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临床试验/CTRI/2024/08/072419
CTRI/2024/08/072419尚未招募2/3 期

An Open Label Randomized Controlled Clinical Study On The Evaluation Of The Efficacy Of Vachalashunadi Taila Ear Drops In Otomycosis (Kaphaja Karna Roga)

Dr Thoppe Sridhar Vayishnavi2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月26日最近更新:

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 rogasAcharya 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

发起方
Dr Thoppe Sridhar Vayishnavi
申办方类型
Other [(Self) ]
责任方
Principal Investigator
主要研究者

Dr Thoppe Sridhar Vayishnavi

JSS Ayurveda Medical College and Hospital

研究点 (2)

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