| CTRI Number |
CTRI/2022/12/048291 [Registered on: 20/12/2022] Trial Registered Prospectively |
| Last Modified On: |
16/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Filling both the ears (karnapooran)with nagaradadi tail in karnashoola |
|
Scientific Title of Study
|
OPEN RANDOMISED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFECT OF NAGRADI TAILA KARNAPOORAN IN KARNASHOOLA WITH SPECIAL REFERENCE TO THE DIFFUSE OTITIS EXTERNA.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amarjeet Ankush chavan |
| Designation |
PG scholar |
| Affiliation |
Maharashtra University of health sciences nashik |
| Address |
Yashwant Ayurvedic medical College PGT and RC kodoli shalakyatantra department OPD no 11
Yashwant Ayurvedic medical College PGT and RC kodoli shalakyatantra department
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8087415117 |
| Fax |
|
| Email |
abjtchavan007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran patil |
| Designation |
PG Guide Professor |
| Affiliation |
Maharashtra University of health sciences nashik |
| Address |
Yashwant Ayurvedic medical College PGT and RC kodoli shalakyatantra department OPD no 11
Yashwant Ayurvedic medical College PGT and RC kodoli shalakyatantra department
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7020519271 |
| Fax |
|
| Email |
dr.kp1976@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran patil |
| Designation |
PG Guide Professor |
| Affiliation |
Maharashtra University of health sciences nashik |
| Address |
Yashwant Ayurvedic medical College PGT and RC kodoli shalakyatantra department OPD no 11
Yashwant Ayurvedic medical College PGT and RC kodoli shalakyatantra department
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7020519271 |
| Fax |
|
| Email |
dr.kp1976@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic medical College PGT and RC kodoli dist Kolhapur Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Amarjeet Ankush chavan |
| Address |
Yashwant Ayurvedic hospital kodoli kolhapur |
| 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 Amarjeet Ankush chavan |
Yashwant Ayurvedic medical College kodoli |
Yashwant Ayurvedic medical College PGT and RC kodoli shalakyatantra department OPD no 11 kodoli dist Kolhapur
Kolhapur
MAHARASHTRA |
8087415117
abjtchavan007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H608||Other otitis externa. Ayurveda Condition: Ayurveda , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | karNapUraNam, करà¥à¤£à¤ªà¥‚रणमॠ| (Procedure Reference: Bharat bhaishyghya ratnakar, Procedure details: Nagradi tail karnapooran and shrungberadi tail karnapooran 10drops in each ear for 15days )
(1) Medicine Name: Nagradi tail , Reference: Shrungberadi tail , Route: Ocular, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 10(drops), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having signs and symptoms of karnashoola .unilateral or bilateral diffuse otitis externa.Intact tymapnic membrane |
|
| ExclusionCriteria |
| Details |
Patient having any other karnagatrogas than karnashool . patient having perforated tympanic membrane |
|
|
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 |
| Decrease the karna ruja and strava |
Decrease the karna ruja karna kandu karna strava in 2weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease the symptoms like Karna ruja ,karna kandu ,itching ,karna strava |
18 months |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
22/12/2022 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a open Randomised controlled clinical study to evaluate the effect of nagradi tail karnapooran in karnashoola w.s.r to diffuse otitis externa .study will be carried in OPD of shalakyatantra department of Yashwant Ayurvedic medical College and hospital kodoli.The observation would be drawn on the basis of the symptoms after treatment given. |