An Open Label Randomized Controlled Clinical Study On The Evaluation Of The Efficacy Of Vachalashunadi Taila Ear Drops In Otomycosis (Kaphaja Karna Roga)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Management of Otomycosis in Ear
研究概览
简要总结
Otomycosis is described as the superficial and diffuse fungal infection of the external auditory canal. It is more commonly found in tropical and subtropical regions. The fungal species that are frequently involved are the Aspergillus niger and *Candida albicans.*The symptoms observed are pruritis, feeling of fullness in the ear canal, pain, discharge from the ears and hearing loss.
In Ayurveda, Karna rogas has been explained by various Acharyas. Avasyaya (exposure to cold environment), Jalakreeda (swimming), Mithya yogena shastrasya (improper instrumentation) and Shira snana (regularly taking head bath) have been described as the Nidanas (causative factors) for the Karna rogas. Acharya Charaka explained four Karna rogas, out of which Kaphaja Karna roga includes symptoms such as Kandu (itching), Vaishrutya (decreased hearing), Shukla shruti (whitish discharge) and Alpa ruk (mild pain). The main line of treatment of Kaphaja Karna roga includes Kaphahara Upakramas such as Teekshna nasya, Teekshna dhooma, Nadisweda, Vamana etc. Sthanika (local) Upakramas include Karna parimarjana, Karna poorana, Karna pichu.
In the Modern science, the treatment of Otomycosis includes local debridement, topical and systemic antifungal medications. Topical antifungal drugs include clotrimazole, nystatin etc. These drugs even though are effective in reducing the signs and symptoms of the disease, most of the cases remain uncured completely and relapsing of the disease is common. Hence, the present research is undertaken to evaluate the effect of Vachalashunadi Tailaear drops and to compare the efficacy with 1% Clotrimazole ear drops in Otomycosis (Kaphaja Karna roga).
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Subjects of any gender irrespective of religion, race, occupation presenting with the signs and symptoms of Otomycosis (Kaphaja Karna roga) described as per Ayurveda and modern science 2.Subjects between the age group of 18 – 70 years 3.Subjects who consent for participation in the study.
排除标准
- •1.Subjects diagnosed with Active Otitis Media, Tympanic Membrane Perforation, CSOM, Otitis externa, Cholesteatoma and previous history of ear surgery 2.Subjects diagnosed with systemic diseases like Tuberculosis, Malignancies, uncontrolled Diabetes Mellitus 3.Subjects who are a known case of Immunocompromised conditions, Fungal diseases elsewhere in the body.
结局指标
主要结局
Management of Otomycosis in Ear
时间窗: 14 days
Negative Potassium Hydroxide Test
时间窗: 14 days
次要结局
- Reduction in the symptoms - Itching, Feeling of fullness in the ear, Earache, Ear Discharge(14 Days)
研究者
Dr Thoppe Sridhar Vayishnavi
JSS Ayurveda Medical College and Hospital
