| CTRI Number |
CTRI/2025/07/091119 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Development of an instrument for Ayurvedic Ear Oil Therapy for testing its safety and efficacy in healthy volunteers |
|
Scientific Title of Study
|
Development of EnhAnced electRonic Aural Instillation Device (EAR-AID)- A comprehensive instrument for Karnapurana (topical oil pooling in ears) |
| Trial Acronym |
EAR-AID |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishna Kumar V |
| Designation |
Reserach Officer(Ayurveda) |
| Affiliation |
National Ayurveda Research Institute fort Panchakrma , Cheruthuruthy |
| Address |
Department of Ayurveda, Hospital Block, OPD.NO-4
National Ayurveda Research Institute for Panchakrma , Cheruthuruthy-679531, Thrissur, Kerala
Thrissur
KERALA
679531
India |
| Phone |
07306892140 |
| Fax |
|
| Email |
drkkempran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Krishna Kumar V |
| Designation |
Reserach Officer(Ayurveda) |
| Affiliation |
National Ayurveda Research Institute fort Panchakrma , Cheruthuruthy |
| Address |
Department of Ayurveda, Hospital Block, OPD.No.4
National Ayurveda Research Institute for Panchakrma , Cheruthuruthy-679531, Thrissur, Kerala
KERALA
679531
India |
| Phone |
07306892140 |
| Fax |
|
| Email |
drkkempran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Krishna Kumar V |
| Designation |
Reserach Officer(Ayurveda) |
| Affiliation |
National Ayurveda Research Institute fort Panchakrma , Cheruthuruthy |
| Address |
Department of Ayurveda, Hospital Block, OPD.No-4
National Ayurveda Research Institute for Panchakrma , Cheruthuruthy-679531, Thrissur, Kerala
KERALA
679531
India |
| Phone |
07306892140 |
| Fax |
|
| Email |
drkkempran@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
61-65, opp. D’ Block, D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi 110058 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Krishna Kumar V |
National Ayurveda Reserach Institute for Panchakarma |
Department of Ayurveda, Hospital Block, OPD.NO-4
Cheruthuruthy-679531, Thrissur, Kerala
Thrissur
KERALA |
07306892140
drkkempran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institututional Ethics Committee, National Ayurveda Reserach Institute for Panchakarma, Cheruthuruthy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteer |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: A.H.SU.22/32, Procedure details: Pre-requisite procedure includes temporal region massage with processed gingelly oil (murchitatila taila) )
(1) Medicine Name: murchitatila taila, Reference: API-Part-II, Volume-1, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | karNapUraNam, कर्णपूरणम् Pradhan Karma | (Procedure Reference: A.H.SU.22/32, Procedure details: Main procedure is instillation of 5 ml of Murchita tila taila in each external auditory canal for 15-20 min in morning. )
(1) Medicine Name: Murchita tila taila , Reference: API-Part-II, Volume-1, Route: Otic, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 7 Days | | 3 | Comparator Arm | Procedure | - | not applicable | (Procedure Reference: A.H.SU. 22/32, Procedure details: Post-procedure includes massaging of base of ears for 100 matra (100 seconds))
| | 4 | Comparator Arm | Procedure | - | karNasvedanam, कर्णस्वेदनम् | (Procedure Reference: A.H.SU.22/32, Procedure details: Swedana is done after Abhyanga)
| | 5 | Comparator Arm | Procedure | - | pramArjana-karma, प्रमार्जन-कर्म | (Procedure Reference: A.H.SU.22/32, Procedure details: After 15-20 min of instillation, oil from the ear canal will be wiped with dry cotton. )
| | 6 | Intervention Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: A.H.SU.22/32, Procedure details: Pre-requisite procedure includes temporal region massage with processed gingelly oil (murchitatila taila) )
| | 7 | Intervention Arm | Procedure | - | karNasvedanam, कर्णस्वेदनम् | (Procedure Reference: A.H.SU.22/32, Procedure details: Swedana is done after Abhyanga)
| | 8 | Intervention Arm | Procedure | - | karNapUraNam, कर्णपूरणम् Pradhan Karma | (Procedure Reference: A.H.SU.22/32, Procedure details: Main procedure is instillation of 5 ml of Murchita tila taila in each external auditory canal for 15-20 min in morning using the instrument EAR-AID)
| | 9 | Intervention Arm | Procedure | - | not applicable | (Procedure Reference: A.H.SU.22/32, Procedure details: Post-procedure includes massaging of base of ears for 100 matra (100 seconds))
| | 10 | Intervention Arm | Procedure | - | pramArjana-karma, प्रमार्जन-कर्म | (Procedure Reference: A.H.SU.22/32, Procedure details: After 15-20 min of instillation, oil from the ear canal will be removed using the instrument EAR-AID)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Willing to participate and give written informed consent
Physically independent, ambulatory volunteers
BMI of 17.5 to 30.5 kg/m2
Healthy status would be assessed by the absence of evidence of any active or chronic disease following a detailed medical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology, psychological assessment and urinalysis and also assessment on the basis of CCRAS Health Assessment Scale
|
|
| ExclusionCriteria |
| Details |
Any condition which is contraindicated for Karnapurana like abnormal middle ear.
