| CTRI Number |
CTRI/2025/09/095141 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Amraadi Taila in Putikarna with special reference to Otitis Externa |
|
Scientific Title of Study
|
A Randomized Controlled Trial of Amradi Taila Karnapoorana in
Putikarna with special reference to 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 |
Jagzape Pratiksha Ambaji |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved College and Hospital ,Nagpur |
| Address |
Department Of Shalakyatantra OPD No 33,38,37 At Government Ayurved
College and Hospital ,Sakkaradara Square ,Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
7030393138 |
| Fax |
|
| Email |
pratikshajagzape5555@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Vaijwade |
| Designation |
HOD And Professor |
| Affiliation |
Government Ayurved College and Hospital ,Nag |
| Address |
Department of Shalyatantra OPD No 33,37,38 At Government Ayurved
College and Hospital,Sakkaradara Square, Nagpur At Governmemnt
Ayurved College and Hospital ,Sakkaradara Square ,Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9421756462 |
| Fax |
|
| Email |
drapvaijwade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Vaijwade |
| Designation |
HOD And Professor |
| Affiliation |
Government Ayurved College and Hospital ,Nag |
| Address |
Department of Shalyatantra OPD No 33,37,38 At Government Ayurved
College and Hospital,Sakkaradara Square, Nagpur At Governmemnt
Ayurved College and Hospital ,Sakkaradara Square ,Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9421756462 |
| Fax |
|
| Email |
drapvaijwade@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved college Nagpur |
|
|
Primary Sponsor
|
| Name |
Jagzape Pratiksha Ambaji |
| Address |
At Government Ayurved College and Hospital ,Sakkaradara
Square,Nagpur,Maharashtra,India,440024 |
| 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 |
| Dr Pratiksha Jagzape |
Government Ayurved college Nagpur |
Department of Shalakyatantra OPD no 38 of karnarog vibhag Nagpur Maharashtra
Nagpur
MAHARASHTRA |
7030393138
pratikshajagzape5555@gmail.comsée |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H603||Other infective otitis externa. Ayurveda Condition: PUTIKARNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amraadi taila , Reference: Bhavaprakash , Route: Otic, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 10(drops), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 1 Weeks, anupAna/sahapAna: No, Additional Information: -not any | | 2 | Comparator Arm (Non Ayurveda) | | - | Ciprofloxacin ear drop | Ciprofloxacin 0.3% ear drop
Route-Topical
Drops -2 drops BD
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
a) INCLUSION CRITERIA:-
Patients having signs and symptoms of Putikarna(Otitis externa)
Patients having age group 18 to 80 irrespective of sex,
occupation, having Putikarna.
Tympanic membrane should be intact.
Related to external ear only. |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA:-
All patients are excluded which not fulfulling inclusion
criteria.
Patients not willing for treatment.
Patients with any serious debilitating diseases like cancer
tuberculosis.
Perforation of tympanic membrane.
Any disease related to middle ear.
Systemic diseases like DM, HTN etc.
Patients with having hypersensitivity to the
Ciprofloxacin |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary objective:
1. To evaluate the Clinical efficacy of Amradi Taila Karnapoorana in management of Putikarna with special reference to Otitis Externa.
2. To evaluate Clinical efficacy of Ciprofloxacin ear drop in management of Putikarna with special reference to Otitis Externa.
3. To compare effect of Amradi Taila Karnapoorana and Ciprofloxacin 0.3 % ear drop in management of Putikarna with special reference to Otitis Externa. |
0th,3rd,5th,7th day of trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Objective:
1.To review literature & corelate Putikarna in Ayurveda & Otitis Externa in modern science.
2.To study of Karnapoorana in detail . |
0th,3rd,5th,7th day of trial |
|
|
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)
|
05/10/2025 |
| 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)
|
Not Yet Recruiting |
| 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
|
This clinical study evaluates the role of Amradi Taila Karnapoorana in the management of Putikarna which can be correlated with Otitis Externa according to modern science Putikarna is characterized by discharge pain foul smell and discomfort in the ear caused due to trauma infection or secondary involvement of the middle ear Modern management includes ear toileting antibiotics and analgesics while Ayurveda emphasizes local therapies such as Prakshalana Pramarjana Karnapoorana Shirovirechan and Karndhoopan Amradi Taila is prepared from leaves of Amra Jambu Madhuka and Vata which are Kapha Pitta Shamak and possess properties to keep the ear dry reduce discharge control infection relieve pain and remove foul smell This randomized controlled trial aims to access and compare the clinical efficacy of Amradi Taila Karnapoorana with Ciprofloxacin ear drops in the treatment of Putikarna thereby bringing Ayurvedic and modern perspectives for better patient care and sustainable management |