| CTRI Number |
CTRI/2023/01/049156 [Registered on: 23/01/2023] Trial Registered Prospectively |
| Last Modified On: |
21/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Tila Taila (sesame oil) in management of Impacted Ear Wax |
|
Scientific Title of Study
|
An open lablled single arm clinical study to evaluate the efficacy of Tila Taila in the management of KARNAGOOTHA with special reference to IMPACTED EAR EAX |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajeev T |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri college of Ayurveda and Research Hospital |
| Address |
Department of PG studies in Shalakya tantra.
Sri Sri College Of Ayurvedic Science And Research
Hospital 21st KM, Kanakapura Main
Road Udayapura Post Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
7829086544 |
| Fax |
|
| Email |
rajeevraj0842@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naveen B S |
| Designation |
Professor and HOD |
| Affiliation |
Sri Sri college of ayurveda and Reasearch Hospital |
| Address |
Room No 305 Sri Sri College Of Ayurvedic Science And Research
Hospital Department Of Shalakya Tantra 21st KM, Kanakapura Main
Road Udayapura Post Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
9019508460 |
| Fax |
|
| Email |
myreports4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naveen B S |
| Designation |
Professor and HOD |
| Affiliation |
Sri Sri college of ayurveda and Reasearch Hospital |
| Address |
Room No 305 Sri Sri College Of Ayurvedic Science And Research
Hospital Department Of Shalakya Tantra 21st KM, Kanakapura Main
Road Udayapura Post Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
9019508460 |
| Fax |
|
| Email |
myreports4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College Of Ayurvedic Science And Research
Hospital Department Of Shalakya Tantra 21st KM, Kanakapura Main
Road Udayapura Post Bangalore |
|
|
Primary Sponsor
|
| Name |
Dr Rajeev T |
| Address |
Room No 305 Sri Sri College Of Ayurvedic Science And Research
Hospital Department Of Shalakya Tantra 21st KM, Kanakapura Main
Road Udayapura Post Bangalore |
| 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 Rajeev T |
Sri Sri college of Ayurveda science and Research Hospital |
OPD NO 6 Sri Sri College Of
Ayurvedic Science And
Research Hospital 21st
KM Kanakapura Main
Road Udayapura Post
560082
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
7829086544
rajeevraj0842@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committe |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H612||Impacted cerumen. Ayurveda Condition: KARNA-GUTHAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | karNapUraNam, करà¥à¤£à¤ªà¥‚रणमॠ| (Procedure Reference: Charaka samhita sutrastana 5th chapter , Procedure details: subject is supposed to instill Tila taila 4 drops Two times a day (Morning 8.30 am and 5pm Evening) in the affected ear.)
(1) Medicine Name: Tila Taila, Reference: Astangahrudaya Sutrastana 5th chapter Taila varga, Route: Otic, Dosage Form: Taila, Dose: 4(drops), Frequency: bd, Duration: 5 Days |
|
|
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Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects presenting with the classical features of Impacted ear wax.
2.Subjects within the age of 21 to 60 years irrespective of gender, occupation, religion, socio-economic status and duration of illness.
3.Subjects willing to sign informed consent
|
|
| ExclusionCriteria |
| Details |
1.Subjects suffering from Otitis externa
2.Subjects suffering from Otomycosis
3.Subjects suffering from CSOM and ASOM
4.Subjects suffering from Tympanic Membrane Perforation,
5.Any other Inflammation and space occupying lesions of EAC.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Objective Parameters
•Tuning fork test (Rinne’s test – 512Hz)
•Aural Endoscope
|
•Before treatment -0th day
•After treatment – 6th day
•1st Follow up – 10th day
•2nd Follow up - 15th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Ear pain
•Itching in the Ear
•Ear block
|
•Before treatment -0th day
•After treatment – 6th day
•1st Follow up – 10th day
•2nd Follow up - 15th day
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/01/2023 |
| Date of Study Completion (India) |
28/06/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
NEED OF THE STUDY: Karnagootha is one among Karnarogas. It can be correlated with impacted earwax or Cerumen can lead to symptoms such as hearing loss, tinnitus, pain, itching and vertigo. Cerumen or ear wax is a mixture of the glandular secretions from the lateral third of the ear canal and exfoliated squamous epithelium. It lubricates the ear canal, acts as a trap for dust, hair and insects. Normally cerumen is eliminated or expelled by self-cleansing mechanism which causes it to migrate out of the ear canal assisted by jaw movements. Taila prakledana has been mentioned classically as the first stage of Karnagootha Chikitsa.Tila taila is the best choice of drug due to its Vatakaphaharatva, Snigdha, Sukshma, Tikshna and Ushna properties, which can help in Kledana and Shodhana of Karnagootha. Very few studies have been done with respect to management of Karnagootha (impacted wax). Among them published researches are still minimum. Hence, an effort has been made in this present single armed clinical study to evaluate the efficacy of Tila taila in the management of Karnagootha. |