Current hearing aid user for more than 3 months
Uncontrolled hypertension (Systolic BP greater than 140mmHg and or Diastolic BP greater than 90mmHg)
Uncontrolled Diabetes (HbA1c greater than 8 percentage).
History of Hypersensitivity to the trial drug or any of its ingredients.
Continuing addiction to smoking and usage of tobacco in any form
Individuals simultaneously or previously (within 30 days prior to investigation start) participate in a clinical investigation using experimental drugs or devices.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Successful design and functional development of the EAR-AID device that enables automated delivery and removal of medicated oils in accordance with the therapeutic requirements of Karnapurana therapy.
|
Two years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety assessed through incidence of adverse events or device-related complications encountered during its use |
Two years |
| Efficacy: Accuracy of medicated oil delivery (volume, rate, and temperature) as per therapeutic protocol. |
Two years |
| Usability assessed through Standardized usability questionnaires are critical tools for assessing how users perceive the usability of a product in the following aspects: Ease of setup, comfort during use, time efficiency, learnability, error rate, user satisfaction, task completion success rate, need for assistance, and confidence in using the device. |
Two years |
| Reliability & validity: Demonstrated consistent and stable performance of the EAR-AID device across multiple sessions (e.g., 10–15 consecutive uses), with no operational failures, critical errors, throughout the evaluation period, assessed through clinical study by comparing with classical Karnapurana (existing gold standard method). |
Two years |
| Feasibility: Successful integration of the EAR-AID device into clinical or therapeutic settings without requiring significant modifications to existing workflows, along with demonstrated acceptability and positive reception by end-users, as assessed through structured feedback and qualitative interviews. |
Two years |
|
|
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 3 |
|
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="0"
Months="10"
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
|
Ayurveda has a specialty branch known as Shalakya
Tantra, which deals with diseases of the eyes, ears, nose, and throat.
Karnapurana is a treatment modality in this branch, wherein medicated oil is
instilled into the ear canal for a stipulated duration and removed. It has many
applications in various ear disorders like deafness, tinnitus, vertigo, and
other systemic diseases like hemiplegia and Bell’s palsy.
Presently, Karnapurana is performed
manually by a trained Panchakarma therapist. This method has certain
limitations. The primary limitation pertains to the installation of oil.
Presently, it is done with a gokarna/spoon. Hygiene cannot be adequately
maintained, and there is more waste of medicine in this method. The second
limitation is related to the removal of oil after the procedure. At present, it
is done with a cotton bud. However, if it is not done correctly, the oil may be
retained in the ear canal, which may harbor fungal infections in the ear canal.
Due to these limitations, there is a scope
for a novel instrument to perform the karnapurana. This instrument should
function in such a way that there is the provision of regulation of the oil
temperature, and oil is instilled hygienically. Also, there should be a
mechanism to remove the oil after the procedure.
We are using
biocompatible silicone tubing for
administering medication into the ear and removing the medication. These tubes
can be sterilized for reuse or
discarded after a single use. They are recyclable, highly cost-effective, and
designed with patient safety in mind.
To prevent
contamination, we are using peristaltic pumps for administering medication. The
medication flows through biocompatible silicone tubing, ensuring it does not
come into contact with the device itself. As a result, the device will not harbor harmful microorganisms and
will effectively prevent any bacterial
or fungal growth, ensuring a safe and sterile application. This setup
guarantees non-toxicity and
maintains the integrity of the medication. |