Clinical Study on Efficacy and Safety of Nufookh with Unani Formulation in The Management of Otomycosis. A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- 1.Clinical sign and symptoms
研究概览
简要总结
Otomycosis is the fungal infection of the external ear. It is characterized by pain, itching, discharge, ear blockage, hearing loss and ringing in ear. Water entry in ear, scratching of the ear etc. produce favourable atmosphere for fungus. Fungus lodges in that area and starts growing and produces these symptoms. Sign of the Otomycosis is whitish, blackish or brownish fungus in ear. Sometimes wet blotting paper appearance also seen.Tragus tenderness and erythema are also the signs of Otomycosis. In rare cases, primarily in immuno-compromised individuals, the disease may be extensive and involve the temporal bone. Otomycosis is commonly seen in hot and humid climate. The term Otomycosis as a disease is not mentioned in Unani classical literatures , but the some clinical features of Otomycosis are described under the headings of Wajaul uzn ,Warme uzn, Dard gosh and Sailanul nuzn in Unani classical literature. The eminent Unani physicians like Shekh-ur-Rais Ibne Sena, Zakariya Razi and Ahmad al Hasan Aljurjani have mentioned different formulations of Nufookh in the management of various ear diseases. Nufookh is the process in which a grounded & filtered drug blown into the patient’s nose, throat or any other opening of the body through a tube. Treatment consists of thorough ear toilet to remove all discharge and epithelial debris which are conducive to the growth of fungus. It can be done by syringing, suction or mopping. broadspectrum antifungal agents include clotrimazole can be applied. Antifungal treatment should be continued for a week even after apparent cure to avoid recurrences 3 . Nufookh therapy with Unani formulation can be done. Ear must be kept clean and dry
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
- 11.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Clinically diagnosed patient of Otomycosis 2.All gender are included.
排除标准
- •1.Patients with any serious debilitating diseases like malignancies, tuberculosis, and other chronic granulomatous diseases.
- •2.Patients with immune-compromised conditions and history suggestive of fungal diseases elsewhere in the body and those on topical antifungal drops will be excluded from the study.
- •3.Patient suffering from any other aural pathology e.g. Chronic Suppurative Otitis Media (CSOM), Acute Suppurative Otitis Media (ASOM), Perforation of tympanic membrane, etc.
- •will be excluded from the study.
- •4.Patient who refused to give their consent.
结局指标
主要结局
1.Clinical sign and symptoms
时间窗: baseline, 5th, 10th, 15th day
2.Clinical examination
时间窗: baseline, 5th, 10th, 15th day
次要结局
- 1.Post treatment examination (Smear examination by 10%KOH preparation of ear & Fungal culture of ear will be done on 30th day.(30th day)
研究者
Mohd Hammad Athar Ansari
Hakim Syed Ziaul Hasan Government Unani Medical College And Hospital
