| CTRI Number |
CTRI/2025/04/085228 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An ayurvedic management of sensory neural hearing loss |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the effect of panchavalkala taila karnapoorana and dashamoola taila karnapoorana in the management of badhirya with special reference to sensory neural 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 Sukritha Y N |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College Bengaluru |
| Address |
Department of pg studies in shalakya tantra, Government ayurveda
medical college, Dhanvantari road, Majestic, Bengaluru Karnataka
560009
Bangalore
KARNATAKA
560009
Bangalore
KARNATAKA
560009
India |
| Phone |
7676020532 |
| Fax |
|
| Email |
ynsukrutha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syed Munawar Pasha |
| Designation |
Professor |
| Affiliation |
Government Ayurveda Medical College Bengaluru |
| Address |
Department of pg studies in shalakya tantra, Government ayurveda
medical college, Dhanvantari road, Majestic, Bengaluru Karnataka
560009
Bangalore
KARNATAKA
560009
Bangalore
KARNATAKA
560009
India |
| Phone |
9886593932 |
| Fax |
|
| Email |
smpasha78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sukritha Y N |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College |
| Address |
Department of pg studies in shalakya tantra, Government ayurveda
medical college, Dhanvantari road, Majestic, Bengaluru Karnataka
560009
Bangalore
KARNATAKA
560009
Bangalore
KARNATAKA
560009
India |
| Phone |
7676020532 |
| Fax |
|
| Email |
ynsukrutha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Sukritha Y N, Government Ayurveda Medical College, Dhanwantari road,Bengaluru,560009, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Sukritha Y N |
| Address |
Yelechagahalli village and post, Holenarasipura talluku, Hassan District,573211 |
| 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 Sukritha Y N |
Government Ayurveda Medical College Bengaluru |
Shalakya Tantra OPD Room No 11, Government Ayurveda Medical College, Dhanwantari road, Majestic, Bengaluru,560009, Karnataka
Bangalore
KARNATAKA |
7676020532
ynsukrutha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government Ayurveda Medical College Bengaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H904||Sensorineural hearing loss, unilateral with unrestricted hearing on the contralateral side. Ayurveda Condition: BADHIRYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dashamoola taila , Reference: Chakradatta samhita by P V Sharma 56th chapter 27th shloka , Route: Otic, Dosage Form: Taila, Dose: 140(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: 2 sitting of karnapoorana for 7 days with a gap of 7 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Panchavalkala taila , Reference: Chikitsasara sangraha of vangasena second edition page number 865,shloka number 86, Route: Otic, Dosage Form: Taila, Dose: 140(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: 2 sitting of karnapoorana for 7 days with a gap of 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with mild to moderate sensorineural hearing loss.
2.Age groups between 30-70 years will be included in the study.
3.Patients with intact tympanic membrane. |
|
| ExclusionCriteria |
| Details |
1.Congenital sensorineural hearing loss
2.Patients with conducting hearing loss
3.Patients with Tinnitus, Vertigo, Otorrhea
4.Perforated tympanic membrane
5.Patients with other systemic diseases
6.Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pure Tone Audiometry |
51 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hearing Loss |
51 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
02/05/2025 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Badhirya is one among karnarogas according to Acharya Sushrutha and Vagbhata . It is defined as impairment in hearing ability. According to Acharya Vagbhata when vitiated kaphanubandha vata dosha obstructing the shabdavaha srotas it results in hearing difficulty called Badhirya1. Most of the classical symptoms of Badhirya have similar symptoms of Sensory Neural Hearing Loss.Sensory Neural Hearing Loss is a disease of sensory type of cochlea and Vlll cranial nerve and it’s neural type of central connections. Any damage to the inner ear, either of the Auditory nerve or Hair cells in the cochlea results in sensory neural hearing loss. Hearing is an important medium, which keeps one connected to other and with surroundings. 466 million (~6.1%) of the world’s population are estimated to be living with hearing loss. It is estimated that by 2050 over 900 million people or one in every 10 people will have disabling hearing loss. 1.1 billion young people (12-35 years) are at risk of hearing loss. According to W.H.O “A person who is not able to hear and someone with normal hearing –hearing thresholds of 25dB or better in both ears –is said to have hearing loss”. The ear normally perceives sounds in the range of 20 to 20,000 vibrations/Hz per second. Modern science has many ways of intervention in managing Sensory neural hearing loss, includes medicines, Hearing aids and Cochlear implants.Despite significant advance, there are still some challenges and limitations.Hearing aids are expensive, users are at high risk for ear canal skin irritation,earwax build-up and not providing comfort to patients. Hence an alternative treatment which is safe, devoid of complications, cost effective is the need of the hour. The treatment that are told in classics are Ghrutapana, Snehana, Swedana, karnapurana.Snehana is the principle line of treatment for controlling Vata dosha. Karnapoorana is a type of Bahya snehana, thus it is the best treatment for Vata nigraha. Panchavalkala taila karnapurana mentioned in Vangasena Samhitha2 and Dashamoola Taila karnapurana mentioned in Chakradatta4 are indicated in Badhirya. Considering all these facts, this work “A Comaparative Clinical Study To Evaluate The Efficacy Of Dashamoola Taila and Panchavalkala Taila Karnapoorna in Management of Badhirya with special reference to Sensory Neural Hearing Loss” has been taken up. |