| CTRI Number |
CTRI/2025/01/078879 [Registered on: 16/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of kaphajkarnashoola with Lakshadigana kwatha karnaprakshalana and Rasanjana Madhu in comparison to Fluconazole 0.3% Ear drops. |
|
Scientific Title of Study
|
A Randomized Controlled Trial To Evaluate The Efficacy Of
Lakshadigana kwatha karnaprakshalana and Rasanjana Madhu
karnapoorna in comparison to Fluconazole 0.3 percent Ear drops In The
Treatment Of kaphajkarnashoola - 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 Abhilasha |
| Designation |
Phd Scholar |
| Affiliation |
SKAU, Krukshetra |
| Address |
Officers colony
Kurukshetra
HARYANA
132001
India |
| Phone |
8535080272 |
| Fax |
|
| Email |
docabhi53@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashu |
| Designation |
Professor and HOD |
| Affiliation |
SKAU, Kurukshetra |
| Address |
SKAU Kurukshetra
Kurukshetra
HARYANA
136038
India |
| Phone |
9416553131 |
| Fax |
|
| Email |
drashukataria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashu |
| Designation |
Professor and HOD |
| Affiliation |
SKAU, Kurukshetra |
| Address |
SKAU Kurukshetra
Kurukshetra
HARYANA
136038
India |
| Phone |
9416553131 |
| Fax |
|
| Email |
drashukataria@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Abhilasha |
| Address |
House no 55 officers colony, karnal (Haryana) Pin code 132001 |
| 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 Abhilasha |
BDM College of Ayurveda and Hospital , Jhajjar |
OPD ENT, Ground Floor
Jhajjar
HARYANA |
8535080272
docabhi53@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:H618||Other specified disorders of external ear. Ayurveda Condition: KARNA-KANDU, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | karNapUraNam, करà¥à¤£à¤ªà¥‚रणमॠ| (Procedure Reference: Sushrut Uttar Tantra, Procedure details: Lakshadigana kwath karn prakshalan will be done before Rasanjana Madhu karnapoorna)
(1) Medicine Name: Rasanjana Madhu, Reference: Sushrut Uttar Tantra 20/6, Route: Otic, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 3(drops), Frequency: tds, Duration: 20 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Fluconazole Ear Drop | 0.3 percent flucanozole ear drops TDS |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient presenting with sign and symptoms of otomycosis.
2. Lakshana of kaphajkarnashoola.
3. Patients willing to give conse |
|
| ExclusionCriteria |
| Details |
1. Patient having perforated tympanic membrane.
2. Patient of CSOM and ASOM.
3. Patient suffering from systemic diseases like uncontrolled DM, HIV, Hypothyroidism.
4. Immunocompetent and immunocompromised. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in the sign and the symptoms of the
kaphajkarnashoola – Otomycosis is expected. |
40 Days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
02/02/2026 |
| 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="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In the previous research done a significant result has been observed in treating the sign and the symptoms of the otomycosis using different Ayurvedic treatment modalities. Even after the extensive research work has been carried out, Otomycosis is still a challenging disease and remains one of the most established risk factor for the serious complications such as otorrhoea, tympanic perforations and deafness. Hence it is decided to continue the study on otomycosis so as to prove the efficacy of new Ayurvedic intervention and to study it on large population so as to generate more data to evaluate the efficacy of new Ayurveda drug in treating the Otomycosis |