| CTRI Number |
CTRI/2019/10/021649 [Registered on: 15/10/2019] Trial Registered Prospectively |
| Last Modified On: |
14/10/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Ear filling with medicated oil] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of new drug Hingwadi Taila in Karnashoola i.e. pain in ear. |
|
Scientific Title of Study
|
RANDOMIZED OPEN CONTROLLED CLINICAL STUDY TO ASSESS THE
EFFECT OF HINGVADI TAILA KARNAPOORAN IN KARNASHOOLA W.S.R.
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 |
Dhanshree Atmaram Pol |
| Designation |
PG Student |
| Affiliation |
Yashwant Ayurvedic College PostGraduate Training and Research Centre, Kodoli. Kolhapur |
| Address |
Resident, ShalakyaTantra Dept, Yashwant Ayurvedic College PostGraduate Training and Research Centre Kodoli, Kolhapur
Opposite to SDH Kodoli
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9960970421 |
| Fax |
|
| Email |
dhanupol.dp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kiran B Patil |
| Designation |
Associate Professor |
| Affiliation |
Yashwant Ayurvedic College PostGraduate Training and Research Centre, Kodoli. Kolhapur |
| Address |
Associate Professor, ShalakyaTantra Dept, Yashwant Ayurvedic College PostGraduate Training and Research Centre Kodoli, Kolhapur
Opposite to SDH Kodoli
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9823421568 |
| Fax |
|
| Email |
dr.kp1976@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kiran B Patil |
| Designation |
Associate Professor |
| Affiliation |
Yashwant Ayurvedic College PostGraduate Training and Research Centre, Kodoli. Kolhapur |
| Address |
Associate Professor, ShalakyaTantra Dept, Yashwant Ayurvedic College PostGraduate Training and Research Centre Kodoli, Kolhapur
Opposite to SDH Kodoli
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9823421568 |
| Fax |
|
| Email |
dr.kp1976@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College PostGraduate Training and Research Centre Kodoli, Kolhapur |
|
|
Primary Sponsor
|
| Name |
Dhanshree Atmaram Pol |
| Address |
Resident, ShalakyaTantra Dept, Yashwant Ayurvedic College PostGraduate Training and Research Centre Kodoli, Kolhapur |
| Type of Sponsor |
Other [SELF SPONSORED] |
|
|
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 |
| Dhanshree Atmaram Pol |
Yashwant Ayurvedic College PGT & RC |
ShalakyaTantra Dept. Opd 5 Kodoli Tal - Panhala 416114
Kolhapur
MAHARASHTRA |
9960970421
dhanupol.dp@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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hingvadi Taila |
10-12ml Ayurvedic medicated oil prepared by the traditional method is to be filled in the ear for 15mins for consecutive 15 days. |
| Comparator Agent |
Shrungberadi Taila |
10-12ml Ayurvedic medicated oil prepared by the traditional method is to be filled in the ear for 15mins for consecutive 15 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having sign and symptoms of Karnashoola.
Unilateral of Bilateral diffuse otitis externa.
Intact tympanic membrane. |
|
| ExclusionCriteria |
| Details |
Patients having any other karnarogas like Karnaguthak,Karnastrav.
Patient having any other ear diseases than Diffuse otitis externa.
Patient having any systemic disease expect hypertension.
Congenital anomalies of the ear. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction of pain in ear |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction of burning and itching sensation if any.. |
30 days |
|
|
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 |
|
Date of First Enrollment (India)
|
22/10/2019 |
| 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="0"
Months="3"
Days="3" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized, parallel-group, open-label, active-controlled trial for assessing the efficacy of Hingvadi taila karnapooran in karnshoola w.s.r. to diffuse otitis externa over another ayurvedic formulation shrungberadi taila in 60 patients, that will be conducted in one center in India. Patients irrespective of gender, occupation and economical class with the age ranging in between 18 to 60 will be selected for the trial by random allocation. Karnapoorana will be done daily for 15 days in which the assessment will be done on 5th,10th, 15thand 30th day of treatment. The primary outcome measures will be; reduction of pain in ear at 15 days. Secondary outcomes will be; reduction in itching and burning sensation if any. The conclusion will be drawn based on outcomes and result will be generated accordingly with the help of statistical findings |