| CTRI Number |
CTRI/2019/09/021448 [Registered on: 30/09/2019] Trial Registered Prospectively |
| Last Modified On: |
27/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of amrapallava taila in the management of karnasrava |
|
Scientific Title of Study
|
Randomised control study of amrapallava taila in the management of karnasrava with special reference to 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 Monish Rangate |
| Designation |
Ms shalakyatantra |
| Affiliation |
annasaheb dange ayurved medical college ashta |
| Address |
annasaheb dange ayurved medical college ashta dist sangli
annasaheb dange ayurved medical college and post graduation research training center ashta dist sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9923429223 |
| Fax |
|
| Email |
dr.monishrangate@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr Monish Rangate |
| Designation |
Ms shalakyatantra |
| Affiliation |
annasaheb dange ayurved medical college ashta |
| Address |
annasaheb dange ayurved medical college ashta dist sangli
annasaheb dange ayurved medical college and post graduation research training center ashta dist sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9923429223 |
| Fax |
|
| Email |
dr.monishrangate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr Monish Rangate |
| Designation |
Ms shalakyatantra |
| Affiliation |
annasaheb dange ayurved medical college ashta |
| Address |
annasaheb dange ayurved medical college ashta dist sangli
annasaheb dange ayurved medical college and post graduation research training center ashta dist sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9923429223 |
| Fax |
|
| Email |
dr.monishrangate@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shree Annasaheb dange ayurved medical college ashta dist sangli tal Walwa 416301 |
|
|
Primary Sponsor
|
| Name |
Hon Shree Annasaheb Dange yurved medical college ashta |
| Address |
Hon Shree Annasaheb Dange ayurved medical college and post graduation research training center ashta |
| 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 maduri tukaram tirmare |
Hon Shree Annasaheb Dange ayurved medical college ashta |
Hon Shree Annasaheb Dange ayurved medical college and post graduation research training center ashta dist sangli
Sangli
MAHARASHTRA |
9665229373
madhuri.t.1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H603||Other infective otitis externa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1% clotrimazole ear drop 2to 3 drops |
1% clotrimazole ear drop 2to3 drops |
| Intervention |
Amrapallava taila karnapoorana in karnasrava
|
Amrapallava taila karnapoorana 8 to 10drops for 2 minits |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient between age 18 to 60 years of both sex
shows classical sings and symptoms of karnasrava otomycosis
patient having fungal mass and debris in external auditory canal |
|
| ExclusionCriteria |
| Details |
patient suffering from systemic disease like diabetic tuberculosis
patient age below 18 years and above 60 years
patient having perforated tympanic memebrane pathology for example acute suppurative otitis media
and chronic suppurative otitis media
patient with having malignant otitis externa |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Amrapallva tail in karnasrava |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the mode of action of amrapallava taila |
10 days |
|
|
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
30/09/2019 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Clinical research project named as " Randomised control study of amrapallava taila in the management of karnasrava with special refrence to otomycosis. will be conducted with support of Hon shri Annasaheb Dange Ayurved medical college Ashta |