CTRI Number |
CTRI/2022/09/045405 [Registered on: 12/09/2022] Trial Registered Prospectively |
Last Modified On: |
08/09/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Vidanga arka in fungal infection of ear |
Scientific Title of Study
|
"A Randomized open labelled controlled clinical study to evaluate the efficacy of VIDANGA ARKA in the management of KARNASHOOLA 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 Savitri B Saunshimath |
Designation |
PG Scholar |
Affiliation |
Sri Sri College of Ayurvedic Science and Research |
Address |
Room number 305 Department of PG Studies in Shalakyatantra Sri Sri College of Ayurvedic Science and Research Hospital 21st KM Kanakapura main road Udayapura post Bengaluru 560082 Bangalore KARNATAKA
Bangalore KARNATAKA 560082 India |
Phone |
7204460302 |
Fax |
|
Email |
savitrisaunshimath9@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Naveen B S |
Designation |
Professor and HOD |
Affiliation |
Sri Sri College of Ayurvedic Science and Research |
Address |
room number 305
department of PG studies in Shalakyatantra
Sri Sri College of Ayurvedic Science and Research 21st KM, Kanakapura Road, Udayapura Post Banglore-560082
Bangalore KARNATAKA 560082 India |
Phone |
9844991405 |
Fax |
|
Email |
navs009@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Naveen B S |
Designation |
Professor and HOD |
Affiliation |
Sri Sri College of Ayurvedic Science and Research |
Address |
room number 305 department of PG studies in Shalakyatantra
Sri Sri College of Ayurvedic Science and Research 21st KM, Kanakapura Road, Udayapura Post Banglore-560082
Bangalore KARNATAKA 560082 India |
Phone |
9844991405 |
Fax |
|
Email |
navs009@gmail.com |
|
Source of Monetary or Material Support
|
sri sri college of ayurvedic science and research hospital |
|
Primary Sponsor
|
Name |
Dr Savitri B Saunshimath |
Address |
Sri Sri College of Ayurvedic Science and Research 21st KM, Kanakapura Road, Udayapura Post Banglore-560082 |
Type of Sponsor |
Other [others (self)] |
|
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 SAVITRI B SAUNSHIMATH |
SRI SRI COLLEGE OF AYURVEDA SCIENCE AND RESEARCH HOSPITAL |
Room number 305 Department of PG Studies in Shalakyatantra
Sri Sri College of Ayurvedic Science and Research Hospital
21st KM
Kanakapura main road
Udayapura post
Bengaluru 560082 Bangalore KARNATAKA |
07204460302
savitrisaunshimath9@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Sri Sri Institutional Ethical Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:H618||Other specified disorders of external ear. Ayurveda Condition: KARNASULAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: madhu , Reference: sushruta samhita, Route: Topical, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 1(drops), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -ear mopping before treatment | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: vidanga arka, Reference: arka prakasha, Route: Topical, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 1(drops), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -ear mopping before treatment |
|
|
Inclusion Criteria
|
Age From |
21.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. Subjects fulfilling the diagnostic criteria.
2. Subjects within the age of 21 to 60 years irrespective of gender, occupation, religion, socio- economic status and duration of illness.
3. Subjects willing to sign the informed consent.
|
|
ExclusionCriteria |
Details |
1. Subjects having perforated tympanic membrane.
2. Subjects with other aural pathologies (external, middle and inner ear pathologies)
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
changes in the following symptoms will be documented
1. karnashoola
2. karnakandu
3. karnasrava
4. karnapratinaha
|
1.0th day - Before treatment
2.7th day - After treatment
3.14th day - Follow up 1
4.21st day - Follow up 2
5.28th day – Follow up 3
|
|
Secondary Outcome
|
Outcome |
TimePoints |
fungal mass will be assessed using aural endoscopy |
1.0th day - Before treatment
2.7th day - After treatment
3.14th day - Follow up 1
4.21st day - Follow up 2
5.28th day – Follow up 3
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
|
15/09/2022 |
Date of Study Completion (India) |
20/06/2023 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
In this comparative clinical study, Vidanga Arka is taken as the trial drug and Madhu is taken as the control drug. Arka preparations are not only potent, they are also sterile, and have a longer shelf life. The mode of administration of drugs as ear drops is simple and cost effective in the management of Otomycosis. Therefore, in this present study, an effort has been made to evaluate and compare the efficacies of Vidanga Arka and Madhu in the management of Karnashoola w.s.r. to Otomycosis. |