| CTRI Number |
CTRI/2024/11/076515 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
30/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study the effect of Dashmoola Taila Karnapoorana with Sarivadi Vati oral administration in Karnabadhirya |
|
Scientific Title of Study
|
Open randomised controlled clinical study to evaluate the effect of Dashmoola Taila Karnapoorana with Sarivadi Vati oral administration in Karnabadhirya w.s.r to Sensorineural Hearing loss |
| 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 Meera Meghdoot Dhage |
| 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
Shalakya tantra department,
OPD no.5, Kodoli
Dist.Kolhapur, Maharashtra
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9403303800 |
| Fax |
|
| Email |
meeradhage11@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
|
| Daily OPD patients from Yashwant Ayurvedic Medical
College PGT and RC Kodoli , Dist.Kolhapur, Maharashtra, India.
Pin code 416114 |
|
|
Primary Sponsor
|
| Name |
Dr Meera Meghdoot Dhage |
| Address |
Yashwant Ayurvedic College Kodoli Kolhapur, Tal Panhala, District - Kolhapur, Maharashtra, India. Pin code 416114 |
| 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 |
| Dr Meera Meghdoot Dhage |
Yashwant Dharamartha Rugnalaya,Kodoli. |
Yashwant Ayurveda Medical College PGT and RC Kodoli OPD no.5 Shalakya Tantra Department.
Kolhapur
MAHARASHTRA |
9403303800
meeradhage11@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:H833||Noise effects on inner ear. Ayurveda Condition: BADHIRYAMÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | karNapUraNam, करà¥à¤£à¤ªà¥‚रणमॠ| (Procedure Reference: Sharandhar Samhita Uttartantra 11/28, Procedure details: Dashamool Taila karnapuran 10 drops in affected ear for 100 matra (2 mins) once a day)
(1) Medicine Name: Dashamool Taila , Reference: Chakradatta karnarogchikitsaprakarnam 29, Route: Otic, Dosage Form: Taila, Dose: 10(drops), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm | Procedure | - | karNapUraNam, करà¥à¤£à¤ªà¥‚रणमॠ| (Procedure Reference: Sharandhar Samhita Uttartantra 11/28, Procedure details: Bilwa taila karnapuran 10 drops in affected ear for 100 matra (2 mins) once a day)
(1) Medicine Name: Bilwa taila , Reference: Chakradatta karnarogchikitsaprakarnam 29, Route: Otic, Dosage Form: Taila, Dose: 10(drops), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having signs & symptoms of Karnabadhirya & Sensorineural hearing loss Degree of hearing loss less than 80 dB SNHL Unilateral or bilateral deafness Intact tympanic membrane |
|
| ExclusionCriteria |
| Details |
conductive deafness mixed hearing loss middle ear pathology inner ear pathology |
|
|
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 |
| Increase in hearing capacity |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in ringing in ear, Increase in hearing capacity |
18 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/11/2024 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is open randomised controlled clinical trial to evaluate the effect of Dashmoola Taila Karnapoorana with Sarivadi Vati oral administration in Karnabadhirya w.s.r to Sensorineural Hearing loss. 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 |