| CTRI Number |
CTRI/2024/11/077306 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Evaluate the effect of Vachalashunadi tail Karnapooran in Karnastrava |
|
Scientific Title of Study
|
Open randomised controlled clinical study to evaluate the effect of vachalashunadi tail Karnapooran in karnastrava |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Punyai Shankar Raut |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC Kodoli |
| Address |
Yashwant Ayurvedic Medical College PGT and RC Kodoli
Shalakyatantra department OPD no-5,Kodoli Dist:Kolhapur, MAHARASHTRA
Yashwant ayurvedic medical college PGT and RC kodoli shalakyatantra departmentOPD no 5,Kodoli, Dist kolhapur Maharashtra
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8378085976 |
| Fax |
|
| Email |
punyairaut@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran Patil |
| Designation |
PG Guide, Associate professor of Shalakyatantra department |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC Kodoli |
| Address |
Yashwant Ayurvedic Medical College PGT and RC Kodoli Shalakyatantra department OPD no-5, Kodoli Dist: Kolhapur, MAHARASHTRA
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7020519271 |
| Fax |
|
| Email |
dr.kp1976@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran Patil |
| Designation |
PG Guide, Associate professor of Shalakyatantra department |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC Kodoli |
| Address |
Yashwant Ayurvedic Medical College PGT and RC Kodoli Shalakyatantra department OPD no-5, Kodoli Dist: Kolhapur, MAHARASHTRA
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7020519271 |
| Fax |
|
| Email |
dr.kp1976@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant ayurvedic College PG and RCT kodoli tal panhala dist kolhapur 417114 |
|
|
Primary Sponsor
|
| Name |
Dr Punyai Shankar Raut |
| Address |
Yashwant Ayurvedic college Kodoli, Kolhapur |
| 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 Punyai Raut |
Yashwant Dharamartha Rugnalaya Kodoli. |
Yashwant Ayurvedic Medical College PGT and RC Kodoli OPD no 5, Shalakyatantra department .
Kolhapur
MAHARASHTRA |
8378085976
punyairaut@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee Yashwant Ayurvedic Medical College PGT and RC Kodoli |
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: KARNA-SRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vacha lasunadi taila , Reference: Sahastrataila yog prakaran , Route: Otic, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 10(drops), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -no(2) Medicine Name: Vachalashunadi taila , Reference: Sahastrataila yog prakaran , Route: Otic, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 10(drops), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -no | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kshar Taila, Reference: Sharangadhar Samgita, Route: Otic, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 10(drops), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: No |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Intact tympanic membrane
Patient having discharge of EAC (Otomycosis,Diffused,Otitis
Externa, Localized Otitis Externa) |
|
| ExclusionCriteria |
| Details |
Patients other than karnastrava will be excluded
Patients below 10 and above 60 years of age group
Patient having systemic disease with complications which can
lead to interference with the study.
[diabetes,hypertension,thyroid] |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in karnastrava |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Decrease in karna kandu, decrease in karna ruja, decrease in karnastrava
decrease in meatal skin colour |
18 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
10/12/2024 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a open randomised controlled clinical study to evaluate the effect of vachalashunadi tail karnapooran in karnastrava. Study will be carried in OPD of Shalakyatantra department of Yashwant Ayurvedic Medical College and Hospital kodoli.The observation would be drawn on the basis of symptoms after treatment given. |