| CTRI Number |
CTRI/2025/03/083097 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Bilwadi Taila Karnapurana (filling of medicated oil in ear) and Sarivadi Vati orally with and without Shadabindu Taila Nasya (instillation of medicated oil in nostrils) in the management of Badhirya (Sensory Neural Hearing Loss) |
|
Scientific Title of Study
|
Efficacy of Bilwadi Taila Karnapurana and Sarivadi Vati with and without Shadabindu Taila Nasya in the management of Badhirya (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 |
Radhika |
| Designation |
M.S. Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar, Gujrat |
| Address |
4th Floor, Department of Shalakya Tantra, institute building, Institute of Teaching and Research in Ayurveda, Jamnagar Gujrat 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
8427283823 |
| Fax |
|
| Email |
radhikathakur842@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr D B Vaghela |
| Designation |
Professor, HOD |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar, Gujrat |
| Address |
4th Floor, Department of Shalakya Tantra, institute building, Institute of Teaching and Research in Ayurveda, Jamnagar Gujrat 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9825407899 |
| Fax |
|
| Email |
drvaghela@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Radika |
| Designation |
M.S. Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
4th Floor, Department of Shalakya Tantra, institute building, Institiute of Teaching and Research in Ayurveda, Jamnagar, Gujrat 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
8427283823 |
| Fax |
|
| Email |
radhikathakur842@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda, opposite B division police station, gurudwara road Jamnagar Gujrat 361008 |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
Institue of Teaching and Research in Ayurveda, opp. to B division police station, Jamnagar Gujrat 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 |
| Radhika |
INSTITUTE OF TEACHING AND RESEARCH IN AYURVEDA, JAMNAGAR |
OPD NO A3 ENT OPD OF SHALAKYA TANTRA INSTITUTE OF TEACHING AND RESEARCH IN AYURVEDA OPPOSITE B DIVISION POLICE STATION GURUDVARA ROAD JAMNAGAR GUJARAT 361008
Jamnagar
GUJARAT |
8427283823
radhikathakur842@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Teaching and Research in Ayurveda, Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H838||Other specified diseases of innerear. Ayurveda Condition: BADHIRYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ambikaduttshastri; Ayurvedtatva sandeepika, Sushruta Samhita Uttar Tantra 21/35, Procedure details: The patient will be made to lie in supine position extending his/her arms and legs and head slightly extended up to 45 degrees.
Later tip of the nose will be drawn upward with the help of Vama Pradeshni (left index finger) of physician and with right hand 6-6 drops of the lukewarm Shadabindu Taila will be instilled into both nostrils using dropper.
The patient will lie in supine position for hundred Matra (approx. 2-3 min.).
Massage will be done on forehead scalp and cheek.
Gargles with luke warm water will be done to get mouth and throat cleaned
)
(1) Medicine Name: Shadabindu Taila, Reference: Bhaishajya Ratnavali, Shiro Rogadhikara 65/81-83, Route: Nasal, Dosage Form: Taila, Dose: 12(drops), Frequency: od, Duration: 21 Days | | 2 | Intervention Arm | Procedure | - | karNapUraNam, कर्णपूरणम् | (Procedure Reference: Ambikaduttshastri; Ayurvedtatva sandeepika, Sushruta Samhita Uttar Tantra 21/35, Procedure details: Bilwadi Taila will be gently warmed by keeping in luke warm water. The external auditory canal will be straightened by pulling the pinna backward and upwards.
Bilwadi Taila will be poured drop by drop till the ear canal will be filled up.
The excess oil will be taken out of the external auditory canal by dry cotton. After retaining the Bilwadi Taila for hundred Matra (approx.2-3 min.) the ear will be cleaned with dry cotton mopping.
)
(1) Medicine Name: Bilwadi Taila, Reference: Ambikaduttshastri; Ayurvedtatva sandeepika, Sushruta Samhita Uttar Tantra 21/35, Route: Otic, Dosage Form: Taila, Dose: 26(drops), Frequency: od, Duration: 21 Days | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sarivadi Vati, Reference: Bhaisajya Ratnavali Karna Rogadhikara 62/72-77, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, 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 |
1.Patient between the age of Eighteen to Sixty year. 2.Degree of Hearing Loss (Between 25dB to 90dB Sensory Neural Hearing Loss) |
|
| ExclusionCriteria |
| Details |
1. Patient below Eighteen years and above Sixty years of age.
2. Degree of Hearing Loss greater than 90dB.
3. Conductive hearing loss 4. Mixed hearing loss
5. Inner ear pathology like Acoustic Neuroma, Menieres disease. 6. Genetic Sensory Neural Hearing Loss 7. Syphilitic Sensory Neural Hearing Loss 8. Psycogenic hearing loss 9. Systemic diseases: Diabetes, Hypothyroidism, Renal disorders, Autoimmune disorders, Multiple sclerosis. 10. Malignancy 11. Pregnant women 12. Patient taking any systemic drugs which can alter the result of study 13. Patients who need surgical intervention. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of intervention on signs and symptoms of Badhirya (Sensory Neural Hearing Loss) and reduction in the subjective criteria assessed. |
30 days (4 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
01/05/2025 |
| 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="1"
Months="0"
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 trial is randomized clinical trial to evaluate Efficacy of Bilwadi Taila Karnapurana and Sarivadi Vati with and without Shadabindu Taila Nasya in the management of Badhirya (Sensory Neural Hearing Loss). Total 30 patients will be divided into two groups on the basis of computer-based randomization. In the study Bilwadi Taila Karnapurana 24-26 drops in each ear at evening time for 100 matra, Sarivadi Vati orally, 2 Vati (each Vati 250mg) thrice a day with lukewarm water after meal and Shadabindu Taila Nasya (6-6 drops in each nostril) at morning will be done in one group (group-A). In other group (group-B) only Bilwadi Taila Karnapurana and Sarivadi Vati is given without Shadabindu Taila Nasya for 1 month duration. Follow up will be carried out at 15 days interval for one month after completion of therapy. |