NEED FOR THE STUDY:

In Karnanada, the word Karna refers to the organ for perception of sound , Nada refers to the the rhythmic sound which is produced in the ear¹. In Karnanada the vitiated vayu gets lodged in the shabdavaha srotas thereby causing different types of sounds in the ear ² like bheri, mrudanga, shankha etc³.Treatment includes snehana, swedana (nadi and pinda sweda),snehavirechana⁴ karnapoorana⁵ ,rasayana ,ghritapana.⁶

          Karnanada can be correlated to Tinnitus based on signs and symptoms, Tinnitus is a symptom characterized by the perception of sound in the absence of any external stimulus. There are two types viz subjective (perceived only by the patient ) and objective ( it can be perceived by the observer also)⁷.  Prevelence rate of tinnitus in  India is  6.7%⁸,world wide 4% - 37%.⁹ The management of tinnitus includes reassurance and psychotherapy , technique of relaxation and biofeedback, sedation, transquillizers and tinnitus maskers¹⁰. Though there is no cure for chronic tinnitus there  are various modalities of management, which  significantly improve the quality of patients life.

As mentioned  vata is the  main doshas involved in producing the disease ,treatment is aimed at bringing back normalcy of vata dosha, either by removing the avarana or margavarodha . Viddha karma reduces the localized  vitiated vata dosha  ,that helps in subsiding the disease . Site mentioned for  Viddha karma in karnaroga are karnayor upari samanta(upper post auricular area) and vidhura marmashritatvad adhobhagasya (below vidhura marma). ^11,12  Karnapoorana is benificial in vata roga of karna¹³. Bilwa taila which has vata-kaphagna property¹⁴ is a proven drug used for karnapoorana in management of karnanada.

Hence, viddha karma and bilwataila karnapoorana is taken for study group and only bilwataila karnapoorana is taken as control group.

6.2. REVIEW OF LITERATURE:

1. The detailed study of Karnanada will be done from different classical Ayurveda books.

2.Tinnitus will be referred from modern ENT books.

3. Viddha karma procedure will be referred from Dr.R B Gogate book onViddha and Agni karma chikitsa.

     PREVIOUS WORKS DONE :

1.     Guggari Maheswar S . A Clinical Study On Karna-Nada And Its Management With Apamarga Kshara Taila . Shalakya Tantra . GAMC, Bangalore . 1999

2.      Seetha Lakshmi BS- A Study On Karnapoorana And Its Role In The Management Of Karnanada. A Clinical Study Rajiv Gandhi University Of Health Sciences, Bengaluru. 2005

3.      Apeksha D Rao - A Comparative Study Of Karnpoorana With Nasya karma Using Bala Taila In The Management Of Karnanada. GAMC. Bengaluru. 2010

4.      Hiral Brahmbhatt - Role Of Bilva Taila Karnapoorana With And Without Ashwagandhadya Ghrita In The Management Of Karnanada And Karnakshweda (Tinnitus). Institute For Post Graduate Teaching And Research In Ayurveda, Gujarat Ayurveda University, Jamnagar. 2012

5.      Pankaj Verma - A Clinical Study Of Prativishadi Taila Karnapoorana And Ashwagandhdya GhritaPaana In The Management Of Karnanada W.S.R To  Tinnitus Rajiv Gandhi Govt .Pg Ayuevedic College,Paprola.2013

6.      Bibi Ameena Yallapur - A Comparative Study On Ativishadi Taila Karnapoorana And Panchmulibala Kshira Orally In The Management Of Karnanada.- Govt. Ayurvedic Medical College, Bangalore. 2013

7.     Shifali Sahu-Open Labelled Controlled Clinical Study To Evaluate The Efficacy Of Guduchibala Taila Karnapoorana And Ashwagandhadya Grita In The Management Of Karnaanada (Tinnitus).SJGAMC Koppal. 2020

DRUG REVIEW

KARNA POORANA –BILWA TAILA

INGREDIENTS :

PROCEDURE REVIEW :

VIDDHA KARMA PROCEDURE: 

PURVA KARMA

·       Examination and Investigation .

·       Written informed consent will be taken .

·       Collection of material  : Needle of 26 ½ number, Spirit, Betadin solution, Cotton.

·       Patient will be made to sit comfortably .

·       The point of viddha karma will be cleaned with spirit.

PRADHANA KARMA

·       With the help of needle 26 ½  a gentle prick of 1.5-2.5 mm deep will be made at karnayor upari samanthat and vidhura marmashritatvad adhobhagasya .

 PASCHAT KARMA

·       Pricked sight will be wiped with sterile  cotton .

KARNAPOORANA PROCEDURE :

PURVA KARMA 

·       Examination of patient .

·       Patient  will be made to lie down in right /left lateral position.

·       Gentle massage with oil and mild fomentation around the ear.

PRADHANA KARMA

·       Warm oil (approx-2ml ) poured  in the ear.

·       Gentle massage around the ear  .

