416553131  
Fax    
Email  drashukataria@gmail.com  
 
Source of Monetary or Material Support  
Department of shalakya tantra, Shri Krishna Ayush University, Sec 8, Umri road Kurukshetra, 136118 
 
Primary Sponsor  
Name  Dr Akshay Garg 
Address  Shri Krishna Government Ayurvedic C0llege and Hospital Kurukshetra 
Type of Sponsor  Other [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 Akshay Garg  Shri Krishna Government Ayurvedic College and Hospital,Kurukshetra  OPD No.54, Shalakya tantra, Shri Krishna Ayush University Sector 8 Umri Road Kurukshetra Haryana 136118
Kurukshetra
HARYANA 
7206819940

drakshaygarg1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  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-karNapUraNam, कर्णपूरणम् (Procedure Reference: Yogaratnakar, Procedure details: Patient is Advised to lie down on a a table in right or left lateral position. The area around the ear is massaged with luke warm oil for 5 minutes till the oil gets absorbed. Give hot fomentation with hot water bag untill the area becomes little erythematous then lukewarm Hingvadi Taila is poured into the patient ear canal upto filling of external auditory canal in each ear(2-2.5ml) for 100 Matrakala (Approx 2.5-3Minutes) once a day in evening(sayankala) 3 sittings of 8 days with 3 days gap bet)
(1) Medicine Name: Hingvadi Taila, Reference: Gada Nigrah, Route: Otic, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 30 Days
(2) Medicine Name: Ashwagandha Ghrita, Reference: Chakartdatta, Route: Oral, Dosage Form: Ghrita, Dose: 10(g), Frequency: bd, Duration: 30 Days
2Comparator ArmProcedure-karNapUraNam, कर्णपूरणम् (Procedure Reference: Yogaratnakar, Procedure details: Patient is Advised to lie down on a a table in right or left lateral position. The area around the ear is massaged with luke warm oil for 5 minutes till the oil gets absorbed. Give hot fomentation with hot water bag untill the area becomes little erythematous then lukewarm Nirgundyadi Taila is poured into the patient ear canal upto filling of external auditory canal in each ear(2-2.5ml) for 100 Matrakala (Approx 2.5-3Minutes) once a day in evening(sayankala) 3 sittings of 8 days with 3 days gap )
(1) Medicine Name: Nirgundyadi Taila, Reference: Yogaratnakar, Route: Otic, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 30 Days
(2) Medicine Name: Ashwagandha Ghrita, Reference: Chakardatta, Route: Oral, Dosage Form: Ghrita, Dose: 10(g), Frequency: bd, Duration: 30 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients between age of 16-60 years irrespective of age, sex, caste, religion etc.
2.Patients will selected on the basis of signs and symptoms of Karnanada (Tinnitus).
3.Subjective type of tinnitus.
4.Patients willing to be registered for trial 
 
ExclusionCriteria 
Details  1.Patients of age <16 years and >60 years
2.Patients suffering from any chronic debilitating disease like DM, HTN, KOCH’S and with other ear pathologies.
3.Objective type of Tinnitus.
4.Cases of tinnitus which required surgical intervention.
5.CSOM,Otomycosis,Perforated TM.
6.Pregnant, Immune compromised patients
7.Tinnitus associated with disease like – any growth of middle ear, Aneurysms of carotid artery, palatal myoclonus, and meningitis.
8.Degree of hearing loss greater than 40 dB.
9.Paitents not willing to be registered for trial. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in subjective and objective criteria of Karnanada  90 Days 
 
Secondary Outcome  
Outcome  TimePoints 
1)To study the Karananada from various ayurvedic texts.
2)To study the Tinnitus from modern texts.
3)To study the Karanapoorna from various ayurvedic texts.
4)Correlation of Karnanada with Tinnitus. 
30 Days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/07/2023 
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="0"
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  
Tinnitus is a common problem for millions of people, as epidemiological studies have reported its prevalence to be between 8 to 25.3% of the population of the United States.Similarly, population based studies conducted in other nations have found a similar prevalence of Tinnitus, ranging from 4.6% to 30%.Tinnitus is a common and debilitating disorder in India with a prevalence of more than 7% of the Indian population.It severely affects the quality of life of around 1-3% of the world.Tinnitus affects 10 to 15 % of adult general population. About 20 % of Tinnitus population requires serious clinical .The 7th – 13th of February 2022 brings us Tinnitus Awareness Week Recognized each year throughout the world in the first full week of February, the purpose of this week is to educate the public about the symptoms of tinnitus and how it affects people.The prevalence of tinnitus increases to 70-85% in the hearing-impaired population. 

                                        Available treatments for the management of Tinnitus are diverse. Highest evidence for clinical efficacy is available for cognitive-Behavioral therapies. Further established treatment includes counselling and various forms of sound therapy along with methods that attempt to increase input to the auditory system, such as hearing aids and masking of Tinnitus, Sedation and Tranquilizers.Despite its prevalence and effect on quality of life there is no evidence based guideline about management of Tinnitus till today and hence poses a challenge for finding such drugs or therapies in alternate systems of medicine.Ayurveda has a systematic line of treatment in the management of Karnanada. The Line of treatment in Ayurveda for four diseases viz. Karnashoola, Pranada, Karnashweda and Badhirya is similar. The General line of Treatment for Karnarogas is Ghritapana , Rasayana, Avyayama, Ashirasnana, Brahmacharya, AkathanaKarna is one of the Adhisthana of Vata Dosha..In Ayurveda since vata is the main dosha involved in karnanada disease. The treatment should be aimed at Vatashamana and Rasayana Karnapooran is an important therapy in karnarogas.It has unique quality of getting absorbed easily by the pores in the skin and there by act to supply the nutrition to nerves.Hence in present study, Karanpoorna with Nirgundyadi Tail and Hingvadi Tail possessing vatahara property is selected for the study. Ghrita is having“Sanskarasya  Anuvartanatva so Ashwagandha Ghrita is selected for internal administration having Rasayana,Balya and Vatahara properties which can prevent age related degenerative changes in the inner ear.Hence it is proposed to undertake this study entitled "A Randomized Comparative Clinical Study to Evaluate the Effect of Nirgundyadi Tail Karnapoorna and Hingvadi Tail Karnapoorna along with Ashwagandha Ghrita Orally in Karnanada(Tinnitus)"
 
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