CTRI Number |
CTRI/2019/09/021151 [Registered on: 09/09/2019] Trial Registered Prospectively |
Last Modified On: |
06/09/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
Ayurvedic treatment protocol of Poothikarna along with Nirgundyadi thaila karnapoorana in Otomycosis |
Scientific Title of Study
|
Effectiveness of Classical Ayurvedic Protocol of Poothikarna Along With Nirgundyadi Thaila Karnapoorana in 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 Aswathy Krishna S |
Designation |
PG Scholar |
Affiliation |
Amrita School of Ayurveda |
Address |
Department of Salakyatantra
Amrita School of Ayurveda
Clappana P O
Kollam
690525
Kollam KERALA 690525 India |
Phone |
8129896236 |
Fax |
|
Email |
aswathykrishna3891@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr K Sivabalaji |
Designation |
Assistant Professor |
Affiliation |
Amrita School of Ayurveda |
Address |
Department of Salakyatantra
Amrita School of Ayurveda
Clappana P O
Kollam
690525
Kollam KERALA 690525 India |
Phone |
7559027947 |
Fax |
|
Email |
balajisiva85k@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr K Sivabalaji |
Designation |
Assistant Professor |
Affiliation |
Amrita School of Ayurveda |
Address |
Department of Salakyatantra
Amrita School of Ayurveda
Clappana P O
Kollam
690525
Kollam KERALA 690525 India |
Phone |
7559027947 |
Fax |
|
Email |
balajisiva85k@gmail.com |
|
Source of Monetary or Material Support
|
Amrita School of Ayurveda
Clappana P O
Kollam
690525 |
|
Primary Sponsor
|
Name |
Amrita School of Ayurveda |
Address |
Amrita School of Ayurveda
Clappana P O
Kollam
690525 |
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 Aswathy Krishna S |
Amrita School of Ayurveda |
Salakyatantra OPD
Department of Salakyatantra
Amrita School of Ayurveda
Clappana P O
Kollam
690525 Kollam KERALA |
8129896236
aswathykrishna3891@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committe Amrita Institute of Medical Sciences Kochi |
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 |
NA |
NA |
Intervention |
Sadyosneha and virechana
Ear Mopping
karnadhoopanam
Pratimarsha nasya
Madhupramarjanam
Karnapooranam
|
After virechana with Avipathy churna 20 gm with lukewarm water on first day for next five days ear mopping with aragwadadhikasaya karnadhoopana with gugguluvarthi Madhupramarjana and pratimarshanasya with anutaila 5 drops in each nostril will be done twice daily From 7th day onwards karnapoorana with nirgundyadithaila 2ml on both ears as mentioned in classics will be done for a period of 7 days Internally Aragwadadhi kasaya 50 ml twice daily before food and Aragwadadhi tablet 1 tablet twice daily with kashaya is given during the treatment period |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
Patients of age 18 to 50 years
Satisfying the diagnostic criteria
Either sex
Patients fit for karnapoorana
|
|
ExclusionCriteria |
Details |
age not within agelimit of 18 to 50 years
Patient suffering from any systemic diseases and receiving medication
Patient contraindicated for karnapoorana
Other types of ear infection apart from otomycosis
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Fungalmass culture of ear swab
Aural endoscopic pictures |
Fungalmass culture of ear swab will be done before recruitment of patient for the study and after 5 th day of the study
Aural endoscopic pictures after 5th day and 15 the day of study |
|
Secondary Outcome
|
Outcome |
TimePoints |
VAS scale for pruritis and ear ache Grading of ear blokage |
15th day |
|
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/ Phase 3 |
Date of First Enrollment (India)
|
10/09/2019 |
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="10" 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
|
RATIONALE Otomycosis also known as
fungal otitis externa has typically been described as fungal infection of the
external auditory canal. The prevalence of otomycosis has been reported to be
as low as 9% in cases of otitis externa and as high as 30.4% in patients presenting
with symptoms of otitis or inflammatory conditions of the ear. Moreover it
usually occurs most frequently in adults, and less in children. The most common
fungal agents causing otomycosis are Aspergillusniger (80% of case) and Candida
albicans second common. Several factors have been reported predisposing
otomycosis which include; bacterial infections, use of hearing aid or a hearing
prosthesis, self inflicted trauma, swimming in contaminated pools, broad
spectrum antibiotic therapy, steroids and cytostatic medication, neoplasia and
immune disorders .
OBJECTIVE:-The objective of this study is
to test the effectiveness of classical ayurvedic treatment protocol of
putikarna along with Nirgundyadithailakarnapoorana in otomycosis. STUDY DESIGN: Pre
and post test study of 30 patients who are fulfilling the inclusion criteria
will be selected for the present clinical study. Design of the study
After kayasodhana, for first five
days ear mopping with aragwadadhikasaya, karnadhoopana with gugguluvarthi
.Madhupramarjana and pratimarshanasya with anutailawill be done twice daily. On 6th day post fungal culture will be done. If the culture report is negative from 7th day onwards karnapoorana with nirgundyadithaila as
mentioned in classics will be done for a period of 7 days.
Aragwadadhikashaya and tablet will
be administered internally during the treatment course.
Follow-up - After
completion of the treatment the patients will be advised to report to Salakya
OPD once in a month for a period of three months to assess the sustained effect
of treatment.
EXPECTED
COST – 30000 to
40000 INR Statistical analysis will be done using paired t test |