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临床试验/CTRI/2019/09/021151
CTRI/2019/09/021151尚未招募2/3 期

Effectiveness of Classical Ayurvedic Protocol of Poothikarna Along With Nirgundyadi Thaila Karnapoorana in Otomycosis

Amrita School of Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年10月9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
30
试验地点
1
主要终点
Fungalmass culture of ear swab

研究概览

简要总结

RATIONALE  Otomycosis also known asfungal otitis externa has typically been described as fungal infection of theexternal auditory canal. The prevalence of otomycosis has been reported to beas low as 9% in cases of otitis externa and as high as 30.4% in patients presentingwith symptoms of otitis or inflammatory conditions of the ear. Moreover itusually occurs most frequently in adults, and less in children. The most commonfungal agents causing otomycosis are Aspergillusniger (80% of case) and Candidaalbicans second common. Several factors have been reported predisposingotomycosis which include; bacterial infections, use of hearing aid or a hearingprosthesis, self inflicted trauma, swimming in contaminated pools, broadspectrum antibiotic therapy, steroids and cytostatic medication, neoplasia andimmune disorders .

OBJECTIVE:-The objective of this study isto test the effectiveness of classical ayurvedic treatment protocol ofputikarna along with Nirgundyadithailakarnapoorana in otomycosis.

STUDY DESIGN: Preand post test study of 30 patients who are fulfilling the inclusion criteriawill be selected for the present clinical study.

Design of the study

After kayasodhana, for first fivedays ear mopping with aragwadadhikasaya, karnadhoopana with gugguluvarthi.Madhupramarjana and pratimarshanasya with anutailawill be done twice daily. On 6th day post fungal culture will be done. If the culture report is negative  from 7th day onwards karnapoorana with nirgundyadithaila asmentioned in classics will be done for a period of 7 days.

Aragwadadhikashaya and tablet willbe administered internally during the treatment course.

 Follow-up - Aftercompletion of the treatment the patients will be advised to report to SalakyaOPD once in a month for a period of three months to assess the sustained effectof treatment.

EXPECTEDCOST – 30000 to40000 INR

Statistical analysis will be done using paired t test

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients of age 18 to 50 years Satisfying the diagnostic criteria Either sex Patients fit for karnapoorana.

排除标准

  • age not within agelimit of 18 to 50 years Patient suffering from any systemic diseases and receiving medication Patient contraindicated for karnapoorana Other types of ear infection apart from otomycosis.

结局指标

主要结局

Fungalmass culture of ear swab

时间窗: Fungalmass culture of ear swab will be done before recruitment of patient for the study and after 5 th day of the study | Aural endoscopic pictures after 5th day and 15 the day of study

Aural endoscopic pictures

时间窗: Fungalmass culture of ear swab will be done before recruitment of patient for the study and after 5 th day of the study | Aural endoscopic pictures after 5th day and 15 the day of study

次要结局

  • VAS scale for pruritis and ear ache Grading of ear blokage(15th day)

研究者

发起方
Amrita School of Ayurveda
申办方类型
Private medical college

研究点 (1)

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