| CTRI Number |
CTRI/2025/06/089770 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
24/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Viddhakarma with Katu taila Karnapurana is an Ayurvedic measure for improving Hearing ability in Hearing loss |
|
Scientific Title of Study
|
Add on Effect of Viddhakarma along with Katu Taila Karnapurana in Management of Karna Badhirya with special reference to Sensori-neural Hearing loss- A Randomized Controlled Clinical Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BMK/25/PG/SKT/04 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madhu Smita Devi |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahpur Belagavi Karnataka India |
| Address |
Department of Shalakya Tantra OPD no 26
KAHERs Shri BM Kankanwadi Ayurveda Mahavidyalaya Shahpur Belagavi Karnataka India 590003
Belgaum
KARNATAKA
590003
India |
| Phone |
7008790362 |
| Fax |
|
| Email |
madhusmitadevi2012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savita S Angadi |
| Designation |
Professor and HOD |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahpur Belagavi Karnataka India |
| Address |
Department of Shalakya Tantra OPD no 26
KAHERs Shri BM Kankanwadi Ayurveda Mahavidyalaya Shahpur Belagavi Karnataka India 590003
Belgaum
KARNATAKA
590003
India |
| Phone |
7411213286 |
| Fax |
|
| Email |
savitaangadi.kaher@kleayurworld.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Savita S Angadi |
| Designation |
Professor and HOD |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahpur Belagavi Karnataka India |
| Address |
Department of Shalakya Tantra OPD no 26
KAHERs Shri BM Kankanwadi Ayurveda Mahavidyalaya Shahpur Belagavi Karnataka India 590003
Belgaum
KARNATAKA
590003
India |
| Phone |
7411213286 |
| Fax |
|
| Email |
savitaangadi.kaher@kleayurworld.edu.in |
|
|
Source of Monetary or Material Support
|
| Kankayana OPD no 26 KAHERs Shri BM Kankanwadi Ayurveda Mahavidyalaya and Hospital Shahpur Belagavi Karnataka India pin code 590003 |
|
|
Primary Sponsor
|
| Name |
Dr. Madhu Smita Devi |
| Address |
KAHERs Shri BM Kankanwadi Ayurveda Mahavidyalaya, Shahpur, Belagavi, Karnataka, India, 590003 |
| Type of Sponsor |
Other [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 Madhu Smita Devi |
KAHERs Shri BM Kankanwadi Ayurveda Hospital And MRC |
Depertment of shalakyatantra Kankayana OPD No 26 KAHERs Shri BM Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka India Pincode 590003
Belgaum
KARNATAKA |
7008790362
madhusmitadevi2012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe for Research on Human Subjectse |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H80-H83||Diseases of inner ear. Ayurveda Condition: BADHIRYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | vedhana-karma, वेधन-कर्म | (Procedure Reference: Susruth Samhita , Procedure details: Viddhakarma is done in every alternate day for first 8 days along with Katu Taila Karnapurana administrate daily for first 8 days then a gap of 7 days is given again the procedure is repeated)
(1) Medicine Name: Katu Taila, Reference: Bhaisajya Ratnavali, Route: Otic, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 6(drops), Frequency: od, Duration: 4 Weeks | | 2 | Comparator Arm | Procedure | - | karNapUraNam, कर्णपूरणम् | (Procedure Reference: Sushrut Samhita , Procedure details: Katu Taila Karnapurana is done daily for first 8 days then a gap of 7 days is given again the above procedure is repeated)
(1) Medicine Name: Katu Taila , Reference: Bhaisajya Ratnavali, Route: Otic, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 6(drops), Frequency: od, Duration: 4 Weeks |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Having clinical features of sensorial-neural Hearing loss
Hearing loss ranges from mild to moderate |
|
| ExclusionCriteria |
| Details |
Conductive and Mixed Hearing Loss
Diagnosed case of CSOM and TM perforation
Infectious diseases such as Herpes, Mumps, etc
Known case of Aural tumor, polyp, trauma
Uncontrolled Diabetes and Hypertension
History of Ototoxic drugs, anticoagulant therapy
Pregnant ladies and Lactating mothers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Viddhakarma along with Katu Taila Karnapurana improved the hearing ability in Badhirya |
0th day 8th day 24th day 54th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
01/01/2026 |
| 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
|
Hearing loss is the most common deficit; approximately 6.3% of the Indian population is affected. There is no such treatment procedure that can cure the condition; rather, to improve the hearing ability, Ayurvedic managements need to be done. Viddhakarma and Karnapurana are a few managements that can be used in the treatment measures for Karna Badhirya. |