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临床试验/NCT01729767
NCT01729767Unknown2 期

Assessment of Acyclovir Efficacy Versus Placebo in Controlling Vertigo Attacks of Patients With Meniere's Disease Visited in Amiralam Hospital

Tehran University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
80
试验地点
1
主要终点
Vertigo

研究概览

简要总结

Meniere's disease is a chronic illness that affects a substantial number of patients every year worldwide. The disease is characterized by intermittent episodes of vertigo lasting from minutes to hours, with fluctuating sensorineural hearing loss, tinnitus, and aural pressure. It has recently been suggested that viral etiologies specially Herpes virus might be the underlying reason. The investigators study is a randomized, double- blinded placebo-controlled clinical trial in Amiralam Hospital. In this study the primary objective is to assess efficacy of Acyclovir in control of symptoms in patients with Meniere's disease specially their vertigo attacks. Inclusion criteria would be patient's willingness to participate in the study and follow ups, being 18 years old or older, having at least 2 vertigos per month each at least 20 min, interfering with function, and not on medication for Meniere's disease for at least 3 months before the trial. They should not have any history of allergy to Acyclovir, renal insufficiency or Creatinine above 1.5 mg/dl, hepatic enzymes more than three times normal, serious uncontrolled illness, be pregnant or nursing or have previous surgeries on Endolymphatic Sac. Participants will be randomly placed in 2 different arms getting either Acyclovir 400 mg or placebo (inert ingredient). They will take the medication for 10 days 5 times a day, then 3 times a day for next 10 days, and 2 times a day for the last 10 days. Patients will report changes in their symptoms 10 days after initiating the drug and in 1, 3, 6 month intervals.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients' willingness to participate in the study
  • Willingness to participate in follow ups
  • Age of 18 or older
  • Having at least 2 vertigos per month each lasting for at least 20 min, severely interfering with function
  • Not on medication for at least 3 months before starting the trial

排除标准

  • History of Allergy to Acyclovir or the drugs in the same category
  • Renal insufficiency or having Creatinine more than 1.5 mg/dl
  • Hepatic enzymes more than 3 times normal
  • Hematocrit less than 30%
  • Thrombocytopenia
  • Having a serious uncontrolled illness
  • Pregnant or nursing ladies
  • Using Probenecid
  • Previous surgeries on Endolymphatic Sac.

研究组 & 干预措施

Acyclovir

Experimental

Acyclovir 400 mg tablets by mouth 5 times a day for the first month, 3 times a day for next 10 days, and 2 times a day for the last 10 days.

干预措施: Acyclovir (Drug)

Placebo

Placebo Comparator

Placebo tablets by mouth 5 times a day for the first month, 3 times a day for next 10 days, and 2 times a day for the last 10 days.

干预措施: Placebo (Drug)

结局指标

主要结局

Vertigo

时间窗: Change from baseline after 3 months

次要结局

  • Hearing Loss(Change from baseline after 3 months)
  • Aural Fullness(Change from baseline after 3 months)
  • Tinnitus(Change from baseline in 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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