| 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
|
|
|
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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H920||Otalgia. Ayurveda Condition: KARNASULAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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. | | 2 | Comparator Arm | Drug | Classical | | (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. |