| CTRI Number |
CTRI/2023/04/051372 [Registered on: 06/04/2023] Trial Registered Prospectively |
| Last Modified On: |
22/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Ayurveda management of Otomycosis with the help of Manjishthadi Ghanavati with and without Lakshadi Karnadhoopana (Ear fumigation) |
|
Scientific Title of Study
|
Efficacy of Manjishthadi Ghanavati (orally) with and without Lakshadi Karnadhoopana in the management of Otomycosis- An Open Labelled Randomized Comparative Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Kumawat |
| Designation |
MS Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
4th floor, Department of Shalakya Tantra, I.T.R.A., Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
8989531068 |
| Fax |
|
| Email |
drpriyankak99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajshree Unadkat |
| Designation |
Reader at I.T.R.A. |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
4th floor, Department of Shalakya Tantra, I.T.R.A., Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9427242598 |
| Fax |
|
| Email |
drrajshreeunadkat@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajshree Unadkat |
| Designation |
Reader at I.T.R.A. |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
4th floor, Department of Shalakya Tantra, I.T.R.A., Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9427242598 |
| Fax |
|
| Email |
drrajshreeunadkat@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda, Jamnagar |
|
|
Primary Sponsor
|
| Name |
I.T.R.A., Jamnagar |
| Address |
I.T.R.A., Opposite Group B division Police Station Gurudwara Road, Jamnagar, Gujarat, India 361008 |
| 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 |
| Priyanka Kumawat |
Institute of Teaching and Research in Ayurveda |
O.P.D. no. 4, Shalakya Tantra Department,I.T.R.A., opposite group b division police station, gurudwara road, Jamnagar
Jamnagar
GUJARAT |
8989531068
drpriyankak99@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
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H619||Disorder of external ear, unspecified. Ayurveda Condition: KARNA-KANDU, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Manjishthadi Ghanavati , Reference: Sharangdhara Samhita madhyama khanda 2/136, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - | | 2 | Intervention Arm | Procedure | - | karNadhUpanam, करà¥à¤£à¤§à¥‚पनमॠ| (Procedure Reference: Sushruta uttartantra 22/56, Procedure details: Purva Karma:
• Firstly, ear will be cleaned with suction or dry mopping in case of excessive discharge in the
ear canal.
• The patient will be asked to seat comfortably on a chair, in a place having sufficient light and
devoid of dust.
➢ Pradhana Karma:
• The patient will be asked to relax completely on the chair and fumes are passed to the ear.
Dhoopana yantra tip will be used to cover the ear for the passage of Dhuma into the ear canal.
This Dhoopana will be given for 5 to)
(1) Medicine Name: Lakshadi choorna, Reference: Anubhuta, Route: Otic, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Duration: 30 Days | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Manjishthadi Ghanavati , Reference: Sharangdhara Samhita madhyama khanda 2/136, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
clinical maifestations like pain, itching,, discharge, aural bloackage, deafness, tinnitus, fungal hyphae on examination, inflammation and ulcer in EAC |
|
| ExclusionCriteria |
| Details |
Patients having perforated tympanic membrane, Patients having attico-antral type of CSOM, Patients suffering from any chronic debilitating disease like Ca, Koch’s, Diabetes, HIV etc.
will be excluded from study.
DRUGS |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in objective and subjective criteria of Otomycosis |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in subjective and objective criteria of Otomycosis |
1-2 months |
|
|
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)
|
01/05/2023 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
thi trial is randomized clinical trial to evaluate the efficacy of Manjishtahdi Ghanavati (orally) with and without Lakshadi Karnadhoopana in management of Otomycosis. participants who will be clinically diagnosed and confirmed cases
of Otomycosis enlisted in inclusion criteria will be enrolled as two group with minimum 30 patients. In Group A,
they will be given Manjishthadi Ghanavati, 2 Vati (Each Vati 500 mg) thrice per day orally with luke warm water
after meal and Lakshadi Karnadhoopana locally for 300 Matra (approx.2- 3mins.) at morning for 30 days will be
given. In Group B, only Manjishthadi Ghanavati, 2 Vati (Each Vati 500 mg) thrice per day orally with luke warm
water after meal will be given. Follow-up: Follow up will be for one month duration at interval of 15 days. |