| CTRI Number |
CTRI/2025/05/087236 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
26/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Clinical Study To See The Efficacy Of Karnadhoopan and Karanpichu In The Management of karnasrava (ear discharge) |
|
Scientific Title of Study
|
A RANDOMIZED COMPARATIVE CLINICAL TRIAL TO EVALUATE THE EFFICACY OF AAMRADIPALLAVA TAILA KARNAPICHU AND GUGGULUADI KARNA DHOOPANA WITH GANDHAKA RASAYANA IN KARNASRAVA W.S.R. TO CHRONIC SUPPURATIVE OTITIS MEDIA (CSOM) |
| 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 Aparna sharma |
| Designation |
Professor of shalakya Tantra Department |
| Affiliation |
National Institute Of Ayurveda, Jaipur |
| Address |
Department Of Shalakya Tantra, National Institute Of Ayurveda, Joravar Singh Gate,Amer Road, Jaipur Rajasthan 302002, India
Department Of Shalakya Tantra, National Institute Of Ayurveda,Jaipur Rajasthan 302002, India
Jaipur
RAJASTHAN
302002
India |
| Phone |
8955688129 |
| Fax |
|
| Email |
appu07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna sharma |
| Designation |
Professor of shalakya Tantra Department |
| Affiliation |
National Institute Of Ayurveda, Jaipur |
| Address |
Department Of Shalakya Tantra, National Institute Of Ayurveda, Joravar Singh Gate,Amer Road, Jaipur Rajasthan 302002, India
Department Of Shalakya Tantra, National Institute Of Ayurveda,Jaipur Rajasthan 302002, India
Jaipur
RAJASTHAN
302002
India |
| Phone |
8955688129 |
| Fax |
|
| Email |
appu07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr pooja chouhan |
| Designation |
PG SCHOLAR, |
| Affiliation |
National Institute Of Ayurveda,Jaipur |
| Address |
Department Of Shalakya Tantra, National Institute Of Ayurveda, Joravar Singh Gate,Amer Road, Jaipur Rajasthan 302002, India
Department Of Shalakya Tantra, National Institute Of Ayurveda,Jaipur Rajasthan 302002, India
Jaipur
RAJASTHAN
302002
India |
| Phone |
7987427025 |
| Fax |
|
| Email |
poojachouhan5868@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Ayurveda,Amer Road, Jaipur 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute Of AyurvedaJaipur |
| Address |
National Institute Of Ayurveda, Amer Road,Joravar Singh Gate ,Jaipur 302002,Rajasthan 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 pooja chouhan |
National Institute Of Ayurveda, Jaipur |
OPD Num.13 P.G.Department of shalakya tantra Jaipur Rajasthan
Jaipur
RAJASTHAN |
7987427025
poojachouhan5868@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute Of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H729||Unspecified perforation of tympanic membrane. Ayurveda Condition: KARNA-SRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Karnapichu | (Procedure Reference: Ref. Sushrut Samhita Uttar Tanta -21/47, Procedure details: • pichuvarti (cotton wick) dipped in luke warm oil medicine approx 8 to16 drops.
• Pichu varti is a thick cotton soaked in medicated Taila and placed in
Karna.
• pichuvarti inserted into the ear canal with help of probe and forceps.
• karna pichu absorb fluid / pus discharge in ear canal.
)
(1) Medicine Name: Gandhaka rasayana , Reference: Ref. Yogaratnakar Rasayanadhikara by Shodhita Gandhaka, Route: Oral, Dosage Form: Varti/ Suppository, Dose: 500(mg), Frequency: bd, Duration: 30 Days | | 2 | Comparator Arm | Procedure | - | karNadhUpanam, कर्णधूपनम् | (Procedure Reference: Ref. Sushrut Samhita sutra sthana 5/18, Procedure details: • First of all yavakuta churna of karna dhoopana dravyas
• Dravyas is Put on karnadhoopan yantra then yantra is kept on flame.
• when dhoopan (fumes) is coming out from yantra. A funnel with thin rubber tube is Put on yantra.
• patient take dhoopana with tubes other end in external auditory canal for 2 minutes. The fumes are enter the ear canal gently.
)
(1) Medicine Name: Gandhaka rasayana , Reference: Ref. Yogaratnakar Rasayanadhikara by Shodhita Gandhaka, Route: Oral, Dosage Form: Varti/ Suppository, Dose: 500(mg), Frequency: bd, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients fulfilling the diagnostic criteria which are based on sign and symptoms of Karnasrava as well as CSOM -like
-Ear discharge (active /inactive)
-hearing loss
-perforation (tubotympanic perforation )
2. Patient comes with other associated symptoms along with ear discharge and perforation like –Karnakandu (Ear itching),karnanadha (Tinnitus), karnasula
|
|
| ExclusionCriteria |
| Details |
1. Patients aged below 18 and above 60 years will be excluded.
2. Patients having atticoantral type of CSOM
3. Total perforation and traumatic perforation of tympanic membrane.
4. Patients suffering from any chronic debilitating disease and cases which required surgical intervention will be excluded from study.
5. Pregnant and lactating women
6. Patient with having malignant otitis externa
7. CSOM with complication like – acute mastoiditis, Petrositis, facial paralysis, adenoids, tonsillitis, labyrinthitis etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| -Changes in the karnasrava |
after completion of 1 month of therapy
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| changes in the assessment scoring / grading |
after completion of 1 month of therapy |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
25/07/2025 |
| 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 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
|
A RANDOMIZED COMPARATIVE
CLINICAL TRIAL TO EVALUATE THE EFFICACY OF AAMRADIPALLAVA TAILA KARNAPICHU AND
GUGGULUADI KARNA DHOOPANA WITH GANDHAKA RASAYANA IN KARNASRAVA
W.S.R. TO CHRONIC SUPPURATIVE OTITIS MEDIA (CSOM) |