| CTRI Number |
CTRI/2025/01/079573 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
26/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study To See The Effect of panchavalka taila karnapoorana in the Treatment of Karnasrava With Special Referance to Diffuse Otitis Externa. |
|
Scientific Title of Study
|
Randomised Control Clinical Trial of Panchvalkal Taila
Karnapoorana in Karnasrava with special reference to
Diffuse Otitis Externa |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akash Shriram Soni |
| Designation |
Post Graduate Student |
| Affiliation |
Hon. Shri Annasaheb Dange Ayurved Medical College and Post Graduate Reasearch centre , Ashta |
| Address |
Shalakyatantra OPD , Hon. Shri Annasaheb Dange Ayurved Medical College and Post Graduate Reasearch centre , Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
7798655321 |
| Fax |
|
| Email |
akashssoni1581@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Pournima Fasale |
| Designation |
Assistant Professor , Shalakyatantra |
| Affiliation |
Hon. Shri Annasaheb Dange Ayurved Medical College and Reasearch centre , |
| Address |
Shalakyatantra OPD , Hon. Shri Annasaheb Dange Ayurved Medical College and Post Graduate Reasearch centre , Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
9970177583 |
| Fax |
|
| Email |
pournimafasale33@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Pournima Fasale |
| Designation |
Assistant Professor , Shalakyatantra |
| Affiliation |
Hon. Shri Annasaheb Dange Ayurved Medical College and Reasearch centre , |
| Address |
Shalakyatantra OPD , Hon. Shri Annasaheb Dange Ayurved Medical College and Post Graduate Reasearch centre , Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
9970177583 |
| Fax |
|
| Email |
pournimafasale33@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra , Hon. Shri Annasaheb Dange Ayurved Medical College and Reasearch Centre , Ashta ,Maharashtra , 416301 . |
|
|
Primary Sponsor
|
| Name |
Hon Shri Annasaheb Dange Ayurved Medical College and Reasearch Centre |
| Address |
Ashta, Tal. Walwa , 416301 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Akash Shriram Soni |
Dhanwantari Rugnalaya |
Hon. Shri Annasaheb Dange Ayurved Medical College and Reasearch Centre , Ashta , 416301
Sangli
MAHARASHTRA |
7798655321
akashssoni1581@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon. Annasaheb Danger Ayurved Medical College and Post Graduate Research Centre Ashta INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H608||Other otitis externa. Ayurveda Condition: KARNA-SRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Panchvalkal Taila , Reference: Vangasen samhita karnarogadhikar shlok no 86 , Route: Otic, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 7 Days, Reference: No, Route: NA, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Ofloxacin 0.3% Ear drop | Ofloxacin 0.3 % ear drops |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient having classical sign and symptoms of Karnasrava.
2) Patients between 18 to 60 years of age group,
irrespective of gender.
3) Unilateral or bilateral diffuse otitis externa.
4) Intact tympanic membrane. |
|
| ExclusionCriteria |
| Details |
1) Patients having any other karnarogas than karnasrava.
2) Patient having any other ear diseases than Diffuse otitis externa.
3) Patient having systemic disease like DM, HTN , TB , CA ,Leprosy etc. with complications which can lead to interference with the study.
4) Congenital anomalies of the ear.
5) Patient having perforated Tympanic membrane.
6) Patients diagnosed as suppurative otitis media, mastoiditis and cholesteatoma . |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Symptoms like karnaruja (otalgia) , karnasrava ( ear discharge ) , karnakandu ( itching in ear ) , Auricular tenderness will be decreased
and releif from Diffuse otitis externa. |
0th day , 3rd day , 7th day & 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Symptoms like karnaruja (otalgia) , karnasrava ( ear discharge ) , karnakandu ( itching in ear ) , Auricular tenderness will be decreased
and releif from Diffuse otitis externa. |
15th day |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
10/02/2025 |
| 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="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
In modern science practices there is symptomatic treatment for karnasrava (diffuse otitis externa) includes ear toileting followed by medicated wicks, antibiotics and analgesics. Where as in Ayurveda there are many formulations like Karnapoorana, Karnadhoopan, Karnaprakshalan internal medications has been explained. Various drugs for karnasrava have been explored scientifically, Panchvalkal taila karnapoorana was not studied yet. Hence hoping this study contributes further to public health. I have decided to use Panchvalkal taila karnapoorana in management of karnasrava referred from Vangsen Samhita. |