| CTRI Number |
CTRI/2024/11/076637 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| 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
|
This clinical study will be performed to understand the effect of Gugguladi karnadhoopan in the management of otomycosis. |
|
Scientific Title of Study
|
A randomised controlled clinical trial to evaluate the efficacy of Gugguladi Karnadhoopan against Clotrimazole 1% ear drops in Otomycocis. |
| 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 Pratik Laxman Kumbhar |
| Designation |
PG scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs college of Ayurved and REsearch center 3rd floor shalakyatantra department sector 25 pradhikaran Nigdi pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9503235778 |
| Fax |
|
| Email |
pratikkumbhar2015@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha Pravin Pingale |
| Designation |
Associate professor shalakyatantra department |
| Affiliation |
PDEAs college of Ayurved and REsearch center |
| Address |
PDEAs college of Ayurved and REsearch center 3rd floor shalakyatantra department sector 25 pradhikaran Nigdi pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9028360353 |
| Fax |
|
| Email |
manishapingale.mp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manisha Pravin Pingale |
| Designation |
Associate professor shalakyatantra department |
| Affiliation |
PDEAs college of Ayurved and REsearch center |
| Address |
PDEAs college of Ayurved and REsearch center 3rd floor shalakyatantra department sector 25 pradhikaran Nigdi pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9028360353 |
| Fax |
|
| Email |
manishapingale.mp@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurveda and Research Centre Sector no 25 Pradhikaran Nigadi Pune
411044 |
|
|
Primary Sponsor
|
| Name |
PDEAs college of ayurved and research centre |
| Address |
PDEAs College of Ayurved and Research Centre 3rd floor Shalakyatantra departrment sector 25 Pradhikaran Nigadi Pune 411044 |
| Type of Sponsor |
Private 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 Pratik Kumbhar |
Ayurved Rugnalaya and sterling multispeciality hospital Nigadi Pune |
PDEAs college of Ayurved and REsearch center 3rd floor shalakyatantra department sector 25 pradhikaran Nigdi pune
MAHARASHTRA 411044 India
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9503235778
pratikkumbhar2015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H619||Disorder of external ear, unspecified. Ayurveda Condition: KARNASULAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Guggul Niryas and Nimb churna, Reference: Vaghbhat Samhita, Route: Otic, Dosage Form: Varti/ Suppository, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having minimum 3 symptoms of otomycosis-otalgia,itching,heaviness in ear,discharge from ear. |
|
| ExclusionCriteria |
| Details |
Patients having otomycosis with discharge due to secondary bacterial infections.
Patients having complications of aural polyp,maggots,perforated Tympanic membrane,cholesteatoma. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
the efficacy of gugguladi Karnadhoopan in comparison with clotrimazole 1% ear drops to reduce symptoms of otomycosis viz otalgia,itching,heaviness in ear,discharge from ear will be evaluated.
|
7 days treatment with follow-up on 8th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to assess the efficacy of gugguladi karnadhoopan in the management of otomycosis.
to assess the efficacy of clotrimazole 1% ear drop in the management of otomycosis.
To study the adverse effect if any. |
7 days treatment with follow-up on 8th day. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/02/2025 |
| 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="1"
Months="0"
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 one of the commonest infection seen in the external auditory canal . It is the superficial,diffused fungal infection of the ear canal with symptoms of Otalgia ,itching ,heaviness in ear and discharge from ear . Conventionally clotrimazole ear drops is the prescribed line of treatment . In ayurveda symptoms of otomycosis corelate with kaphaj karnashoola. The ratio of otomycosis is increasing day by day with increased instillation of different otic drops and use of antibiotics and corticosteroids . With random use of antibiotics many patients are becoming resistant to it. Dhoopan is the effective therapy for otomycosis. Gugguladi karnadhoopan is taken for study to check its effectiveness in comparison with conventional clotrimazole 1% ear drops in the treatment of otomycosis. |