·       Oil will be  retained for 100 matra kala (approx-2.5 min )

PASCHAT KARMA

·       After retaining the oil for prescribed time the ear will  be cleaned with dry cotton.

6.3.OBJECTIVES OF THE STUDY:

       1. To evaluate the combined effect of  Viddha karma and Karnapoorana in karnanada .

       2.To compare the efficacy of viddha karma along with karna poorana ,and karnapoorana     in the management of karnanada .

HYPOTHESIS :

1.     H₀ –There is no significant difference in the result between Viddhakarma With Karnapoorana group and  Karnapoorana group in the management of Karnanada.

2.     H₁ –There is a significant difference in the result between Viddhakarma with Karnapoorana group and  Karnapoorana group in the management of Karnanada.

3.     H _1A –Viddha karma with karnapoorana is more effective than only karnapoorana.

4.     H _1B -Karnapoorana is more effective than viddha karma with karnapoorana .

MATERIALS AND METHODS:

7.1. SOURCE OF DATA :

A.    Literary Source :

Ø  Detailed study of Karnanada and its management will be studied from different Ayurvedic classicals(Brihatrayi , laghutrayi and other classical books) 

Ø   Detailed study of Tinnitus will be studied from different modern textbooks (P L Dhingra, Bansal etc)

Ø  Journals and research portals will also be reviewed.

Ø  Viddha and Agnikarma Chikitsa  by R B Gogate  book will be referred .

B.    Sample Source :

Ø  Patients with symptoms of Karnanaada will be enrolled from OPD and IPD of department of Shalakya Tantra, SJGAMC & Hospital, Koppal and other referals through scrutiny and with consent.

C.     Drug Source :

Ø  Raw drug required for bilwa taila will be  procured from standard ayurvedic raw drug supplier and will be authenticated from the department of Dravyaguna S. J . G .A .M .C Koppal

Ø  Bilwa taila will be prepared  under the supervision of Rasashastra and Bhaishajya Kalpana pharmacy department SJGAMC &H Koppal .

Ø  The materials required for viddha karma will be collected from pharmacy.

7.2. METHODS OF COLLECTION OF DATA:

1.     Study Design: Open Labelled Randomised Controlled Clinical Study.

2.     Sample Size : 40 patients fulfilling inclusion criteria.

Allocation: The selected patients will be allocated to study groups based on random allocation using graphpad.

3.     Selection Criteria :

Ø  Diagnostic Criteria:Diagnosis will be made based on classical clinical features of Karnanada (Tinnitus).

A.    INCLUSION CRITERIA:

Ø  Patients  with the  classical clinical features of Karnanada will be selected.

Ø  Patients aged between 18 to 60 years of either gender.

Ø  Patients with intact tympanic membrane .

B.    EXCLUSION CRITERIA:

Ø  Patients  suffering from any Bleeding disorders .

Ø  Patients suffering from any other ear infection .

Ø   Known case of Uncontrolled Diabetes and Hypertension .

Ø  Pregnant and lactating women.

 C.STUDY GROUPS:The interventions are as follows.

  Duration of Study:

·       Treatment duration         - 14 days

·        Follow up                       - 28^th  day

·       Total study duration        - 42 days

C.ASSESSMENT CRITERIA :

Ø  Assessment will be made based on the subjective and objective parameters before, during and after the treatment.

Ø  Clinical findings before and after the treatment shall be observed and recorded in proforma of the case sheet. The result obtained will be statistically analysed and  compared.

PARAMETERS:

·       Subjective Parameters–

T-VAS Scale¹⁹

Tinnitus severity index questionnaire²⁰

·       Objective Parameters

PTA TEST GRADINGS²¹

·       Investigations

   -BT

               -CT

               -RBS

RECORDING AND REPORTING OF ADR:

Any adverse event, observed during the treatment period or during follow up visits will be clearly documented using ADR form and appropriate and timely management will be done. The investing team will report the same to the ethical committee at the earliest.

CONSENT FORM

A consent form will be signed by each patient with their witness. An Informed Consent Form will be maintained for the study.

 STATISTICAL TEST :

All the parameters and observation data will be analysed statistically using WILCOXON RANK, MANN-WHITNEY U TESTS,T TEST .

7.3 Does the study require any investigations or intervention to be conducted on patients or humans or animals? If so, Explain briefly.

ü  Yes

7.4 Has Ethical Clearance been obtained by our Institution?

ü  Yes

8. LIST OF REFERENCES:

1.Dr Sandeep Purohit .World Journal Of Pharmaceutical And Medical Research – A Case Study Of Karnanada Wst To Tinnitus . Published On 02 /12 /2019.

2.Atrideva Gupta, Astanga Hridaya Of Vagbhata With Vidhyotini Hindi Commentary ,Uttarasthana Chapter 17/9 , Reprint Edition ,2022 ,VaranasiChaukhamba Prakashan ,Pg no -692.

