Development of EnhAnced electRonic Aural Instillation Device (EAR-AID)- A comprehensive instrument for Karnapurana (topical oil pooling in ears)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: Two years
次要结局
- 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)
研究者
Krishna Kumar V
National Ayurveda Research Institute fort Panchakrma , Cheruthuruthy