None listed
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Timepoint: Two years | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessed through incidence of adverse events or device-related complications encountered during its useTimepoint: Two years;Efficacy: Accuracy of medicated oil delivery (volume, rate, and temperature) as per therapeutic protocol.Timepoint: 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.Timepoint: 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).Timepoint: 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.Timepoint: Two years | — |
Countries
India
Contacts
Public ContactKrishna Kumar V
National Ayurveda Research Institute fort Panchakrma , Cheruthuruthy
Outcome results
None listed