| CTRI Number |
CTRI/2016/05/006935 [Registered on: 13/05/2016] Trial Registered Retrospectively |
| Last Modified On: |
15/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Karnashoola with Honey |
|
Scientific Title of Study
|
A CLINICAL STUDY OF KARNA SHOOLA W.S.R. TO OTOMYCOSIS AND ITS MANAGEMENT WITH HONEY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amishaben Jayantilal Patel |
| Designation |
MS 2nd |
| Affiliation |
IPGT AND RA GAU JAMNAGAR |
| Address |
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
India
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9723273584 |
| Fax |
|
| Email |
amisha.patel1311@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D B Vaghela |
| Designation |
Asst. Professor |
| Affiliation |
IPGT AND RA GAU JAMNAGAR |
| Address |
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
India
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9825407899 |
| Fax |
|
| Email |
drvaghela@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amishaben Jayantilal Patel |
| Designation |
MS 2nd |
| Affiliation |
IPGT AND RA GAU JAMNAGAR |
| Address |
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
India
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9723273584 |
| Fax |
|
| Email |
amisha.patel1311@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University
Jamnagar – 361008 |
|
|
Primary Sponsor
|
| Name |
INSTITUTE FOR POST GRADUATION TEACHING AND RESEARCH IN AYURVEDA |
| Address |
INSTITUTE FOR POST GRADUATION TEACHING AND
RESEARCH IN AYURVEDA OPP. CITY B POLICE STATION PN
MARG JAMNAGAR |
| 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 |
| Amishaben Jayantilal Patel |
Department of Shalakya Institute for Post Graduate Teaching and Research in Ayurveda |
Institute for Post
Graduate Teaching and
Research in Ayurveda
Gujarat Ayurved
University Jamnagar –
361008 Jamnagar
Jamnagar
GUJARAT
Jamnagar
GUJARAT |
9723273584
amisha.patel1311@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H603||Other infective otitis externa, (2) ICD-10 Condition: H603||Other infective otitis externa, Patients suffering from Otalgia ear discharge fungal infection i.e.Otomycosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Intervening 4 drops of honey for 7 days after dry mopping of EAC |
| Comparator Agent |
Group B |
Clotrimazole 4 drops thrice a day for 1-3 weeks. |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the diagnostic criteria which are based on signs and symptoms of Otomycosis (Karna Shool) .i.e. pain, itching, discharge, fungal hyphae in Microscopic Examination, inflammation & ulcer in EAC. |
|
| ExclusionCriteria |
| Details |
• Patients aged below ten years and above seventy years will be excluded.
• Patients having perforated tympanic membrane.
• Patients having atticoantral type of CSOM.
• Patients suffering from any chronic debilitating disease like Ca, Koch’s, HIV etc will
be excluded from study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| management of fungal infection from ear |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| establish normal functin of ear |
7 Days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
09/04/2015 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
On the Otomycosis disease there are some previous works were done. But among them no one work were done on Madhu. Madhu has Ruksh, Vranashodhak, Vranaropan, Sukshmamarganusari, Tridosh Shaman, fungicidal, bacteriocidal properties. EAC develop inflammation & erosion with blackish / whitish thick discharge along with profuse pain, itching which is similar to Dushta Vrana in Ayurvedic literature. Honey in such condition can be a potent , cost effective safe modality is a topical medication. With this hypothesis the present study is planned to evaluate it’s efficacy in Otomycosis. |