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CTRI Number  CTRI/2025/08/092635 [Registered on: 07/08/2025] Trial Registered Prospectively
Last Modified On: 03/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative pharmaceutico analytical study of deepika tail and devdar siddha tail and its comparative efficacy in the management of karnashoola 
Scientific Title of Study   Comparative pharmaceutico-analytical study of deepika tail and devdar siddha tail and its comparative efficacy in the management of karnashoola 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  JOSTANA JAGDISH SHELKE 
Designation  POST GRADUATE SCHOLAR 
Affiliation  ASHVIN RURAL AYURVED COLLEGE MANCHI HILLSANGAMNER 
Address  ASHVIN RURAL AYURVED COLLEGE AND HOSPITAL.SADHVI PREETISUDHAJI MAHARAJ NAGAR ,MANCHI HILL,ASHVI BK, TAL. SANGAMNER DIST. AHMADNAGAR MAHARASHTRA

Ahmadnagar
MAHARASHTRA
413714
India 
Phone  8888401024  
Fax    
Email  shelkejostana8@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  VD GAURAV DONGARE 
Designation  PROFESSOR 
Affiliation  ASHVIN RURAL AYURVED COLLEGE MANCHI HILLSANGAMNER 
Address  ASHVIN RURAL AYURVED COLLEGE AND HOSPITAL.SADHVI PREETISUDHAJI MAHARAJ NAGAR ,MANCHI HILL,ASHVI BK, TAL. SANGAMNER DIST. AHMADNAGAR MAHARASHTRA

Ahmadnagar
MAHARASHTRA
413714
India 
Phone  9545540997  
Fax    
Email  vdgauravdongare.gd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  JOSTANA JAGDISH SHELKE 
Designation  POST GRADUATE SCHOLAR 
Affiliation  ASHVIN RURAL AYURVED COLLEGE MANCHI HILLSANGAMNER 
Address  ASHVIN RURAL AYURVED COLLEGE AND HOSPITAL.SADHVI PREETISUDHAJI MAHARAJ NAGAR ,MANCHI HILL,ASHVI BK, TAL. SANGAMNER DIST. AHMADNAGAR MAHARASHTRA

Ahmadnagar
MAHARASHTRA
413714
India 
Phone  8888401024  
Fax    
Email  shelkejostana8@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  JOSTANA JAGDISH SHELKE 
Address  ASHVIN RURAL AYURVED COLLEGE AND HOSPITAL.SADHVI PREETISUDHAJI MAHARAJ NAGAR , MANCHI HILL, ASHVI BK, TAL.SANGAMNER DIST. AHMADNAGAR 
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 
JOSTANA SHELKE  ASHVIN RURAL AYURVED COLLEGE   RASSHATRA DEPARTMENT AND ROOM NO 16, ASHVIN RURAL COLLEGE AND HOSPITAL ,SADHVI PREETISUDHAJI MAHARAJ NAGAR MANCHI HILL ASHVI BK TAL. SANGAMNER
Ahmadnagar
MAHARASHTRA 
8888401024

shelkejostana8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ASHVIN RURAL AYURVED COLLEGE ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H920||Otalgia. Ayurveda Condition: KARNASULAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: DEVDARSIDDHA TAIL, Reference: SHARANGDHAR SAMHITA 9/1, Route: Otic, Dosage Form: Taila, Dose: 20(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: EXTERNAL AUDITPORY CANAL SHOULD BE POURED IN THE FPRM OF DROPS TILL EAR CANAL FILLED UP TO THE BASE OF CONCHA.
2Comparator ArmDrugClassical(1) Medicine Name: DEEPIKA TAIL, Reference: SUSHRUT UTTARTANTRA 21/22, Route: Otic, Dosage Form: Taila, Dose: 20(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: EXTERNAL AUDITORY CANAL SHOULD BE POURED IN THE FORM OF DROPS TILL THE EAR CANAL FILLED UP TO THE BASE OF CONCHA.
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Age group is between 20 to 50 years.
2. Irrespective of gender, religion, occupation, socioeconomic status, etc.
3. Patients having signs and symptoms of Karnashoola [Earache].
i. As per described in Ayurveda which same as
Karnashool
ii. Also described by modern science Otalgia at external ear. 
 
ExclusionCriteria 
Details  1. Suppurative otitis media.
2. Perforated ear drum.
3. Pregnant and lactating women.
4. Karnashoola developed due to injury, trauma.
5. Systemic disorders like HTN, DM, Hyperthyroidism, etc.
6. Pratishyay 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
COMPARATIVE PHARMACEUTICO ANALYTICAL STUDY OF DEEPIKA
TAIL AND DEVDAR SIDDHA TAIL AND ITS COMPARATIVE EFFICACY IN THE MANAGEMENT OF KARNASHOOLA 
1 WEEK 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NOT APPLICABLE 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 
Date of First Enrollment (India)   19/08/2025 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
 Ayurveda is ancient science of holistic heading through its herbal remedies. Ayurveda is comprised of eight parts called the Ashtanga of Ayurveda. Shalakya Tantra is branch out for these Ashtanga  .
 Pharmaceutics in Ayurveda is mentioned under the concept of Rasashastra and Bhaishajya Kalpana . Pharmaceutics deals with the any kind of drug used for the medicinal purposes .
 Rasashastra and Bhaiyshajya Kalpana is one of the branch of Ayurveda in which all methods of Ayurvedic medicine purification, preparation, dose and indication is available. Tail kalpanas are the unique preparations which are prepared by using oil as base.
Sense organs are considered important parts of the body. Ayurveda describes these sense organs as Indriya. The ear is called ‘Karnendriya’. Different Acharyas described many preventive measures to keep ear healthy. But even then if diseases occur there are many treatment modalities to cure them.
 One of the Karna Rogas  mentioned in Ayurveda is Karnashoola. The word ’Karnashoola’ is made of two words Karna and Shoola, which means Shoola or pain in Karna Pradesha. It can be taken as a separate disease entity and also can be a lakshana mentioned in Poorvarupa and Rupa avastha of other Karnarogas.
 Acharya Sushruta has mentioned that Karnashoola is developed due to the consumption of Mithya Aahara & Vihara present at the ear region, which causes Vata prakopa which leads to Avarana over Pitta, Kapha Doshas & Rakta results into Vedana, Ruja at ear region. In modern science it can be correlated with the Earache or Otalgia.
 Earache is developed due to the referred pain also. The ear is a very sensitive structure, if there is any painful lesion around the ear, and is supplied by a nerve which also supplies to the ear. Referred pain causes due to the Trigeminal nerve, facial nerve, glossopharyngeal nerve, vagus nerve, second & third cervical nerve lesion.
 Ayurveda has mentioned Ayurveda has mentioned different kinds of Karnapoorana means filling the ear with medicated Tail or other substances.It not only used to cure the disease but a part of healthy living according to  Ayurveda.
 Diseases of ear, nose, and throat are categorized in Urdhavajatrugata Vikara in Ayurveda and  different treatment modalities are described for them.
Here in this study,comparative pharmaceutico analytical study of Deepika Tail and Devdar Siddha Tail and evaluate its efficacy in the in the management of Karnashoola.
Acharya Sushruta mentioned Deepika Tail for the management of Karnashoola. It includes Devdaru and Tila Tail. In this Deepika Tail Karnapoorana is used for Karnashoola treatment. It is Cheap, easily available, known Tail, easy to prepare and use.
In Sharangardhar Samhita Tail preapration given. Devdar siddha tail prapare by accordingly. It is easy to prepare and taking less time also.
 
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