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临床试验/CTRI/2024/07/071384
CTRI/2024/07/071384尚未招募不适用

A Randomized Comparative Clinical Study to Evaluate the Effect of Madhu with Rasanjana Karna Poorana and Clotrimazole 1 Percent Ear Drops in the Treatment of Karnakandu - Otomycosis

Institute for Ayurved Studies and Research1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年8月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
32
试验地点
1
主要终点
1.Changes in Otoscopic Findings.

研究概览

简要总结

Otomycosis is commonly seen in tropical and subtropical regions of the world. The frequency to otomycosis depends upon different climatic conditions with higher prevalence in the hot, humid and dusty areas. Review of the literature reveals otomycosis to be a common medical problem in India. Prevalence rate of Otomycosis in India is about 9%. Honey is the natural food product. It contains number of amino acids, so it has acidic pH. it lyses the fungus and bacteria as it has high osmolarity. Its antifungal, antibacterial action is proved by previous in vitro study. With this background present study is planned to know the effect of Honey in the management of Otomycosis. Rasanjana exhibits antibacterial and antifungal properties and is mentioned under kandughana mahakashaya. In present study, Karnapoorna by Madhu with Rasanjana and Clotrimazole 1% Ear Drops is considered as Topical therapy. So, Karnapoorna by Madhu with Rasanjana have been selected as treatment modalities in the study.

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
16.00 Year(s) 至 60.00 Year(s)(—)

入选标准

  • Patients having signs and symptoms of karnakandu.
  • Patients having signs and symptoms Otomycosis.
  • Patients between 16 to 60 years of age group.
  • Irrespective of Gender, Caste, Religion, Economical Class, Race.
  • Unilateral or bilateral Otomycosis.
  • Intact tympanic membrane.

排除标准

  • below 16 years and above 60 years. 2) CSOM. 3) ASOM. 4) Conductive deafness. 5) Sensorineural Hearing Loss. 6) Mixed hearing loss. 7) Inner ear pathology like acoustic neuroma, Meniere’s disease. 8) Malignancy. 9) Pregnant women. 10) Head injury or injury to ear. 11) History of intake of ototoxic drugs. 12) Patient who needs surgical intervention.

结局指标

主要结局

1.Changes in Otoscopic Findings.

时间窗: 16th day

2.Changes in Smear Examination Findings.

时间窗: 16th day

次要结局

  • Reduction in sign & symptoms of Karnakandu -Otomycosis as under:- 1) Intense Itching.(2) Discomfort or pain in the ear.)

研究者

发起方
Institute for Ayurved Studies and Research
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Gurjeet Singh

Institute For Ayurved Studies and Research Faculty of Ayurved, SKAU Kurukshetra

研究点 (1)

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