| CTRI Number |
CTRI/2019/06/019903 [Registered on: 27/06/2019] Trial Registered Prospectively |
| Last Modified On: |
21/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of efficacy of karanja taila pichu and clotrimazaole 1% ear drops in the treatment of superficial fungal infection in external ear |
|
Scientific Title of Study
|
Comparative study of karanja taila pichu and clotrimazaole 1% ear drops in the management of otomycosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhinav Bhimrao Muley |
| Designation |
PG student |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Seth Tarachand Ramnath Charitable Hospital rastha peth pune
Rastha peth pune 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9921224420 |
| Fax |
|
| Email |
abhinavmuleypatil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Milind bhoi |
| Designation |
Guide Shalakyatantra |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya Rastha peth Pune
Rastha peth pune 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9823047544 |
| Fax |
|
| Email |
drmilindbhoi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Milind bhoi |
| Designation |
Guide Shalakyatantra |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya Rastha peth Pune
Rastha peth pune 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9823047544 |
| Fax |
|
| Email |
drmilindbhoi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya shalakyatantra department 2nd floor Rastha peth Pune 411011 |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya |
| Address |
Rastha peth pune 411011 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Abhinav Bhimrao muley |
Seth Tarachand Ramnath Charitable Hospital |
Opd building first floor opd no 15 rastha peth pune 411011
Pune
MAHARASHTRA |
9921224420
abhinavmuleypatil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional 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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clotrimazaole 1%ear drop |
2 drops twice a day for 14 days and follow up on 1,3,5,7,10,15 th day |
| Intervention |
Karanja taila pichu |
Karanja taila pichu application twice in day for 14 days and follow up on 1,3,5,7,10,15th day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from otomycosis and having atleast 3 symptoms of following aural itching, aural fullness,otalgia,otorrohoea, tinnitus
Presence of fungal debris on otoscopic examination |
|
| ExclusionCriteria |
| Details |
Pregnant women
Patients suffering from any debilitating diseases like TB,HIV
patients with other aural pathology like CSOM, ASOM, perforation of TM |
|
|
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 |
| To assess efficacy of karanja taila pichu in otomycosis |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To see adverse effects of karanja taila pichu in otomycosis
To assess antifungal action of karanja taila pichu in otomycosis
To assess antipruritic, antiinflammatory, healing property and antimicrobial action of the karanja taila |
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
28/06/2019 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Otomycosis is the superficial ,diffuse, fungal infection of the ear canal. Most commonly seen in adults and in tropical ckinates. Main cause of otomycosis in pune is swimming, aural hygiene, stagnation in aural cavity ,recurrent manipulation, recurrent washing of aural cavity, instillation of edible oil in ear cavity.Charaka had explained the kandughna,bhedaniya properties of karanja. |