| CTRI Number |
CTRI/2025/06/088498 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
09/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study of structural involvements and changes in ears in patients of Putikarna |
|
Scientific Title of Study
|
A cross-sectional study to find structural involvements and changes in ears in
patients of “Putikarna” using High-Resolution Computed Tomography (HRCT)
of Temporal Bone. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaishnavi Sanjayrao Dhole |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre, Nigdi Pune |
| Address |
PDEAs College of Ayurved and Research Centre Rachana Sharir Department,Ground floor,Room no.1,Sector 25,Nigdi,Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8999520532 |
| Fax |
|
| Email |
vaishnavi.dhole23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhuri Mahadar |
| Designation |
Associate Professor |
| Affiliation |
PDEAS College of Ayurved and Research Centre, Nigdi Pune |
| Address |
PDEAs College of Ayurved and Research Centre Rachana Sharir Department,Ground floor,Room no.1,Sector 25,Nigdi,Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9822002667 |
| Fax |
|
| Email |
drmadhuri75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhuri Mahadar |
| Designation |
Associate Professor |
| Affiliation |
PDEAS College of Ayurved and Research Centre, Nigdi Pune |
| Address |
PDEAs College of Ayurved and Research Centre Rachana Sharir Department,Ground floor,Room no.1,Sector 25,Nigdi,Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9822002667 |
| Fax |
|
| Email |
drmadhuri75@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAS College of Ayurved and Research Centre, Nigdi Pune Maharashtra 411044 India
|
|
|
Primary Sponsor
|
| Name |
PDEAS College of Ayurved and Research Centre, Nigdi Pune |
| Address |
PDEAS College of Ayurved and Research Centre Rachana Sharir Department,Ground floor,Room no.1,Sector 25,Nigdi,Pune Maharashtra 411044 India
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vaishnavi Sanjayrao Dhole |
Ayurved Rugnalaya and Sterling Multispeciality Hospital |
Ayurved Rugnalaya and Sterling Multispeciality Hospital OPD No 125 Shalakyatantra Department Nigdi Pune Maharashtra
Pune
MAHARASHTRA |
8999520532
vaishnavi.dhole23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chairperson Ethics Committe College of Ayurved and Research Centre Akurdi Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H663||Other chronic suppurative otitis media. Ayurveda Condition: PUTIKARNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Prior-diagnosed patients of Putikarna, who have done recent HRCT scan - Temporal Bone.
2)Age group of 18-70 years, irrespective of sex, religion, occupation and socio-economic status. |
|
| ExclusionCriteria |
| Details |
1)History of trauma to ears and head.
2)Patients undergone ear surgery.
3)Patients having congenital anomalies of ear.
4)Pregnant womens, diagnosed patients of – HIV,T.B and other will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find structural involvement and changes in ears in patients of Putikarna using High-Resolution Computed Tomography (HRCT) of Temporal bone. |
1 time. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/06/2025 |
| 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
|
In Ayurveda,Karna is the site of Shravanendriya.The functional aspect of hearing.Putikarna has been mentioned in Ayurveda as “Karnaroga”.The disease occurring in ears.This ear disease is described by Acharya Sushruta and Vagbhat. Later Acharya Madhavnidan and Dalhan have also given the detailed aspects of the disease.According to these Acharya, the condition is characterized by foul discharge from the ears with or without pain is “Putikarna”.Despite its impact on hearing and quality of life, Putikarna remains poorly understood and unmanaged. As far as Putikarna is concerned, the study of structural involvements and changes can give the better understanding and insights to the surgeons and physicians for structural changes, severity and treatment outcomes.In Ayurvedic samhitas, the disease is elaborated with its treatment, but the anatomical structures involved in the Putikarna are clearly not mentioned.This study aims to identify the structures involved and structural changes in ears by providing crucial evidences, with the help of diagnostic examination – HRCT (Temporal Bone). |