A comparative evaluation of the therapeutic efficiency and safety of Cryo-podophyllin combination versus cryo-imiquimod combination in the treatment of external genital warts in Non-immunocompromised Adults: A Randomized clinical trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Number of cases with complete clearance
研究概览
简要总结
This study is an randomized outcome assessor blinded, parallel group Clinical trial comparing the therapeutic efficiency and safety of cryo- podophyllin combination versus cryo-imiquimod combination in the treatment of genital warts in Non-immunocompromised adults for 16 weeks duration in India. The primary outcome measures will be complete clearance of warts, mean change in number of warts and adverse events while secondary outcome measures will be recurrences at one and three month post treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor 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
- •Newly diagnosed cases for atleast 3 months duration Give informed consent.
排除标准
- •patients having unrealistic expectations or having psychiatric illness patients with renal, cardiac or hepatic disorders immunocompromised patients Pregnancy and lactating mothers.
结局指标
主要结局
Number of cases with complete clearance
时间窗: at baseline at 4 weeks at 8 weeks, 12 weeks and 16 weeks with a follow up period of 3 months
Time taken for complete clearance
时间窗: at baseline at 4 weeks at 8 weeks, 12 weeks and 16 weeks with a follow up period of 3 months
Mean change in number of lesions
时间窗: at baseline at 4 weeks at 8 weeks, 12 weeks and 16 weeks with a follow up period of 3 months
recurrences
时间窗: at baseline at 4 weeks at 8 weeks, 12 weeks and 16 weeks with a follow up period of 3 months
adverse events
时间窗: at baseline at 4 weeks at 8 weeks, 12 weeks and 16 weeks with a follow up period of 3 months
次要结局
- Treatment sessions required for complete clearance of genital warts.(Time taken for complete clearance of genital warts.)
研究者
Dr Rakesh Tilak Raj
Government Medical College Amritsar