| CTRI Number |
CTRI/2026/01/100153 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
28/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study to compare two Ayurvedic oil therapies for improving hearing in Sensorineural Hearing Loss. |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Trial to Evaluate the Efficacy of Nasya and Karnapoorana with Karpasasthyadi taila and Ksheerabala taila along with Ashwagandhadya ghritapana in Vataja badhirya 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 |
DrNimisha K |
| Designation |
Pg scholar,Department of shalakya tantra |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room number 314, department of shalakya tantra, academic block,National Institute of Ayurveda,Jorawar singh gate,Amer road
Jaipur
RAJASTHAN
302002
India |
| Phone |
9961730118 |
| Fax |
|
| Email |
nimishakarimpil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Sharma |
| Designation |
Proffessor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room number 312 Department of shalakya tantra,Academic block,National Institute of Ayurveda,Jorawar singh gate,Amer road.
Jaipur
RAJASTHAN
302002
India |
| Phone |
8955688129 |
| Fax |
|
| Email |
appu07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrNimisha K |
| Designation |
PG scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room number 314, department of shalakya, academic block,National Institute of Ayurveda,Jorawar Singh Gate,Amer road
Jaipur
RAJASTHAN
302002
India |
| Phone |
9961730118 |
| Fax |
|
| Email |
nimishakarimpil@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jorawar singh gate,Amer road,Jaipur 302002, Rajasthan,India |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Jorawar singh gate,Amer road ,Jaipur 302002,Rajasthan, India |
| 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 Nimisha K |
National Institute of Ayurveda |
OPD number 13 ENT OPD of Shalakya tantra,National Institute Of Ayurveda,Jorawar Singh Gate,Amer road,Jaipur,Rajasthan
Jaipur
RAJASTHAN |
9961730118
nimishakarimpil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee National Institute of Ayurveda |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H905||Unspecified sensorineural hearingloss. Ayurveda Condition: BADHIRYAM (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtanga hrudayam, Procedure details: In this procedure neck and face will be gently massaged with Dashamoola taila & then hot fomentation will be advised followed by 8 drops of Karpasasthyadi taila will be dropped in nostrils & the patient will be asked to spit the medicine which comes to the throat followed by dhoomapana with Haridra varti and saindhav jala Kavala.)
(1) Medicine Name: Karpasasthyadi taila, Reference: Sahasrayogam,taila prakarana,AFI Part-1,8:6,page no-372, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 30 Days | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtanga hrudayam, Procedure details: In this procedure neck and face will be gently massaged with Dashamoola taila & then hot fomentation will be advised followed by 8 drops Ksheerabala taila will be dropped in nostrils & the patient will be asked to spit the medicine which comes to the throat followed by dhoomapana with Haridra varti and saindhav jala Kavala. )
(1) Medicine Name: Ksheerabala taila, Reference: Astangahrudaya,Vataraktacikitsa,Adhyaya 22:45-46,AFI Part 1,8:11,pg no:378-379, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 30 Days | | 3 | Intervention Arm | Procedure | - | Karnapoorana | (Procedure Reference: Sharangadhara samhitha, Procedure details: Purva Karma -Take consent for the procedure and evaluate patient safety. Patient is advised to lie down on a table in right or left lateral position. The area around the ear is massaged with lukewarm oil. First massage the auricle and then massage post auricular area infra auricular area and pre auricular area in the circular motion for 5 min till the oil gets absorbed. Mild hot fomentation around the ear like tapa sweda should be done. Pradhana karma - The medicated liquid (oil) should be gently warmed. The external auditory canal should be straightened by pulling the pinna backward, and upwards. The liquid (oil) should be poured in drops till the ear canal is filled up to the base of the concha. The root of the ear should be gently massaged to potentiate the action of the drug. The medicated oil should be retained in the same position for 100 matras . Paschat karma - The excess oil should be taken out of the external auditory canal by dry cotton. After retaining the medicated oil for the prescribed time, the ear should be cleaned with dry cotton mopping. In bilateral cases, the same procedure should be repeated in the other ear also.)
