| CTRI Number |
CTRI/2024/12/078428 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic management of fungal infection of ear. |
|
Scientific Title of Study
|
Effect of Gomutra Arka Karnapoorana on Fungal growth of Otomycosis w. r. t Karnasrava - A Randomised Controlled Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
shashikala khadabadi |
| Designation |
Associate professor |
| Affiliation |
Shree jagadguru Gavisiddheshwara Ayurvedic medical collage and hospital |
| Address |
Shalakyatantra OPD, Room No 41
Gavimath Campus, Koppal
Koppal
KARNATAKA
583231
India |
| Phone |
08951315404 |
| Fax |
|
| Email |
shashikalakhadabadi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savita S Angadi |
| Designation |
Professor |
| Affiliation |
KAHER’s Shri B.M.K Ayurveda Mahavidyalaya |
| Address |
Shahapur
Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
7411213286 |
| Fax |
|
| Email |
savitaangadi484@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
shashikala khadabadi |
| Designation |
Associate professor |
| Affiliation |
shree jagadguru Gavisiddheshwara Ayurvedic medical collage and hospital |
| Address |
Shalakyatantra OPD, Room No 41
Gavimath Campus
, Koppal
Koppal
KARNATAKA
583231
India |
| Phone |
8951315404 |
| Fax |
|
| Email |
shashikalakhadabadi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Jagdguru Gavisiddheswara Ayurveda Medical college ,Koppal, Karnataka, 583231 India |
|
|
Primary Sponsor
|
| Name |
Dr Shashikala Khadabadi |
| Address |
Shalakyatantra OPD, Room No 41
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical college and Hospital, Koppal 583231 |
| 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 Shashikala Khadabadi |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical college and hospital |
Shalakytantra OPD, Room No 41
Gavimath road
Koppal
KARNATAKA |
8951315404
shashikalakhadabadi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER ethical committee(Human) for Ph.D research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H603||Other infective otitis externa. Ayurveda Condition: KARNA-SRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | karNapUraNam, करà¥à¤£à¤ªà¥‚रणमॠPradhan Karma | (Procedure Reference: sharangadhara samhita , Procedure details: Patients will be treated using GomutraArka karnapoorana for 100 matra kaala(2.4mins) for 15 days with the interval of 5 days)
(1) Medicine Name: Gomutra arka , Reference: sushruta samhita , Route: Topical, Dosage Form: Arka, Dose: 1(ml), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm | Procedure | - | karNapUraNam, करà¥à¤£à¤ªà¥‚रणमॠ| (Procedure Reference: sharangadhara samhita , Procedure details: Patients will be treated using Arka taila karnapoorana daily for 100 matra kaala(2.4mins) for 15 days with the interval of 5 days)
(1) Medicine Name: Arka taila , Reference: sharangadhara samhita , Route: Topical, Dosage Form: Taila, Dose: 1(ml), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed cases of otomycosis
2. Willing to give consent
|
|
| ExclusionCriteria |
| Details |
1. Patient with Otitis Media.
2. Other otitis externa.
3. Post-operative cases of ear surgery.
4. Structural ear anomalies that make assessment of therapeutic response difficult.
5. Uncontrolled diabetes mellitus and Hypertension
6. Known cases of other systemic illness
7. Pregnancy and lactating women
8. Patients using concomitant medicines that may interfere with the study evaluations |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in fungal growth |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of itching in ear |
15 days |
|
|
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 3 |
|
Date of First Enrollment (India)
|
15/01/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Effect of Gomutra Arka Karnapoorana on Fungal growth of Otomycosis w. r. t Karnasrava - A Randomised Controlled Clinical Trial Otomycosis is a common superficial fungal infection that affects the external auditory canal (EAC). The infection is present globally, with prevalence ranging from 9% to 30% in patients with the signs and symptoms of EAC infection. The most common causative agents of otomycosis are Molds of the genus Aspergillus and yeasts of the genus Candida, particularly Aspergillus (A.) Niger complex and Candida (C.) albicans. Intense itching, discomfort or pain in the ears, watery discharge with musty odour, reduced hearing and fungal mass are the main signs and symptoms of otomycosis. Treatment of otomycosis includes local therapy as Aural toileting and anti- fungal agents with steroid formulations. This line of treatment can revert the otomycosis which involves some potential side effects. The clinical features of otomycosis are similar to karnasrava explained in Ayurveda classics. Treatment protocol of Karnasraava includes shirovirechna, dhupana, purana, pramarjana, dhavana (Raajavrukshadigana ,Surasaadigana),avachurnana (manashila, lodhra) and Karanpurana . In this study Gomutra arka, which has antifungal property is chosen for the karnapoorana. Arka taila karnapoorana is taken as control group. Methodology: clinically diagnosed patients of otomycosis fulfilling inclusion criteria will be Randomly allocated to study groups using Computerised Randomization chart with informed consent. Patients allocated to Group A(Trial) will be treated using GomutraArka karnapoorana and Group B (Control) will be treated with Arka taila karnapoorana daily for 100 matra kaala(2.4mins) for 15 days with the interval of 5 days. Patients will be assessed on day 1,15,30 and 45 for itching scale, otalgia, otorrhia and fungal mass. Any ADR will be addressed.
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