| CTRI Number |
CTRI/2024/08/072419 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
01/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of Otomycosis (Kaphaja Karna Roga) with Vachalashunadi Taila Ear Drops and 1% Clotrimazole Ear Drops |
|
Scientific Title of Study
|
An Open Label Randomized Controlled Clinical Study On The Evaluation Of The Efficacy Of Vachalashunadi Taila Ear Drops In Otomycosis (Kaphaja Karna Roga) |
| 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 Thoppe Sridhar Vayishnavi |
| Designation |
Post Graduate Scholar |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
OPD No.4 , Department of Shalakya Tantra , JSS Ayurveda Medical College and Hospital , Lalithadripura Road , Mysore , Karnataka
Mysore
KARNATAKA
570028
India |
| Phone |
9844858669 |
| Fax |
|
| Email |
drvayishnavisridhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gavimath Shivanand |
| Designation |
Professor and HOD |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
OPD No.4 , Department of Shalakya Tantra , JSS Ayurveda Medical College and Hospital , Lalithadripura Road , Mysore, Karnataka , India
Mysore
KARNATAKA
570028
India |
| Phone |
9448211075 |
| Fax |
|
| Email |
shiva.shalakya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Thoppe Sridhar Vayishnavi |
| Designation |
Post Graduate Scholar |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
OPD No.4 , Department of Shalakya Tantra , JSS Ayurveda Medical College and Hospital , Lalithadripura Road , Mysore , Karnataka , India
Mysore
KARNATAKA
570028
India |
| Phone |
9448211075 |
| Fax |
|
| Email |
shiva.shalakya@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Ayurveda Medical College and Hospital, Lalithadripura Road, Mysore, Karnataka , India. Pincode - 570028 |
|
|
Primary Sponsor
|
| Name |
Dr Thoppe Sridhar Vayishnavi |
| Address |
JSS Ayurveda Medical College and Hospital, Lalithadripura Road, Mysore, Karnataka, India |
| Type of Sponsor |
Other [(Self) ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Thoppe Sridhar Vayishnavi |
JSS Ayurveda Medical College and Hospital |
OPD No.4, Department of Shalakya Tantra, JSS Ayurveda Medical College and Hospital, Lalithadripura Road, Mysore - 570028
Mysore
KARNATAKA |
9844858669
drvayishnavisridhar@gmail.com |
| Dr Thoppe Sridhar Vayishnavi |
JSS Medical Hospital |
OPD No.1059 , Department of ENT , JSS Medical Hospital, Mahatma Gandhi Road, Fort Mohalla, Mysore - 570004
Mysore
KARNATAKA |
9844858669
drvayishnavisridhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, JSS Ayurveda Medical College, Mysore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H624||Otitis externa in other diseases classified elsewhere. Ayurveda Condition: KARNAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vachalashunadi Taila , Reference: Sahasrayoga , Route: Topical, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | 1% Clotrimazole Ear Drops | 2 Drops TID for 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects of any gender irrespective of religion, race, occupation presenting with the signs
and symptoms of Otomycosis (Kaphaja Karna roga) described as per Ayurveda and modern
science
2.Subjects between the age group of 18 – 70 years
3.Subjects who consent for participation in the study |
|
| ExclusionCriteria |
| Details |
1.Subjects diagnosed with Active Otitis Media, Tympanic Membrane Perforation, CSOM,
Otitis externa, Cholesteatoma and previous history of ear surgery
2.Subjects diagnosed with systemic diseases like Tuberculosis, Malignancies, uncontrolled
Diabetes Mellitus
3.Subjects who are a known case of Immunocompromised conditions, Fungal diseases
elsewhere in the body |
|
|
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 |
Management of Otomycosis in Ear
Negative Potassium Hydroxide Test |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the symptoms - Itching, Feeling of fullness in the ear, Earache, Ear Discharge |
14 Days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
26/08/2024 |
| 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="3"
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
|
Otomycosis is described as the superficial and diffuse fungal infection of the external auditory canal. It is more commonly found in tropical and subtropical regions. The fungal species that are frequently involved are the Aspergillus niger and Candida albicans. The symptoms observed are pruritis, feeling of fullness in the ear canal, pain, discharge from the ears and hearing loss. In Ayurveda, Karna rogas has been explained by various Acharyas. Avasyaya (exposure to cold environment), Jalakreeda (swimming), Mithya yogena shastrasya (improper instrumentation) and Shira snana (regularly taking head bath) have been described as the Nidanas (causative factors) for the Karna rogas. Acharya Charaka explained four Karna rogas, out of which Kaphaja Karna roga includes symptoms such as Kandu (itching), Vaishrutya (decreased hearing), Shukla shruti (whitish discharge) and Alpa ruk (mild pain). The main line of treatment of Kaphaja Karna roga includes Kaphahara Upakramas such as Teekshna nasya, Teekshna dhooma, Nadisweda, Vamana etc. Sthanika (local) Upakramas include Karna parimarjana, Karna poorana, Karna pichu. In the Modern science, the treatment of Otomycosis includes local debridement, topical and systemic antifungal medications. Topical antifungal drugs include clotrimazole, nystatin etc. These drugs even though are effective in reducing the signs and symptoms of the disease, most of the cases remain uncured completely and relapsing of the disease is common. Hence, the present research is undertaken to evaluate the effect of Vachalashunadi Taila ear drops and to compare the efficacy with 1% Clotrimazole ear drops in Otomycosis (Kaphaja Karna roga). |