3.Prof Yadunandana Upadhyaya ,Madhava Nidana Of Madhavakara With Madhukosha Commentary By Shri Vijayaraksita And Shrikantadatta With Hindi Vidhotini Commentary , Chapter 57/2-3 , Reprint Edition 2013 ,Chaukhamba Prakashan ,Pg no-286

4.Maharshina Sushrutena Vicharita  .Susthrutha Samhita ,Shri Dalhana Acharya Vicharita Nibandha Sangraha Vyakya uttaratantra  21/5,Edition 2014,Chaukhamba sankrith samsthan Varanasi ,Pg no-645.

5.Atrideva Gupta, Astanga Hridaya Of Vagbhata With Vidhyotini Hindi Commentary ,Uttarasthana Chapter 18/839 , Reprint Edition ,2022 ,VaranasiChaukhamba Prakashan ,Pg no-692.

6.Maharshina Sushrutena Vicharita  .Susthrutha Samhita ,Shri Dalhana Acharya Vicharita Nibandha Sangraha Vyakya uttaratantra 21/3,Edition 2014,Chaukhamba sankrith samsthan Varanasi ,Pg no -645.

7.Mohan Bansale Disease Of Ear ,Nose And Throat With Head And Neck Surgery .Second Edition 2012 ,jaypee brothers medical publishers ,Pg no-139.

8.Sajana Arya ,Yoshita Sharma ,Prashanth Prabhu.Prevelence Of Tinnitus And Its Characteristics Among Indian Adult Population.Published On 2023-05-25.

9.Berit Hackenberg,Karolin O Brien , Julia Doge , Karl J Lackner , Manfred E Beutel , Thomas Munzel Norbert Pfeiffer, Andreas Schulz, Irene Schmidtmann Philipp S Wild ,Christoph Matthias And Katharina Bahr –Hamm.-Tinnitus Prevalence In The Adult Population – Result From The Gutenberg Health Study .2023.

10.P L Dingra And Shruthi Dingra ,Diseases Of Ear Nose And Throat And Head And Neck Surgery, 6^th Edition 2014,published by elsivier a division of reed Elsevier india private limited ,Pg No -130.

11.Dalhana Acharya Vicharita Nibandha Sangraha Vyakya,Sushrutha  Samhita Sharira Sthana 8/17 ,edition  2014,Chaukhamba sankrith samsthan Varanasi  ,Pg no -381.

12.Dr.R B Gogate ,Viddha And Agni Karma Chikitsa , Sixth Edition ,Published by Vaidhya Gogate Memorial Foundation 102 Ramprasad chamber 368/1 nanapeth Pune ,Sixth Edition December 2023.Pg  no -35.

13.Pt .Kashinathshashtri And Dr Gorakha Nath Cahturvedi , Charaka Samhita With Vidhyotini Hindi Commentary ,Sutrasthana Chapter 5/84 ,Reprint Edition 2009 Varanasi , Published By Chaukhambha Bharathi Academy .Pg no-128.

14.Govinda Dasji Bhisagratna .Bhaishajya Ratnavaali Commented By Vaidhya Shri Ambika Data Shastri English Translation By Dr Kanjiv Lochana, Karna Roga Chikitsa Prakarana  62/29,Edition 2014,chaukhambha Sanskrit sansthan varanaasi ,Pg no-236.

15.Dr. J L N Shastri .Dravya Guna Vijnana , Study Of Essential Medicinal Plants Of Ayurveda ,Foreward By Prof K.C Chunekar ,Reprint Edition 2016, Pubhilshed By Chaukhambha Orientalia Varanasi,Pg . No -110.

16.Acharya Vidhyaadhara Shukla ,Prof Ravidatta Tripathi . Charaka Samhita Sutra Sthan 1/100, ,Reprint -2013, Pubhished By Chaukhaambha Sansrith Pratisthan,Pg No -45.

17.Acharya Vidhyaadhara Shukla ,Prof Ravidatta Tripathi , Charaka Samhita  Sutra Sthana 27/222,Reprint -2013, Pubhished By Chaukhaambha Sansrith Pratisthan,Pg No -411.

18.Government Of India Department Of Indian System Of Medicine And Homeopathy. The Ayurvedic Pharmacopoeia Of INDIA ,Part 1Volume 3,First Edition .The Controller Of Publications Civil Lines ,Delhi 110054.Pg No-194.

19.Soo Ji Sirh ,So Woon Sirh ,Han Yong Mun,Heon Man Sirh .Integrative Treatment For Tinnitus Combining Repeated Facial And Auriculotemporal Nerve Blocks With Stimulation Of Auditory And Non Auditory Nerves .Front .Neurosci,28 February 2022, Sec . Auditory Cognitive Neuroscience .Volume 16 -2022 | https:// doi .org /10.3389/fnins .20122.758575

20.Robert L Folmer ,Phd ,William Hal Martin ,Phd And Yongbing Shi,Md,Phd. Tinnitus Questions To Reveal The Cause ,Answer To Provide Relief . July 2004 .

21.World Health Organisation Grades Of Hearing Impairement.( WHO ,2008 ).