跳至主要内容
临床试验/CTRI/2017/08/009585
CTRI/2017/08/009585已完成Unknown

To study the safety and efficacy of different systemic treatment modalities with antiviral drug for acute pain and chronic pain of herpes zoster- A Pilot study

Dr sanjiv choudhary1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2014年1月14日最近更新:

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
45
试验地点
1
主要终点
Improvement in the severity of pain both in percentage (100-76%: excellent, 75-51%: good, 50-26%: moderate, 25% and less: poor) and grade (mild-pain perceived but day activities and night sleep not affected, moderate- day activities not affected but night sleep affected, severe-both day activities and night sleep affected) was noted.

研究概览

简要总结

Herpes zoster is a viral infection of skin caused by Varicella Zostervirus. The most important symptom for which the patient seeks medical advice ispain which is perceived before the development of rash and lasts even after itsresolution. The pain during first 30 days after onset of herpes zoster is knownas acute herpetic neuralgia. The results of considerable number of recentprospective studies have demonstrated that more the severity of acute pain, greateris the risk of developing post herpetic neuralgia (PHN). There is paucity ofstudies regarding management of acute herpes zoster neuralgia. With thisbackground the study had been designed to target the disease in its initialstage by using potent antiviral drug alone and in combination with antiinflammatory and other pain relieving drug to evaluate their effect on acuteherpetic neuralgia.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • All patients of Herpes zoster of eruptions less than 72 hours duration.
  • Patients with age group 18 years to 70 years of both genders.
  • Patients willing to participate 3) Herpes zoster ophthalmicus without corneal involvement.

排除标准

  • Herpes zoster in pregnant and lactating patients.
  • Age less than 18 years and more than 70 years.
  • Herpes zoster ophthalmicus with keratitis.
  • Herpes zoster patients with diabetes mellitus, hypertension, tuberculosis, gastro-intestinal ulcer disease or with immune-compromised condition 5) Cases of disseminated Herpes zoster infection.
  • Patients of cardiac arrhythmia and cardiac disease 7) Patient with known hypersensitivity for drugs over study.

结局指标

主要结局

Improvement in the severity of pain both in percentage (100-76%: excellent, 75-51%: good, 50-26%: moderate, 25% and less: poor) and grade (mild-pain perceived but day activities and night sleep not affected, moderate- day activities not affected but night sleep affected, severe-both day activities and night sleep affected) was noted.

时间窗: measured at end of 1, 4, 6 weeks

次要结局

  • Patients were monitored for side-effects during follow up period.(monitored at end of 1, 4, 6 weeks)

研究者

发起方
Dr sanjiv choudhary
申办方类型
Other [Acharya Vinoba Bhave Hospital]

研究点 (1)

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