跳至主要内容
临床试验/NCT06213415
NCT06213415尚未招募不适用

Role of Oral Steroid Alone Versus Oral Steroid Plus Intratympanic Steroid Injection in Bell's Palsy

Assiut University0 个研究点目标入组 42 人开始时间: 2024年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
42
主要终点
Success or failure of procedure to treat Bell's palsy

研究概览

简要总结

intratympanic steroid injection bell's palsy

详细描述

Role of oral steroid alone versus oral steroid plus intratympanic steroid injection in Bell's palsy

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mean Aged 18 years or more.
  • Acute unilateral facial palsy without skin lesions which developed within a 72-hour period and is present for 21 days or less.
  • Moderate to severe facial palsy [House-Brackmann grade IV or greater]

排除标准

  • Another cause of facial nerve paralysis that is not idiopathic.
  • Otologic disease including otitis media, temporal bone fracture, a previous history of facial nerve palsy in either side, history of otologic surgery, and suspected Ramsay Hunt syndrome.
  • Systemic disease including history of tuberculosis, history of head and neck cancer, other neurological disorders, recent use of ototoxic medications, liver or renal dysfunction, and other illnesses that would contraindicate the use of high-dose steroid therapy.
  • Pregnancy

研究组 & 干预措施

Oral steroids

Active Comparator

Oral steroids only

干预措施: Corticosteroid (Drug)

Oral steroids plus intratympanic injections

Active Comparator

Oral steroids plus intratympanic injections

干预措施: Corticosteroid (Drug)

结局指标

主要结局

Success or failure of procedure to treat Bell's palsy

时间窗: 6 months

Degree of regaining function to facial nerve Unit of measurement : nerve conduction study Measurement tool :endoscopic injection by ear microscope

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mohamed Alaa Abd-Alraheem

Resident doctor

Assiut University

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