| CTRI Number |
CTRI/2023/08/056143 [Registered on: 04/08/2023] Trial Registered Prospectively |
| Last Modified On: |
03/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To See the Effect of Yavadi Karna Dhoopana, Arka Taila topically and Triphala Guggulu orally in Patients of Karna Srava (Otomycosis) |
|
Scientific Title of Study
|
CLINICAL EVALUATION OF YAVADI KARNA DHOOPANA, ARKA TAILA AND TRIPHALA GUGGULU IN KARNASRAVA (OTOMYCOSIS) |
| 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 Arun Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Uttarakhand Ayurved University Harrawala Dehradun |
| Address |
OPD NO 5 PG Department of Shalakya Tantra Rishikul Campus Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9634918909 |
| Fax |
|
| Email |
drarun2004@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Uttarakhand Ayurved University Harrawala Dehradun |
| Address |
OPD NO 5 PG Department of Shalakya Tantra Rishikul Campus Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9634918909 |
| Fax |
|
| Email |
drarun2004@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meena |
| Designation |
PG Scholar |
| Affiliation |
Uttarakhand Ayurved University Harrawala Dehradun |
| Address |
OPD NO 5 PG Department of Shalakya Tantra Rishikul Campus Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9991328725 |
| Fax |
|
| Email |
meenasheokand734@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD no 5 Department of Shalakya Tantra Rishikul Campus Uttarakhand Ayurved University Haridwar |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurved University |
| Address |
Uttarakhand Ayurved University Harrawala Dehradun |
| Type of Sponsor |
Government medical college |
|
|
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 Meena |
Rishikul Campus Haridwar |
OPD NO 5 Shalakya Tantra Department Rishikul Campus Haridwar Uttarakhand Ayurved University Harrawala Dehradun
Hardwar
UTTARANCHAL |
9991328725
meenasheokand734@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Uttarakhand Ayurved University, Rishikul Campus Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H608||Other otitis externa. Ayurveda Condition: KARNA-SRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | karNadhUpanam, करà¥à¤£à¤§à¥‚पनमॠ| (Procedure Reference: Ashtanga Sangraha, Procedure details: there will be three sitttings of 5-5 days with a gap of three days in each sitting (for 5 minutes))
(1) Medicine Name: Triphala Guggulu, Reference: Chakra Dutta, Route: Oral, Dosage Form: Guggulu, Dose: 1(g), Frequency: bd, Duration: 21 Days(2) Medicine Name: Arka Taila, Reference: Gada Nigraha, Route: Otic, Dosage Form: Taila, Dose: 2(drops), Frequency: tds, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with sign & symptoms of Karnasrava (Otomycosis) like Discharge, Pain, Itching and Feeling of ear blockage- Sravetu puyam |
|
| ExclusionCriteria |
| Details |
Patients of Uncontrolled Diabetes mellitus/ Meningitis/ Tuberculosis/ Pregnant women/ Tympanic membrane perforation and Invasive temporal bone infection |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in sign & symptoms of karnasrava like Discharge, Pain, Itching & Feeling of ear blockage |
1st 9th 15th 21st |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of debris present in external auditory canal |
1st 9th 15th 21st |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
18/08/2023 |
| 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
|
Among 28 ear diseases mentioned by Acharya Sushruta Karnasrava is one of them . Available treatment protocols for Otomycosis in modern system of medicine relies upon anti-fungal agents, antibiotics and steroids.Otomycosis is a frustrating entity for both patients and otolaryngologists as it requires long term treatment and medications used for its treatment has limitations like itchy skin, burning, stinging, swelling, irritation, dizziness, loss of hearing and unusual taste in mouth.
So the present study will be planned to study the effect of Ayurvedic formulation on Karnasrava.
Case will be selected from OPD/IPD of Rishikul Campus Hospital, U.A.U, Haridwar(UK) INDIA.
A written informed consent will be obtained after counselling of patients participating in the study.
Patients will be treated with Dhoopana therapy, local application and oral drug.
If any ADR is seen, it shall be at once reported at ADR Cell. |