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临床试验/CTRI/2025/08/093570
CTRI/2025/08/093570尚未招募4 期

Comparative efficacy of oral, topical and intralesional acyclovir in anogenital warts

Government Medical College and Hospital Chandigarh1 个研究点 分布在 1 个国家入组 45 人开始时间: 2025年9月4日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
To evaluate the resolution of lesions

研究概览

简要总结

Acyclovir, a nucleoside analogue, is an antiviral agent and have shown efficacy as an intralesional agent in warts. Hence may be used for anogenital warts in various administrations. Forty-five consecutive patients of anogenital warts will be recruited for the study and divided into 3 groups of 15 each. Group A patients will be given oral acyclovir in the dose of 400mg thrice a day for 4 weeks. Group B patients will be given topical 5 percent acyclovir cream thrice a day for 4 weeks. Group C patients will be given intralesional acyclovir 70mg per ml once a week for 4 weeks. Each patient shall be followed every week for 4 weeks of therapy and also at additional 4 weeks of stoppage of therapy. Clinical response will be documented at each visit by evaluating the decrease in lesion count, decrease in size of lesions an presence of any side effects.

研究设计

研究类型
干预性
分配方式
随机
盲法
开放(无盲法)

入排标准

年龄范围
14.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • All consecutive patients having lesions of anogenital warts.

排除标准

  • 1.Pregnant or females planning for pregnancy or lactating mothers.
  • 2.Immunocompromised individuals including HIV-AIDS.
  • 3.Patients with known hypersensitivity to acyclovir or its components or any contraindications to acyclovir e.g. renal failure.
  • 4.Patients having any significant systemic illness.
  • 5.Patients having taken any other treatments for anogenital warts in the last 4 weeks.

结局指标

主要结局

To evaluate the resolution of lesions

时间窗: Every week for 4 weeks

次要结局

  • To evaluate the resolution/recurrence of lesions(at 8 weeks, after 4 weeks of stoppage of therapy)
  • To assess the adverse effects of oral, topical and intralesional formulations of acyclovir(8 weeks total study duration)

研究者

发起方
Government Medical College and Hospital Chandigarh
申办方类型
Government medical college
责任方
主要研究者
主要研究者

Dr Rahul Dogra

Government Medical College and Hospital Chandigarh

研究点 (1)

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标识符

CTRI 编号
CTRI/2025/08/093570

日期

最近更新
(去年)

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