(1) Medicine Name: Karpasasthyadi taila, Reference: Sahasrayogam,taila prakarana,AFI Part-1,8:6,page no-372, Route: Otic, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 30 Days | | 4 | Comparator Arm | Procedure | - | karNapUraNam, कर्णपूरणम् | (Procedure Reference: Sharangadhara samhitha, Procedure details: Purva Karma -Take consent for the procedure and evaluate patient safety. Patient is advised to lie down on a table in right or left lateral position. The area around the ear is massaged with lukewarm oil. First massage the auricle and then massage post auricular area infra auricular area and pre auricular area in the circular motion for 5 min till the oil gets absorbed. Mild hot fomentation around the ear like tapa sweda should be done. Pradhana karma - The medicated liquid (oil) should be gently warmed. The external auditory canal should be straightened by pulling the pinna backward, and upwards. The liquid (oil) should be poured in drops till the ear canal is filled up to the base of the concha. The root of the ear should be gently massaged to potentiate the action of the drug. The medicated oil should be retained in the same position for 100 matras . Paschat karma - The excess oil should be taken out of the external auditory canal by dry cotton. After retaining the medicated oil for the prescribed time, the ear should be cleaned with dry cotton mopping. In bilateral cases, the same procedure should be repeated in the other ear also)
(1) Medicine Name: Ksheerabala taila, Reference: Astangahrudaya,Vataraktacikitsa,Adhyaya 22:45-46,AFI Part 1,8:11,pg no:378-379), Route: Otic, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 30 Days | | 5 | Intervention Arm | Drug | Classical | | (1) Medicine Name: ASHWAGANDHADYA GHRITA, Reference: Bhaishajya ratnavali,vatavyadhi rogadhikara 26/214, Route: Oral, Dosage Form: Ghrita, Dose: 20(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: -Dose can be vary as per agni bala from 10 to 20 gram. | | 6 | Comparator Arm | Drug | Classical | | (1) Medicine Name: ASHWAGANDHADYA GHRITA, Reference: Bhaishajya ratnavali,vatavyadhi rogadhikara 26/214, Route: Oral, Dosage Form: Ghrita, Dose: 20(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: - |
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing to participate in the study
2.Patients having specific signs and symptoms of Badhirya (SNHL) as per Ayurvedic and modern parameters will be registered
Ayurvedic symptom : Hearing difficulty without discharge ,with or without associated with karnanada and bhrama,
Modern:Hearing loss with or without tinnitus and vertigo.
3.Pure tone audiometry findings(sensorineural pattern),and supportive tuning fork tests(Rinne positive,Weber lateralised to better ear)
4.Patients having mild to moderate hearing loss(26-55db) in the better ear as per WHO grading.
5.Patients in the age group of 40-70 years |
|
| ExclusionCriteria |
| Details |
1.Patients having any congenital hearing loss.
2.Individuals of SNHL secondary to other diseases like carcinoma, Meniere’s disease, otosclerosis.
3.Uncontrolled diabetes mellitus and hypertension.
4.Perforated TM.
5.Pregnant women.
6.Psychogenic hearing loss.
7.History of intake of ototoxic drugs.
8.Infectious diseases such as measles, meningitis, or any TORCH infection.
9.Hyperlipidaemia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in difficulty in hearing of the patient assessed by using pure tone audiometry(PTA) and HHIA or HHIE. |
Changes in difficulty in hearing of the patient assessed by using pure tone audiometry(PTA) and HHIA or HHIE at baseline,Day 30 and 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Changes in tinnitus(karnanada) and vertigo(bhrama)using grading scales. |
baseline to Day 30,Day 45. |
|
|
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 |
|
Date of First Enrollment (India)
|
01/05/2026 |
| 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 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
|
Sensorineural hearing loss is a common condition that significantly affects communication and quality of life, and effective curative treatments are limited. Ayurveda describes a similar condition as Vataja Badhirya, for which procedures like Nasya, Karnapoorana, and Rasayana therapy are recommended. This study is a randomized, open-label, comparative clinical trial designed to evaluate and compare the effectiveness of two Ayurvedic treatment protocols in patients with mild to moderate sensorineural hearing loss. Sixty eligible participants will be randomly allocated into two groups. One group will receive Nasya and Karnapoorana with Karpasasthyadi Taila along with Ashwagandhadya Ghritapana, while the other group will receive Nasya and Karnapoorana with Panchavalkala Taila along with Ashwagandhadya Ghritapana. The treatment will be administered for 30 days, with a follow-up period of 15 days. The primary outcome will be assessed by changes in hearing thresholds measured using pure tone audiometry. Secondary outcomes will include improvement in tinnitus, vertigo, and quality of life assessed using appropriate grading scales and questionnaires. The study aims to generate clinical evidence regarding the role of Ayurvedic therapies in the management of sensorineural hearing loss. |